Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.
PURPOSE: This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens|
- Banking of tumor cells and germline DNA [ Time Frame: length of study ] [ Designated as safety issue: No ]This protocol has no projected closing date. The goal of this study is to maximize banking of ALL specimens at initial and subsequent relapse. This study is a complement to clinical trials for relapsed ALL. While there are no formal accrual goals, accrual and sample quality will be monitored and reviewed twice yearly. If accrual falls below 50 cases/year with at least 80% suitable for cell banking (after a 3-6 month lag period for IRB approval at local centers), then alternative mechanisms may be necessary to achieve study goals
Biospecimen Retention: Samples With DNA
|Study Start Date:||September 2006|
|Estimated Primary Completion Date:||September 2020 (Final data collection date for primary outcome measure)|
Bone marrow (or peripheral blood) is required at the time of diagnosis of relapse. Peripheral blood specimens may be used as follows to supplement or replace BM specimens. If adequate BM samples cannot be obtained; then 5 mL of peripheral blood may be substituted for the required 2 mL of bone marrow as long as the peripheral blood white blood cell count is at least 10,000/μL and there are at least 25% blasts in the peripheral blood.
|Other: biologic sample preservation procedure|
- Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma at first and subsequent relapse.
- Make these specimens available to qualified researchers to study the biology of ALL.
OUTLINE: This is a multicenter study.
Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.
Patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: Not specified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897325
Show 149 Study Locations
|Study Chair:||Stephen P. Hunger, MD||Children's Hospital Colorado Center for Cancer and Blood Disorders|