Clinical trial · Interventional
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
- 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)
This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Conditions
Conditions (1)
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 Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- A1
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- A2
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- A3
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- B1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Philadelphia chromosome positive or bcr-abl gene positive * Chronic Myelogenous Leukemia (CML) * Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate * Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL) * Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy * Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2 * Men and women, ages 20 - 75 * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized Exclusion Criteria: * Subjects who are eligible and willing to undergo transplantation at pre-study * Women who are pregnant or breastfeeding * Uncontrolled or significant cardiovascular disease * History of significant bleeding disorder unrelated to CML or ALL * Adequate hepatic function * Adequate renal function * Medication that increase bleeding risk * Medication that change heart rhythms * Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
References
Publications (0)
Data not yet available