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
  Purpose

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.


Condition Intervention
Leukemia
Lymphoma
Other: biologic sample preservation procedure

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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

Bone marrow, blood


Estimated Enrollment: 1000
Study Start Date: September 2006
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: biologic sample preservation procedure

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897325

  Show 149 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Stephen P. Hunger, MD Children's Hospital Colorado Center for Cancer and Blood Disorders
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00897325     History of Changes
Other Study ID Numbers: AALL05B1, COG-AALL05B1, CDR0000491159
Study First Received: May 9, 2009
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
recurrent adult acute lymphoblastic leukemia
recurrent adult non-Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood non-Hodgkin lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014