EUCTR2011-003430-13-IE
Active, Not Recruiting
Phase 1
Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)
ConditionsAcute Lymphoblastic Leukemia and Lymphoblastic LymphomaMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10003939Term: B-lymphoblastic lymphoma (Kiel Classification)System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- Sponsor
- Children's Oncology Group
- Enrollment
- 9483
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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