Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial

Official title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825)

Status Active, not recruiting

Clinical Trial Summary

This randomized phase II trial studies how well dasatinib works in treating patients with early chronic phase chronic myelogenous leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To estimate the proportion of patients with previously-untreated chronic phase chronic myelogenous leukemia (CML) attaining major molecular response by 12 months of treatment with dasatinib.

SECONDARY OBJECTIVES:

I. To estimate the proportion of patients with Philadelphia chromosome (Ph)-positive early chronic phase CML achieving a complete cytogenetic response after dasatinib therapy.

II. To evaluate the durations of hematologic, cytogenetic and molecular response to dasatinib.

III. To define the time to progression and overall survival for patients with CML in early chronic phase treated with dasatinib.

IV. To evaluate the toxicity profile of dasatinib in patients with CML in early chronic phase.

V. To evaluate the probability of developing c-abl oncogene 1, non-receptor tyrosine kinase (ABL) mutations for patients with CML in early chronic phase treated with dasatinib.

VI. To analyze differences in response rates and in prognosis within different risk groups and patient characteristics.

VII. To assess correlation between trough concentration and pleural effusion. VIII. To assess the inhibition of platelet function and assess correlation between drug concentration and degree of platelet inhibition.

IX. To assess the effect of dasatinib therapy in bone metabolism as determined by changes in serum alkaline phosphatase (bone specific isoenzyme), and trabecular bone volume.

X. To evaluate symptom burden in patients with CML receiving dasatinib.

EXPLORATORY OBJECTIVE:

I. To investigate the plasma/serum levels of specific micro ribonucleic acids (miRNAs) in CML patients receiving dasatinib as initial therapy for CML in chronic phase (CP).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive dasatinib orally (PO) once daily (QD) for up to 15-18 years.

ARM B: Patients receive dasatinib PO twice daily (BID) for up to 15-18 years.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically. ;

Related Conditions & MeSH terms

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

• NCT number: NCT00254423
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 8, 2005
• Completion date: November 30, 2024