Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant
|ClinicalTrials.gov Identifier: NCT00534118|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2007
Last Update Posted : January 4, 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|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: donor lymphocytes|
- 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|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||April 30, 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 ]
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|