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 April 2016 by Children's Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00897325
First received: May 9, 2009
Last updated: April 7, 2016
Last verified: April 2016
  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. 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.

Condition Intervention
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Non-Hodgkin Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Non-Hodgkin Lymphoma
Other: Cytology Specimen Collection Procedure
Other: Laboratory Biomarker Analysis

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: Not Provided ] [ Designated as safety issue: No ]

Estimated Enrollment: 528
Study Start Date: September 2006
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (Collecting and banking ALL specimens)
Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.
Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) at first and subsequent relapse.

II. 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.

  Eligibility

Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly diagnosed with acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma.
Criteria

Inclusion Criteria:

  • 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
  • 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 180 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Hunger Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00897325     History of Changes
Other Study ID Numbers: AALL05B1  NCI-2009-00310  COG-AALL05B1  CDR0000491159  AALL05B1  AALL05B1  U10CA098543 
Study First Received: May 9, 2009
Last Updated: April 7, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 25, 2016