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Protocol Details

Autologous and Related/Unrelated Allogeneic Hematopoietic Stem Cell Transplant and Cellular Therapies Data Submission and Research Sample Collection to the Center for International Blood and Marrow Transplant Research (CIBMTR) and the National Marrow Donor Program (NMDP)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-C-0053

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 1 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Pregnant Women

Keywords

Cord Blood;
Mobilization;
Allogeneic Hematopoietic;
Stem Cell Therapeutic Outcome;
Demographic Data;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Leukemia;
Neoplasms;
Autologous Stem Cell Transplantation;
Hematopoietic Stem Cell Transplantation;
Lymphoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

- A federal government mandate requires stem cell transplant centers to collect and maintain in a database a minimum of information regarding transplant recipients and their donors.

- The National Marrow Donor Program (NMDP) and the Center for International Blood and Marrow Transplant Research (CIBMTR) maintain an extensive database of medical information on transplant donors and recipients and conducts research using this information.

- Information collected under this study will be submitted to NMDP/CIBMTR in response to the federal mandate.

Objectives:

- To learn more about what makes stem cell transplants work well, such as determining the following:

--how well recipients recover from their transplant

--how recovery after a transplant can be improved

--how access to transplant for different groups of patients can be improved

--how well donors recover from the collection procedures

Eligibility:

- All participants (recipients and their related/unrelated donors) enrolled in an NIH stem cell transplant protocol.

Design:

- Recipients who do not wish to participate and their donors will still have a minimum set of data submitted, as required by law, but the information obtained will not be used in research.

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Eligibility

Eligibility to Participate in the Research Database

Patient Eligibility Criteria:

Any recipient of an unrelated or related allogeneic or autologous HC transplant or cellular therapy whose treatment takes place in a center participating in the CIBMTR is eligible to enroll in the Research Database. This includes adults with and without decision making capacity and children.

Patients with Marrow Toxic Injury Eligibility Criteria:

In the event of a radiation exposure accident, the NMDP has a radiation injury treatment network, whose purpose is to collect data to understand the outcomes of patients treated under these circumstances. Any patient who is treated for a marrow toxic injury at a center participating in the NMDP s Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible patients may have received supportive care only, growth factor support, HC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

All donors registered on the NMDP Registry regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Database.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jennifer S. Wilder, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 3-3121
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3722
jw621w@nih.gov

Tracey N. Chinn, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 3-330
10 Center Drive
Bethesda, Maryland 20892
(301) 592-7220
chinntn@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01166009

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