Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Phase 1

• Conditions: Acute Lymphoblastic Leukemia; MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004773-27-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: 2014-01-10
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17230

Inclusion Criteria

•Newly diagnosed acute leukemia meeting one of the following criteria:
>25% blasts by bone marrow aspirate
or Acute leukemia diagnosed by bone marrow biopsy
or Complete blood count with documented leukemia blasts of = 1,000/µL
•Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification.
•Patients with suspected acute lymphoblastic leukemia (ALL)
•Patient must be <31 years of age at diagnosis of acute leukemia.
•Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies as per Section 4.1 so that the data needed for risk-adjusted post-Induction therapy are available.

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

•Patient must not have received prior cytotoxic therapy except for steroids or intrathecal Chemotherapy
•Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy.
•All patients and/or their parents or legal guardian must sign a written informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG) frontline specific-treatment studies.<br>•To capture classification data for correlative studies accompanying current COG ALL treatment protocols.<br>•To provide a central reference guide for all required and research studies that will be conducted in local and reference laboratories for all newly diagnosed ALL patients.;Secondary Objective: •To provide a mechanism for optional banking of leukemia and germline specimens for current and future research.;Primary end point(s): per AALL0932 or AALL1131 or another applicable therapeutic COG protocol;Timepoint(s) of evaluation of this end point: per AALL0932 or AALL1131 or another applicable therapeutic COG protocol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): per AALL0932 or AALL1131 or another applicable therapeutic COG protocol;Timepoint(s) of evaluation of this end point: per AALL0932 or AALL1131 or another applicable therapeutic COG protocol