Clinical trial · Interventional
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d
NCT00103844CI-TRIAL-00003768completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Philadelphia-Positive Myeloid Leukemia | Myeloid Leukemia, Philadelphia-Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Active Comparator
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- 2
- description
- Active Comparator
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
- timeFrame
- Week 12
- description
- Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, 18 years of age or older. * Subjects with Chronic Phase Ph+ CML. * Subjects have not been treated with imatinib at a dose \>600 mg/day. * Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day. * Able to tolerate imatinib at the highest dose the subject had received in the past. * Demonstrate adequate renal and hepatic function. * Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception. Exclusion Criteria: * Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study. * Women using a prohibited contraceptive method. * Women who are pregnant or breastfeeding. * Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above. * Prior treatment with imatinib at a dose \>600 mg/day. * Subjects who have previously identified specific BCR-ABL mutations. * Previous diagnosis of accelerated phase or blast crisis CML. * Intolerance to imatinib at any dose. * Subjects who are eligible and willing to undergo transplantation during the screening period. * Serious uncontrolled medical disorder or active infection. * Uncontrolled or significant cardiovascular disease. * Uncontrolled hypertension. * Dementia or altered mental status. * Evidence of organ dysfunction. * Use of imatinib within 7 days. * Use of interferon or cytarabine within 14 days. * Use of a targeted small molecule anticancer agent within 14 days. * Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes. * Subjects taking medications that irreversibly inhibit platelet function or anticoagulants. * Prior therapy with BMS-354825.
References
Publications (2)
- BACKGROUNDKantarjian H, Pasquini R, Levy V, Jootar S, Holowiecki J, Hamerschlak N, Hughes T, Bleickardt E, Dejardin D, Cortes J, Shah NP. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009 Sep 15;115(18):4136-47. doi: 10.1002/cncr.24504. PMID 19536906
- BACKGROUNDMuller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24. PMID 19779040