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
Last Update Posted : November 9, 2018
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
- Determine if response rate exceeds 10% [ Time Frame: Every 2 weeks ]
- Estimate the complete Response rate [ Time Frame: Every 2 weeks ]
- Duration of response [ Time Frame: Every 2 weeks ]
- Assess toxicity of cellular therapy [ Time Frame: Every 2 weeks ]
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|