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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00897325
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Tracking Information
First Submitted Date May 9, 2009
First Posted Date May 12, 2009
Last Update Posted Date January 18, 2020
Actual Study Start Date September 25, 2006
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2016)
Banking of tumor cells and germline DNA [ Time Frame: Not Provided ]
Original Primary Outcome Measures
 (submitted: May 9, 2009)
Banking of tumor cells and germline DNA
Change History Complete list of historical versions of study NCT00897325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
Official Title A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bone marrow, blood
Sampling Method Non-Probability Sample
Study Population Patient has ALL (or a prior history of Non Hodgkin lymphoma) at first or subsequent marrow relapse with greater than or equal to 25% blasts in the bone marrow and/or peripheral blood.
Condition
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Non-Hodgkin Lymphoma
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Non-Hodgkin Lymphoma
Intervention
  • Other: Cytology Specimen Collection Procedure
    Correlative studies
    Other Name: Cytologic Sampling
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 14, 2020)
811
Original Enrollment Not Provided
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Canada,   Puerto Rico,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00897325
Other Study ID Numbers AALL05B1
NCI-2009-00310 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL05B1
CDR0000491159
AALL05B1 ( Other Identifier: Childrens Oncology Group )
AALL05B1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
UG1CA189958 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen P Hunger Children's Oncology Group
PRS Account Children's Oncology Group
Verification Date January 2020