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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 470
- Locations
- 66
- Primary Endpoint
- Percentage of Participants Reaching Disease Free Survival
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
- •Negative myeloperoxidase stain
- •Phenotype T (T-ALL) or B (B-ALL)
- •No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)
- •PATIENT CHARACTERISTICS:
- •Creatinine ≤ 2.5 mg/dL (after adequate hydration)
- •SGOT and SGPT ≤ 3 times upper limit of normal
- •LVEF ≥ 50%
- •No severe psychiatric disorders
- •No other concurrent malignant disease
- •No presence of documented infections not responding to antibiotic and/or antifungal therapy
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •No prior steroids
- •No prior antiblastic chemotherapy
- •No other concurrent chemotherapy or radiotherapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants Reaching Disease Free Survival
Time Frame: At 60 months
Secondary Outcomes
- Number of Patients Reaching Complete Hematological Response After Induction Therapy(At the end of induction, day +50)
- Percentage of Participants Reaching Overall Survival(At 60 months)