Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10003939Term: B-lymphoblastic lymphoma (Kiel Classification)System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

• Registration Number: EUCTR2011-003430-13-IE
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-10
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9483

Inclusion Criteria

• Patients must be enrolled on the classification study AALL08B1 prior to treatment and enrollment on AALL0932 (except for B-LLy patients who are not eligible for AALL08B1).
• B-ALL patients must be >365 days and <10 years of age. B-LLy patients must be >365 days and =<30.99 years of age.
• B-ALL patients must have an initial white blood cell count <50000/µL.
• Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stage I or II. Patients with Down syndrome are also eligible.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

• Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed previously, with the exception of steroid pretreatment and intrathecal cytarabine.
• Patients with CNS3 positive disease.
• B-ALL patients with testicular leukemia.
• B-LLy patients with
- T-lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
- M2 (5%-25% blasts) or M3 (>25% blasts) marrow.

Study & Design

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