A Phase II Multicenter Study on the Treatment of Adult de Novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) With the Protein Tyrosine Kinase Inhibitor BMS-354825. EudraCT Number 2005-005107-42.

Gruppo Italiano Malattie EMatologiche dell'Adulto36 sites in 1 country53 target enrollmentSeptember 2006

ConditionsLymphoblastic Leukemia, Acute

DrugsDasatinib

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lymphoblastic Leukemia, Acute
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Enrollment: 53
Locations: 36
Primary Endpoint: Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

Detailed Description

This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

September 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with Ph+ and/or BCR/ABL+ ALL
•Age ≥18 years old
•De novo ALL (within 14 days from diagnosis)
•No prior treatment with any anti-leukemic drugs with the exception of steroids for no more than 14 days (including the 7-day pretreatment already scheduled in the protocol)
•WHO performance status ≤2
•Absence of central nervous system (CNS) leukemia
•Normal serum level of potassium, total calcium corrected for serum albumin magnesium and phosphorus, or correctable with supplements
•ALT and AST ≤2.5 x ULN or ≤5.0 x ULN if considered due to leukemia
•Alkaline phosphatase ≤2.5 x ULN unless considered to leukemia
•Serum bilirubin ≤2 x ULN

Exclusion Criteria

•Impaired cardiac function, including any one of the following:
•Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BMS-354825 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection)
•Use of therapeutic warfarin
•Acute or chronic liver or renal disease considered unrelated to leukemia
•Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
•Treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM¬CSF) ≤1 week prior to starting study drug
•Patients who are currently receiving treatment with any of the medications listed in "Appendix F" and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in "Appendix F" have the potential to prolong the QT interval.
•Patients who have received any anti-leukemic agents and treatments including steroids for more than 14 days including 7 days pretreatment that is part of the protocol
•Patients who have received any investigational drug in the last 2 weeks
•Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Outcomes

Primary Outcomes

Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).

Time Frame: End of the study, up to day 85

Secondary Outcomes

DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;(End of study)
The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;(End of study)
the Cumulative Incidence of Relapse;(End of study)
The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;(End of study)
the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;(End of study)
OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.(End of study)