Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

Not Applicable

Completed

• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
• Interventions: Biological: donor lymphocytes

• Registration Number: NCT00534118
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.

Secondary

* 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 Timeline

• Study Start: 2003-10-01
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Results First Submitted: 2020-07-29
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-21
• Last Update Submitted: 2020-08-21
• Results First Posted: 2020-08-26
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infusion	donor lymphocytes	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

Primary Outcome Measures

Name	Time	Method
Complete Remission Rate	100 days post DLI	continued or induced complete remission after DLI
Duration of Complete Response in Months (Maximum 12)	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)

Secondary Outcome Measures

Name	Time	Method
Acute Graft-versus-host Disease	100 days post DLI	development of grade III-IV acute graft-versus-host disease (GVHD) per Glucksberg criteria

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States