AALL05B1: A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

Study ID
STU 032011-025

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Alison Patterson
214-456-2726
alison.patterson@childrens.com

Principal Investigator
Tamra Slone

Summary

To collect tissue, bone marrow and peripheral blood samples for patients with relapsed aLL for use to analyze biological factors and to deposit in a cell bank. Samples will be collected according to the table below. These samples will be obtained when other samples are obtained for standard care. These samples can be used for approved projects by laboratory-based investigators.

ReQuiReD SPeCiMenS
Bone marrow ideally 5ml or more (2 ml min.) Study entry
Peripheral blood: if white blood cell count [GreaterThanorequalTo] 10,000/[MiCRo-SYMBoL]L and [GreaterThanorequalTo] 25% blasts present. 5 ml PB can be used to supplement or replace BM specimens above.

oPTionaL SPeCiMenS- highly desired but not required.
Bone marrow ideally 5ml or more (2 ml min.) at the time of any subsequent relapse*
Peripheral blood: if [Less Than] 20% blasts present in peripheral blood at the time of diagnosis of relapse. 5 ml Study entry
Peripheral blood: if [Greater Than] 20% blasts present in peripheral blood at the time of diagnosis of relapse. 5 ml end of the first course of induction therapy**
Pheresate 2 ml or more at time of leukapheresis

*Centers are encourage to send samples at the time of subsequent relapse, should it occur. Samples may be sent at multiple relapses (1st, 2nd, 3rd, etc.).
** as long as there are less then 20% blast in the peripheral blood at this time.

Simple data regarding patient demographics (name, date of birth, gender, race), prior treatment, subsequent treatment and patient outcome will be collected and available for future research. These data will be coded and no patient identifying information will be provided to researchers. Some of this information may already be available through prior participation in CoG trials. The research sample submitted to the CoG Biopathology Center may be labeled with the subject's name, date the sample was drawn, the name of this institution, and the unique identifiers provided by CoG. any cells or Dna given to other scientists for future research tests will not be labeled with any information that could be linked to the subject. information about the subject's disease is linked to the samples in the cell bank, but no personal information will be disclosed to anyone doing research on the samples. only the main offices of the Children's oncology Group will know the name of other information linked to the individual number on the sample of cells.

We would like to collect follow up information for 10 years. The subject can choose to stop taking part in this follow up at any time.

Participant Eligibility

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. No systemic anti-leukemic treatment has been administered for the current relapse. Patients are eligible if they have relapsed while receiving therapy (
* on therapy relapses
* ). Patient must be less than 31 years of age at the time of initial diagnosis of ALL. Adequate bone marrow or peripheral blood specimens must be sent for the patient to be eligible. Specimens for host germline DNA are highly desired, but are optional and are not required for patient eligibility. All patients and/or a parent or legal guardian must sign a written informed consent for collection of biological material, storage in the COG ALL cell bank and for later use of these materials for research. All institutional, FDA, and NCI requirements for human studies must be met. Spanish speaking subjects are eligible to participate in this study.