Status:
COMPLETED
Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 30 years
Brief Summary
This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leuk...
Detailed Description
PRIMARY OBJECTIVES: I. To provide a risk classification scheme for all patients with newly diagnosed acute lymphoblastic leukemia (ALL), which will be used to assign treatment on Children?s Oncology ...
Eligibility Criteria
Inclusion
- Patient has newly diagnosed acute leukemia:
- \> 25% blasts on a bone marrow (BM) aspirate or
- If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy or
- A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic blasts
- Adequate samples must be provided to the reference and/or COG-approved cytogenetics laboratories to allow completion of the studies needed for risk-stratification
- If a BM aspirate is not performed, or adequate material cannot be obtained, peripheral blood (PB) can be substituted for BM if there are at least 1,000 circulating blasts/uL (i.e., a white blood cell \[WBC\] count of 10,000/uL with 10% blasts or a WBC count of 5,000/uL with 20% blasts); if only PB is submitted, please obtain and send twice the volume of PB as the recommended BM volume specified; the patient will remain on AALL08B1 as long as all required central laboratory tests can be successfully performed; as long as there are at least 1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM samples to make sure that adequate material is available to perform the required studies
- If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL clinical trial (there are NO exceptions to this rule)
- Patient has suspected ALL:
- Patients whose blast morphology is obviously myeloid, or whose blasts are myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts with significant expression of multiple lymphoid and myeloid markers such that assignment to a single lineage is not possible) are eligible to enroll in AALL08B1 for cell banking
- Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference Laboratory studies; if informative results needed for treatment stratification are not available at specified time-points during induction, patients will not be eligible to receive post-induction therapy on a COG ALL trial
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion
- 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
Key Trial Info
Start Date :
August 9 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
17463 Patients enrolled
Trial Details
Trial ID
NCT01142427
Start Date
August 9 2010
End Date
September 30 2023
Last Update
October 3 2023
Active Locations (244)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508