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A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase

Phase 2
18 Years
Open (Enrolling)
Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia

Thank you

Trial Information

A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase


I. Compare the rate of molecular response, as measured by the decrease in bcr-abl
transcripts after 12 months of treatment, in patients with previously untreated chronic
phase chronic myelogenous leukemia treated with imatinib mesylate at standard vs increased
dose or dasatinib.

II. Test whether increasing dose of imatinib mesylate from 400 mg/day to 800 mg/day
increases molecular response rate (as measured by decrease in bcr-abl transcript after 12
months of treatment) in these patients.

III. Compare rates of cytogenetic and hematologic response in patients treated with these

IV. Compare, preliminarily, the prognostic effects of der(9) and der(22) chromosomal
deletions for response in patients treated with these regimens.

V. Compare, preliminarily, changes in gene expression at pre-treatment vs at relapse or
progression in patients treated with these regimens.

VI. Compare the frequency and severity of the toxic effects of these regimens in these

VII. Compare, preliminarily, the overall survival and relapse-free survival of patients
treated with these regimens.


This is a randomized, multicenter study. Patients are stratified according to Hasford risk
category (low vs intermediate vs high). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive oral imatinib mesylate once daily.

ARM II: Patients receive oral imatinib mesylate twice daily.

ARM III: Patients receive oral dasatinib twice daily.

In all arms, treatment continues for 5 years in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed for up to 5 years.

Inclusion Criteria


- Diagnosis of chronic phase chronic myelogenous leukemia (CML) by bone marrow
aspiration, biopsy, and peripheral blood counts, meeting criteria for 1 of the

- Philadelphia chromosome-positive* or presence of the variants of the (9;22)
translocation by cytogenetics or fluorescent in situ hybridization

- Secondary chromosomal abnormalities (in addition to the Philadelphia chromosome)
allowed; bcr-abl positive* by reverse transcription polymerase chain reaction
[Note: *First cytogenetic or molecular analysis performed within the past 180
days to confirm status]

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- Must be enrolled on SWOG-9007 (SWOG institutions only) and SWOG-S9910

- No significant bleeding disorder unrelated to cancer including:

- Congenital bleeding disorders (e.g., von Willebrand's disease)

- Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII

- Bilirubin no greater than 2.0 times upper limit of normal (ULN)

- AST or ALT no greater than 2.0 times ULN

- No cardiac symptoms including any of the following:

- Uncontrolled angina

- Congestive heart failure or myocardial infarction within the past 6 months

- Diagnosed or suspected congenital long QT syndrome

- History of clinically significant ventricular arrhythmias (e.g., ventricular
tachycardia, ventricular fibrillation, or Torsades de pointes)

- Prolonged QTc interval on electrocardiogram (> 450 msec)

- Uncontrolled hypertension

- Zubrod 0-2

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other concurrent anticancer biologic agents

- No prior chemotherapy for peripheral blood stem cell mobilization

- Prior collection of unmobilized peripheral blood stem cells allowed

- No other concurrent anticancer chemotherapy

- Concurrent hydroxyurea and/or anagrelide to control blood counts allowed provided it
is only administered during the first 28 days of study therapy and for no more than
28 additional days after study therapy

- No concurrent anticancer radiotherapy

- More than 28 days since prior major surgery and recovered

- No prior treatment for CML (except hydroxyurea and/or anagrelide)

- No concurrent therapeutic anticoagulation with warfarin

- Concurrent therapeutic anticoagulation with low-molecular weight heparin allowed

- Concurrent low-dose warfarin for prophylaxis to prevent catheter thrombosis allowed
(arm III only)

- No concurrent drugs* that have a risk of causing Torsades de Pointe including (arm
III patients only):

- Quinidine

- Procainamide

- Disopyramide

- Amiodarone

- Sotalol

- Ibutilide

- Dofetilide

- Erythromycin

- Clarithromycin

- Chlorpromazine

- Haloperidol

- Mesoridazine

- Thioridazine

- Pimozide

- Cisapride

- Pepridil

- Droperidol

- Methadone

- Arsenic

- Chloroquine

- Domperidone

- Halofantrine

- Levomethadyl

- Pentamidine

- Sparfloxacin

- Lidoflazine [Note: *Patients who have discontinued any of these medications must
have a wash-out period of at least 5 days or at least 5 half-lives of the drug
prior to first dose of dasatinib]

- No concurrent drugs that irreversibly inhibit platelet function, including any of the
following (arm III only):

- Aspirin

- Patients who have discontinued aspirin must have a wash-out period of at
least 7 days for low-dose aspirin (< 325 mg/day) or 14 days for high-dose
aspirin (> 325 mg/day) prior to first dose of dasatinib

- Dipyridamole

- Epoprostenol

- Eptifibatide

- Clopidogrel

- Cilostazol

- Abciximab

- Ticlopidine

- No other concurrent anticancer agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Molecular Response Rate at 12 Months

Outcome Description:

Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.

Outcome Time Frame:

pretreatment and after 12 months of treatment

Safety Issue:


Principal Investigator

Brian Druker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Phase Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase



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