EUCTR2012-001477-82-Outside-EU/EEA
Active, not recruiting
Not Applicable
A Children’s Oncology Group pilot study for the treatment of very high risk acute lymphoblastic leukemia in children and adolescents - COGAALL0031
Children's Oncology Group (COG)0 sites160 target enrollmentMarch 16, 2012
ConditionsAcute lymphoblastic leukemiaMedDRA version: 14.1Level: LLTClassification code 10024338Term: Leukemia lymphoblastic acuteSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGlivec/ Gleevec
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute lymphoblastic leukemia
- Sponsor
- Children's Oncology Group (COG)
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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