Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Philadelphia Chromosome

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Robin Foà, MD, PhD

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.

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.

Treatment of Adult Ph+ LAL With BMS-354825

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'Adulto

Physicians reporting whenever a SAE happened.

Age, Continuous

Gender

White Blood Cells

Dr. Paola Fazy; Dr. Marco Vignetti

Study Group

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).

The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;

The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;

DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;

the Cumulative Incidence of Relapse;

OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Adult Ph+ LAL With BMS-354825	NCT00391989	Lymphoblastic L...	Dasatinib	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto
Treatment of Adult Ph+ LAL With BMS-354825	NCT00391989	Lymphoblastic L...	Dasatinib	18 Years -	Gruppo Italiano Malattie EMatologiche dell'Adulto

Spots Global Cancer Trial Database for ph+ acute lymphoblastic leukaemia