Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
2 other identifiers
interventional
77
1 country
1
Brief Summary
This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2013
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
August 7, 2019
CompletedAugust 7, 2019
June 1, 2019
5.3 years
April 22, 2013
June 12, 2019
July 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
Up to 2 years
Secondary Outcomes (5)
Progression Free Survival (PFS)
2 years
Overall Survival (OS)
At 2 years
Rate of Acute GVHD (aGVHD) With Any Grade
At 1 year and 2 year
Rate of Chronic GVHD (cGVHD)
At 1 year and 2 year
Treatment-related Mortality
At 2 year
Study Arms (1)
Treatment (DLI)
EXPERIMENTALPatients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- The clinical trial will be offered to all high risk (defined 3 below) patients with hematologic malignancies who require stem cell transplants as part of their standard of care using matched related or unrelated donors
- Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
- Refractory acute myelogenous or lymphoid leukemia
- Relapsed acute myelogenous or lymphoid leukemia
- Myelodysplastic syndromes with 5% or more blasts
- Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
- Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
- High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
- DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
- T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30 mg of alemtuzumab total in the conditioning regimen
- Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
- Zubrod performance status (PS) 0-2 or equivalent Karnofsky PS
- Eligible for allogeneic transplant in the treating physicians' judgment and by institutional standards
- ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
- Donor lymphocytes available or able to be collected
- +7 more criteria
You may not qualify if:
- Pregnant or lactating females
- Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C virus
- Human immune deficiency virus
- Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent
- Creatinine \>= 2.0 mg/dL
- SGOT and SGPT \>= 5 x ULN; liver biopsy preferred for such patients
- Bilirubin \>= 3 x ULN (unless Gilbert's syndrome)
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% corrected for hemoglobin
- Left ventricular ejection fraction or shortening fraction \< 40%
- Unlikely to be able to procure additional donor lymphocytes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Hongtao Liu
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Hongtao Liu
University of Chicago Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 25, 2013
Study Start
April 4, 2013
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 7, 2019
Results First Posted
August 7, 2019
Record last verified: 2019-06