Acute lymphoblastic leukemia MedDRA version: 14.1 Level: LLT Classification code 10024338 Term: Leukemia lymphoblastic acute System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Glivec/ Gleevec
Pharmaceutical Form:
INN or Proposed INN: imatinib
CAS Number: 152459-95-5
Other descriptive name: IMATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Children's Oncology Group (COG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 1 to 20 years of age diagnosed with ALL who achieve remission after frontline induction therapy must have one of the features listed below: a. Ph+ ALL: presence of t(9;22)(q34;q11) determined by institutional cytogenetics or FISH; and/or presence of BCR-ABL fusion transcript identified by RT-PCR b. Hypodiploid with = 44 chromosomes 2. Patients 1 to 20 years of age diagnosed with ALL who do not achieve remission after frontline induction therapy must have one of the features listed below: a. M3 (> 25% blasts) bone marrow status at the end of initial induction therapy b. M2 (5-25% blasts) bone marrow status at the end of initial induction therapy and M2 or M3 bone marrow status at end of consolidation therapy (CCG studies) or at the end of the extended induction phase (POG studies). 3. Patients who are Ph+, hypodiploid with = 44 chromosomes, or M3 at the end of induction therapy must enroll on study within 42 days of initial diagnosis. 4. Patients who are M2 at the end of induction and M2 or M3 at the end of consolidation therapy (CCG) or extended induction therapy (POG) must enroll within 14 days of their last day of frontline therapy Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the feasibility of patient accrual and toxicity of an intensified chemotherapeutic regimen incorporating novel agents for treatment of children and adolescents with VHR ALL.;Secondary Objective: 1. To determine if the BCR-ABL-specific tyrosine kinase inhibitor STI571 can be incorporated into this regimen with acceptable toxicity for patients with Ph+ ALL 2. To compare EFS for VHR patients treated with the intensive chemotherapy with that of historical controls 3. To conduct a preliminary evaluation of the feasibility and efficacy of following intensive reinduction by Hematopoietic Stem Cell Transplantation (HSCT) as therapy for patients with an HLA-matched related donors 4. To determine if MRD assessed at the end of induction and prior to intensification therapy by PCR and flow cytometry can predict relapse 5. To evaluate whether MRD detected by PCR at post-intensification time points is prognostically significant;Primary end point(s): •Feasibility, in terms of toxicity and patient accrual •Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Event-free survival •Feasibility of administering hematopoietic stem cell transplantation after the second consolidation block of chemotherapy •Prognostic effect of minimal residual disease assays | — |
Countries
Australia, Canada, New Zealand, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed