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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 October 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: October 14, 2016
Last verified: October 2016

May 9, 2009
October 14, 2016
September 2006
January 2100   (final data collection date for primary outcome measure)
Banking of tumor cells and germline DNA [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
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
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients newly diagnosed with acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma.
  • 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
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
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.
Interventions:
  • Other: Cytology Specimen Collection Procedure
  • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
528
Not Provided
January 2100   (final data collection date for primary outcome measure)

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
Both
up to 30 Years   (Child, Adult)
No
United States,   Australia,   Canada,   Puerto Rico,   Switzerland
 
NCT00897325
AALL05B1, NCI-2009-00310, COG-AALL05B1, CDR0000491159, AALL05B1, AALL05B1, U10CA098543
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Stephen Hunger Children's Oncology Group
Children's Oncology Group
October 2016

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