Phase 2
N=51
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00458848 ↗Enrolled (actual)
51
Serious AEs
13.7%
Results posted
Feb 2019
Primary outcome: Primary: Percentage of Participants Reaching Disease Free Survival — 45.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Drug); allogeneic hematopoietic stem cell transplantation (Procedure); autologous hematopoietic stem cell transplantation (Procedure); peripheral blood stem cell transplantation (Procedure); radiation therapy (Radiation)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reaching Disease Free Survival |
45.8 | — |
| SECONDARY Number of Patients Reaching Complete Hematological Response After Induction Therapy |
49 | — |
| SECONDARY Percentage of Participants Reaching Overall Survival |
48.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00458848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.