Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT00534118|
Recruitment Status : Completed
First Posted : September 24, 2007
Results First Posted : August 26, 2020
Last Update Posted : August 26, 2020
RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.
PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: donor lymphocytes||Not Applicable|
- Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.
- Estimate the complete response rate in these patients.
- Assess the toxicity of donor lymphocyte infusion in these patients.
OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cellular Infusions in Patients With Recurrent or Persistent Hematologic Malignancies After Allogeneic Stem Cell Transplant|
|Actual Study Start Date :||October 1, 2003|
|Actual Primary Completion Date :||July 26, 2018|
|Actual Study Completion Date :||July 26, 2018|
Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease
Biological: donor lymphocytes
- Complete Remission Rate [ Time Frame: 100 days post DLI ]continued or induced complete remission after DLI
- Duration of Complete Response in Months (Maximum 12) [ Time Frame: 1 year post DLI ]For participants who achieve a complete remission after DLI, the duration of time until 1) relapse or 2) death in remission or 3) subsequent DLI or 4) last followup (at 1 year after DLI)
- Acute Graft-versus-host Disease [ Time Frame: 100 days post DLI ]development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534118
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Philip L. McCarthy, MD||Roswell Park Cancer Institute|