NCT00458848

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

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	asparaginase
DRUG	daunorubicin hydrochloride
DRUG	etoposide
DRUG	idarubicin
DRUG	imatinib mesylate
DRUG	mercaptopurine
DRUG	methotrexate
DRUG	methylprednisolone
DRUG	mitoxantrone hydrochloride
DRUG	prednisone
DRUG	vincristine sulfate
PROCEDURE	allogeneic hematopoietic stem cell transplantation
PROCEDURE	autologous hematopoietic stem cell transplantation
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	radiation therapy

Timeline

• Start date: 2004-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2007-04-11
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

66 sites across 1 country: Italy