Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML

Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Clinical Trial

Official title:
A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Status Completed

Clinical Trial Summary

This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Leukemia
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Myeloid Leukemia, Chronic, Accelerated Phase
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT00123487
Study type	Interventional
Source	Bristol-Myers Squibb
Contact
Status	Completed
Phase	Phase 3
Start date	June 2005
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05495035` - Study for Safety and Efficacy of Olverembatinib Combined With APG-2575 in Children With Relapsed/Refractory Ph + ALL	Phase 1
Terminated	`NCT00500006` - A Phase I Dose Escalation Combination Study in Patients With Chronic Myelogenous Leukemia (CML) and Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)(0457-009)(TERMINATED)	Phase 1
Completed	`NCT00103701` - BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia	Phase 1
Terminated	`NCT01100658` - Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors	N/A
Terminated	`NCT00464113` - Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia	Phase 1
Terminated	`NCT00907517` - Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)	Phase 1
Terminated	`NCT01761682` - Acute Lymphoblastic Leukemia Registry at Asan Medical Center
Completed	`NCT00101595` - Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Phase 2
Completed	`NCT01310010` - Study of Dasatinib to Treat Philadelphia Positive Acute Lymphoblastic Leukemia	Phase 2