drugset / Trial / NCT00458848

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

NCT00458848

Phase 2 Completed 470 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Timeline

Start
2004-10
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule
Background Daunorubicin Small molecule
Background Etoposide Small molecule
Background Idarubicin Small molecule
Background MERCAPTOPURINE ANHYDROUS Small molecule
Background Methotrexate Small molecule
Background Methylprednisolone Other / unclassified
Background Mitoxantrone Small molecule
Background Prednisone Other / unclassified
Background Vincristine Small molecule
Background asparaginase Protein / enzyme biologic

Indications