Clinical Trials-

Please find below links to Clinical Trials relevant to CML in the US, UK, EU countries and other regions.
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A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novartis
Sponsor: Novartis Pharmaceuticals

Detailed Description:
This first-in-human trial with ABL001 is a dose escalation study whose primary purpose is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of single agent ABL001 in CML or Ph+ ALL patients, and in combination with Nilotinib in Ph positive CML patients. The safety, tolerability and pharmacokinetic (PK) profile of ABL001 and ABL001+Nilotinib will be assessed together with an evaluation of pharmacodynamic (PD) changes in peripheral blood mononuclear cells (PBMC) and bone marrow aspirates and all data may contribute to the assessment of the RDE.

An understanding of the MTD/RDE, safety profile, PK/PD relationship, and preliminary evidence of anti-CML and ALL activity will be used to inform future development in adults with CML and Ph+ ALL. By virtue of its distinct pharmacological profile and by preclinical pharmacological studies demonstrating an additive effect, a combination of ABL001 and a tyrosine-kinase inhibitor (TKI) has the potential to achieve a deeper molecular response in a higher proportion of CML patients as compared to single agent TKI therapy. Such a combination has the added advantage of targeting the ABL kinase domain at two distinct locations, theoretically preventing single point mutation-associated treatment resistance. The prediction is that a nilotinib/ABL001 combination will increase the percentage of patients who achieve a complete molecular response (CMR) and decrease the time to CMR, thereby increasing the possibility of achieving sustained treatment-free remissions in these patients. In addition, some patients may be intolerant of therapy with TKIs or may develop mutations that promote resistance to TKI therapy. In these patients, ABL001 may provide a novel therapeutic option.
Locations:
United States, Australia, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Singapore, Spain

http://clinicaltrials.gov/ct2/show/study/NCT02081378?term=CML&rank=22

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Bfore- A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia



This study is currently recruiting participants: see Contacts and Locations

Verified September 2014

Avillion Development 1 Limited

Primary Outcome Measures:
Compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR)

Secondary Outcome Measures:

Compare proportion of participants with MMR at 18 Months in the bosutinib treatment group with the imatinib treatment group [ Time Frame: 18 Months ]


To determine the duration of MMR in the bosutinib treatment group with the imatinib treatment group [ Time Frame: 5 Years ]


Duration of MMR is measured only for participants who initially respond to study medication.


To determine the proportion of participants with Complete Cytogenetic Response (CCyR) by 12 Months in both treatment groups [ Time Frame: 12 Months


CCyR is defined as absence of detectable Ph chromosomes in bone marrow aspirate


To determine the duration of CCyR in both treatment groups [ Time Frame: 5 Years ]



Duration of response is measured only for participants who initially respond to study medication.

Estimated Enrollment: 530

Study Start Date: June 2014

Estimated Study Completion Date: May 2020

Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Arms Assigned

Experimental: Bosutinib

Bosutinib, 400 mg, oral administration once a day



Active Comparator: Imatinib

Imatinib, 400 mg, oral administration once a day

Detailed Description:

The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years (240 weeks) after randomization.



www.clinicaltrials.gov/NCT02130557

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DASFREE - Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response.
This study is currently recruiting participants.
Verified: February 2014 by Bristol-Myers Squibb
Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party):Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01850004

Primary Purpose:
MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Every 3 months in years 2 to 5 ] [ Designated as safety issue: No ]

MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Monthly once up to first year ] [ Designated as safety issue: No ]

Major Molecular Response (MMR) is defined as BCR-ABL transcripts <0.1% on International Scale, at 12 month after Dasatinib discontinuation in patients who have maintained MMR without re-starting Dasatinib
Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs.

Estimated Enrollment: 79
Study Start Date: February 2014
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Contacts and Locations: United States, Canada, Finland, France, Germany, Italy, Spain

http://clinicaltrials.gov/ct2/show/NCT01850004?term=CML+Dasatinib&rank=25

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DESTINY - De- Escalation and Stopping Treatment of Imatinib, Nilotinib or sprYcel in Chronic Myeloid Leukaemia

http://www.lctu.org.uk/trial/trial_info.asp?id=101&tgcode=5&menuid=30

http://clinicaltrials.gov/ct2/show/NCT01804985?term=DESTINY&rank=3

This study is currently recruiting participants.
Verified January 2014 by University of Liverpool
Sponsor: University of Liverpool

Collaborators:
Newcastle University
Imperial College London
University of Glasgow
Information provided by (Responsible Party): Professor Richard E Clark, University of Liverpool

ClinicalTrials.gov Identifier: NCT01804985
First received: March 3, 2013
Last updated: January 9, 2014
Last verified: January 2014

Purpose
The purpose of this study is to investigate whether some patients with excellent responses to chronic myeloid leukaemia (CML) treatment are being overtreated, and can remain well on either a lower dose of treatment or without treatment at all. The dose of imatinib (Glivec), nilotinib (Tasigna) or dasatinib (Sprycel) treatment will initially be cut to half the standard dose for 12 months, and then treatment will be stopped completely for a further two years. The trial information will also help to develop a de-escalation and stopping strategy for future newly diagnosed CML patients in the next British national CML study (to be known as SPIRIT3).

Primary Outcome Measures:
• The proportion of patients who can first de-escalate their treatment (to half the standard dose of their TKI) for 12 months, and then stop treatment completely for a further 2 years, without losing MMR. [ Time Frame: 37 months ] [ Designated as safety issue: No ]
• The proportion of patients who can first de-escalate their treatment (to half the standard dose of their TKI) for 12 months, and then stop treatment completely for a further 2 years, without losing MMR.

Secondary Outcome Measures:
• Proportion of patients who can successfully de-escalate their treatment (to half the standard dose of their TKI), but who then lose MMR on complete TKI cessation [ Time Frame: 37 months ] [ Designated as safety issue: No ]
•Proportion of patients who can successfully de-escalate their treatment (to half the standard dose of their TKI), but who then lose MMR on complete TKI cessation
• Proportion of patients who lose their MMR on de-escalation/stopping and regain MMR on resumption of their TKI [ Time Frame: 37 months ] [ Designated as safety issue: No ]
•Proportion of patients who lose their MMR on de-escalation/stopping and regain MMR on resumption of their TKI
Estimated Enrollment: 168
Study Start Date: December 2013 Estimated Study Completion Date: December 2017

Detailed Description:
The next definitive UK phase III trial in chronic myeloid leukaemia (CML) will be SPIRIT3, which will open in Summer 2014. This will incorporate a de-escalation and stopping strategy for patients who achieve excellent responses after at least 3 years of treatment with a tyrosine kinase inhibitor (TKI).

DESTINY is to act as a pilot for this strategy in SPIRIT3, by defining the proportion of patients that relapse during 12 months of TKI de-escalation followed by 24 months of cessation. DESTINY also includes scientific bolt-on studies, quality of life assessments and health economic evaluation.

Inclusion Criteria:
*CML in first chronic phase.
*Demonstration of BCR-ABL1 positivity at/shortly after original diagnosis.
*Written Informed Consent
*Must have received TKI treatment for at least 3 years.
*At least 3 molecular results over the preceding 12 months, that fit either of the following groups (results from any UK lab are acceptable):
*MR4 group- all the available BCR-ABL1 molecular results over the preceding 12 months are in MR4 (MR4 is defined as a BCR-ABL1/ABL1 ratio of zero, with at least 10,000 ABL1 control transcripts).
*MMR group - some or all BCR-ABL1 molecular results are in major molecular response (MMR, defined here as a BCR-ABL1/ABL1 ratio of 0.1% or less, but not zero, with at least 10,000 ABL1 control transcripts).
If the results over the preceding 12 months are a mix of MMR and undetectable BCR-ABL1, then the patient is eligible for the MMR but not the MR4 group.

Contact:
Tony Coffey: tony.coffey@liverpool.ac.uk
Julie Perry: julie.perry@liverpool.ac.uk

SPIRIT 3
The next definitive UK phase III trial in chronic myeloid leukaemia (CML) will be SPIRIT3, which will open in the first quater of 2015. This will incorporate a de-escalation and stopping strategy for patients who achieve excellent responses after at least 3 years of treatment with a tyrosine kinase inhibitor (TKI).

DESTINY is to act as a pilot for this strategy in SPIRIT3, by defining the proportion of patients that relapse during 12 months of TKI de-escalation followed by 24 months of cessation.

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ENESTFreedom: Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
This study is currently recruiting participants.
Estimated Enrollment ICMJE: 175
Estimated Completion Date: January 2019
Estimated Primary Completion Date : October 2018
(final data collection date for primary outcome measure)

First received: January 30, 2013
Last updated: December 4, 2013
Verified June 2014 by Novartis
Sponsor: Novartis Pharmaceuticals
Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier: NCT01784068

Primary Outcome Measures:
Percentage of patients who are in MMR (major molecular response) at 48 weeks after starting the treatment-free remission (TFR) phase [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Primary endpoint is the proportion of patients who are in MMR at 48 weeks after starting the TFR phase and is calculated by dividing the number of patients with MMR at 48 weeks after starting the TFR phase with no loss of MMR and no re-initiation of nilotinib therapy in the first 48 weeks after starting the TFR phase by the number of patients entered the TFR phase. Patients who required re-initiation of treatment will be considered as non-responders

Secondary Outcome Measures:
Percentage of patients who are in MR4.5 (BCR-ABL ≤ 0.0032% IS) at 48 weeks after starting the TFR phase [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Proportion of patients who are in MR4.5 at 48 weeks after starting the TFR phase is calculated by dividing the number of patients with MR4.5 at 48 weeks after starting the TFR phase with no loss of MR4.5 and no re-initiation of nilotinib therapy in the first 48 weeks after starting the TFR phase by the number of patients who entered the TFR phase. Patients who required re-initiation of treatment will be considered as non-responders. MR4.5 = log reductions of the BCR-ABR transcript load in blood as a measurement of deep molecular response of the CML clone to treatment.

Arms Assigned Interventions
Experimental: Nilotinib followed by treatment-free
Patients who have received a minimum of 2 years of first line nilotinib treatment and with pre-screen PCR results in ≥ MR4.5 will enter the consolidation phase of the study (52 weeks - nilotinib 300 mg BID). Patients with Minimal Residual Disease (MRD) at the end of this phase will enter the Treatment-Free Remission (TFR) phase where no treatment is given.
Non eligible patients will enter the continuation phase of the study.
Patients with MRD at the end of the continuation phase will enter the TFR-2 phase of the study where no treatment is given.
Non eligible patients will enter the prolonged continuation phase of the study. If at any time during TFR or TFR-2 the patient loses MMR, nilotinib treatment will be immediately re-initiated (nilotinib 300 mg BID).

Location Countries ICMJE : United States, Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom

http://www.clinicaltrials.gov/ct2/show/study/NCT01784068?cond=%22Leukemi...
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ENESTPath -Randomized Phase III Study to Assess the Effect of Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:Novartis Pharmaceuticals


http://clinicaltrials.gov/ct2/show/study/NCT01743989?show_locs=Y#locn


Purpose
This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months after starting the Treatment-Free Remission (TFR) phase of the study.

Rationale:
CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment, and who have failed to achieve the molecular response threshold for treatment cessation (≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal duration of consolidation treatment with nilotinib to ensure the highest rate of patients remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore aims to assess the potential impact of a longer duration of consolidation treatment with nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months of treatment-free remission.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Key Inclusion Criteria:
Confirmed diagnosis of chronic phase Ph+ CML
Previous first-line treatment with imatinib for a minimum of 2 years;
Patient in complete cytogenetic response;


Key Exclusion Criteria:
Previous achievement of MR4.0 at study entry;
Previous treatment with other target cells inhibitors other than imatinib;
Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
Patients who have not recovered from prior surgery;
Treatment with other investigational agents within 4 weeks of Day 1;
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug;

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ENESTop - Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib

http://clinicaltrials.gov/ct2/show/record/NCT01698905?term=CML&cntry1=NA...

This study is currently recruiting participants.
Verified February 2014 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01698905

Purpose
A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

Inclusion Criteria:
Male or female patients >= 18 years of age
ECOG Performance Status of 0, 1, or 2
Patient with diagnosis of BCR-ABL positive CML CP
Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
Patient has at least 2 years of nilotinib treatment prior to study entry.
Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
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EURO-SKI - European Stop Tyrosine Kinase Inhibitor Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by European LeukemiaNet

Sponsor: European LeukemiaNet
Information provided by (Responsible Party): European LeukemiaNet
ClinicalTrials.gov Identifier: NCT01596114

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.

Secondary goals include:
Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
Evaluation of quality of life (QoL) in patients stopping TKI
Evaluation of medico-economic impact of stopping TKI
Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory).
Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500.

http://clinicaltrials.gov/ct2/show/NCT01596114?term=STIM+3&rank=12
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STIM 2 - Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib
This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor: University Hospital, Bordeaux
Information provided by (Responsible Party): University Hospital, Bordeaux

Last verified: April 2014
Sponsor: City of Hope Medical Center
Collaborator: National Cancer Institute (NCI)
Summary

RATIONALE: Panobinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE:
This phase I trial is studying the side effects and best dose of panobinostat when given together with imatinib in treating patients with previously treated chronic phase chronic myelogenous leukemia.

Further Study Information:
OBJECTIVES:
Primary:
To determine the safety and tolerability of LBH589 given in combination with imatinib mesylate in CML patients who are in Major Cytogenetic Remission (MCR) with residual BCR-ABL positive cells after at least 1 year of daily imatinib mesylate treatment.
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity of LBH589 given in combination with imatinib mesylate in CML patients.
Secondary
To study the effect of LBH589 given in combination with imatinib mesylate on cytogenetic response status and BCR-ABL levels in CML patients in major cytogenetic remission on imatinib mesylate treatment.
Tertiary
To study the effect of LBH589 given in combination with imatinib mesylate on residual BCR-ABL positive primitive progenitors in CML patients in major cytogenetic remission on imatinib mesylate treatment.

OUTLINE: This is dose-escalation study of panobinostat.

Patients receive oral panobinostat once daily on days 1, 3 and 5; 8, 10, and 12; 15, 17, and 19; and 22, 24, and 26. Patients also receive oral imatinib mesylate once daily on days 1-28. Treatment repeats every 21 or 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and then every 3 months for up to 1 year.

http://www.cancer.gov/clinicaltrials/search/view?cdrid=596065&version=He...

http://clinicaltrials.gov/show/NCT00686218

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EPIC: Ponatinib in Newly Diagnosed CML

This study has been terminated.
(Study terminated based on evaluation of safety data.)

Sponsor: Ariad Pharmaceuticals
Information provided by (Responsible Party):
Ariad Pharmaceuticals ClinicalTrials.gov Identifier: NCT01650805
First received: July 18, 2012
Last updated: October 18, 2013
Last verified: October 2013

This multicenter, international,Phase 3 Randomized, Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

http://clinicaltrials.gov/ct2/show/NCT01650805?term=PONATINIB&rank=15

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Nilotinib and LDE225 in the Treatment of Phase Chronic Myeloid Leukemia Patients Who Developed Resistance to Prior Therapy
This study has been completed

Verified April 2014
Sponsor:Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT01456676
Last updated: September 30, 2012

Phase 1 study: Nilotinib and LDE225 in the Treatment of Phase Chronic Myeloid Leukemia Patients Who Developed Resistance to Prior Therapy
Official Title ICMJE: A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors

Brief Summary:
The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with phase chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.

http://clinicaltrials.gov/ct2/show/record/NCT01456676

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Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib (CML1113)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto.

Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier: NCT01761890
Last verified: January 2013

Start Date ICMJE February 2013
Estimated Primary Completion Date February 2017

The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases.

The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.

In summary, 1) Most data on second generation TKIs are from company-sponsored studies; 2) The high rate of study discontinuation observed within the phase III study may influence the data interpretation; 3) A long-term post-marketing surveillance in large independent trial is extremely important to confirm the efficacy in a nationwide experience; 4) The persistence of CMR after TKI discontinuation have been described in selected patients with "deep" molecular response; 5) A stable CMR is a pre-requisite for treatment discontinuation; 6) A detailed description of the kinetic of the molecular response, potentially related to a subsequent treatment discontinuation, will be done.

http://www.clinicaltrials.gov/ct2/show/NCT01761890?cond=%22Leukemia%2C+M...
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SIMPLICITY: Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT01244750

Last Updated Date February 12, 2013
Start Date ICMJE October 2010
Estimated Primary Completion Date December 2017 (final data collection date for primary outcome measure)

Primary Outcome Measures:
The rate of Complete Cytogenetic Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The duration of initial TKI treatment [ Time Frame: 5-years from study index date ] [ Designated as safety issue: No ]
Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

The rate of discontinuation and treatment changes after initial TKI treatment [ Time Frame: Every 6 months for a follow-up period of 5-years from study index date ] [ Designated as safety issue: No ]
Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)

http://www.clinicaltrials.gov/ct2/show/NCT01244750?cond=%22Leukemia%2C+M...

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ChOICES
A Randomised phase II trial of Imatinib (IM) versus hydroxycholorquine (HCQ) and IM for patients with Chronic Myloid Leukaemia (CML) in Major Cytogenetic Response (MCyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR).

UK Multi centre: currently recruiting in Scotland, England and N.Ireland:
Chief Investigator: Prof Tessa Holyoake
Current Status Open
Closure Date 9/30/2014
Global Sample Size 66
Global Recruitment to Date - 81%

Research Summary
This is a randomised phase 2 trial with a safety run-in, designed to study the safety and efficacy of HCQ in combination with Imatinib. CML CP patients who are in MCyR after >1 and <3 years of Imatinib treatment and tolerating Imatinib well will be randomised between Imatinib alone and Imatinib and HCQ 800mg/day. Imatinib will be given at the patient’s current stable dose. Treatment will be given continuously. Treatment with IM + HCQ will be continued for 12 cycles to further study tolerance and to study the efficacy of the combination to reduce or eliminate BCR/ABL+ cells. 33 patients will be randomised to each treatment to a total of 66 patients, recruited in 3 centres. Time required for accrual of all patients is anticipated to be 24 months. Time on study IM + HCQ treatment for each patient is 12 months. Follow-up assessments for each patient continue to 24 months. All patients will continue on their daily dose of Imatinib treatment that they were receiving prior to entry in the trial.

http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8492

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SPIRIT 2

STI571 Prospective International RandomIsed Trial 2: A phase III, prospective randomised comparison of imatinib (STI571, Glivec/Gleevec) 400mg daily versus dasatinib (Sprycel) 100mg daily in patients with newly-diagnosed chronic phase chronic myeloid leukaemia.

Research Summary
SPIRIT2 is a Phase III, multicentre, open-label, prospective randomised trial comparing imatinib 400 mg daily versus dasatinib 100 mg daily in patients with newly-diagnosed chronic phase Chronic Myeloid Leukaemia (CML).

UK Multi-Centre
Lead Country England (also active in Scotland and Northern Ireland and Wales)

Current Status Closed - in follow-up
Closure Date 3/8/2013
Global Sample Size- 810
Global Recruitment to Date- 100%

http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5266

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2013

Feb 2013
DASAPOST: Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase

SPAIN: Multicenter, Open-label, Non-randomized Phase II Trial of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CP-CML) Who Meet Criteria for Late Suboptimal Response After Prior Imatinib Treatment.

This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib.

All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first.

Recruitment of 65 patients starts March 2013: Study ends March 2015

http://www.clinicaltrials.gov/ct2/show/record/NCT01802450?

http://www.onclive.com/specialty/hematologic-cancer

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