A Children’s Oncology Group pilot study for the treatment of very high risk acute lymphoblastic leukemia in children and adolescents

• Conditions: Acute lymphoblastic leukemia; MedDRA 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]

• Registration Number: EUCTR2012-001477-82-Outside-EU/EEA
• Lead Sponsor: Children's Oncology Group (COG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-16
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 160

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

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified