Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00897325
First received: May 9, 2009
Last updated: August 5, 2014
Last verified: August 2014

May 9, 2009
August 5, 2014
September 2006
September 2020   (final data collection date for primary outcome measure)
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
Banking of tumor cells and germline DNA [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897325 on ClinicalTrials.gov Archive Site
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Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

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.

OBJECTIVES:

  • 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Bone marrow, blood

Non-Probability Sample

Patients with relapsed ALL or prior history of non-Hodgkin lymphoma

  • Leukemia
  • Lymphoma
Other: biologic sample preservation procedure
All patients
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.
Intervention: Other: biologic sample preservation procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
September 2020   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma
  • In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood
  • Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No concurrent systemic antileukemic treatment administered for current relapse

    • Intrathecal chemotherapy allowed
    • On-therapy relapse allowed
Both
up to 30 Years
No
United States,   Canada,   Australia,   Switzerland
 
NCT00897325
AALL05B1, COG-AALL05B1, CDR0000491159
Yes
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Stephen P. Hunger, MD Children's Hospital Colorado Center for Cancer and Blood Disorders
Children's Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP