Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia (LAL0904)
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.
|Leukemia||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||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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.|
- Disease-free survival [ Time Frame: At 4 years from study entry ]Evaluation of disease free survival in patients with high risk of remission obtaining a Complete Remission as from the date of hematological complete remission.
- Complete response after HAM [ Time Frame: At 4 years from study entry ]Evaluation, in terms of complete response, of HAM as 2nd line treatment in resistant patients not in progression after the 2nd or 3rd induction cycle
- Feasibility of minimal residual disease (MRD) monitoring [ Time Frame: At 4 years from study entry ]Feasibility of minimal residual disease in hight and standard risk patients
- Negative prognostic role of MRD positivity [ Time Frame: At 4 years from study entry ]
- Rate of complete hematological response after induction therapy in Ph+ patients [ Time Frame: At 4 years from study entry ]
- Disease free survival in Ph+ patients [ Time Frame: At 4 years from study entry ]
- Cumulative incidence of relapse [ Time Frame: At 4 years from study entry ]
- Molecular monitoring of BCR/ABL after complete hematological response [ Time Frame: At 4 years from study entry ]
- Overall survival [ Time Frame: At 4 years from study entry ]Overall survival from diagnosis
|Study Start Date:||October 2004|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458848
Show 66 Study Locations
|Study Chair:||Roberto Foa, MD||Universita Degli Studi "La Sapeinza"|