Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies
A Phase I Study of CD8 Memory T-Cell Donor Lymphocyte Infusion for Relapse of Hematolymphoid Malignancies Following Matched Related Donor Allogeneic Hematopoietic Cell Transplantation
4 other identifiers
interventional
16
1 country
1
Brief Summary
This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-cancer effects). 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 below P25 for phase_1
Started Jan 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 27, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 22, 2023
July 1, 2016
4.7 years
January 27, 2012
November 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Occurrence (individual listings and summary) of dose-limiting toxicities
60 days following CD8+ memory T-cell infusion
Incidence of GVHD
Change from Baseline to 60 days following the CD8+ memory T-cell infusion
Secondary Outcomes (2)
Disease response as assessed by complete remission, partial remission, stable disease, and progressive disease from radiographic and cellular or tissue samples
Change from baseline to 180 days following infusion
Incidence of donor-specific chimerism assessed by STR analysis
Change from baseline to 6 months
Study Arms (1)
Treatment (DLI)
EXPERIMENTALPatients undergo CD8+ memory T-cell infusion over 10-20 minutes.
Interventions
Undergo CD8 memory T-cell infusion
Eligibility Criteria
You may qualify if:
- Patients must have undergone a human leukocyte antigen (HLA) matched (sibling) allogeneic HCT for a hematologic or lymphoid malignancy other than chronic myelogenous leukemia (CML) who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1x10\^8cells/kg will be eligible for CD8+ memory T cell infusion
- Patients must have no evidence of active graft-versus-host disease and must be on a stable immunosuppressive regimen without a change in drugs dosage in the 4 weeks prior to the planned CD8+ memory T cell infusion
- Patients must not have any active infections
- Patients must have a performance status of \> 70% on the Karnofsky scale
- Serum creatinine of \< 2 mg/dl or creatinine clearance of \> 50 cc/min
- Bilirubin of \< 3 mg/dl Transaminases \< 3 times the upper limit of normal
- Patients must have negative antibody serology for the human immunodeficiency virus (HIV1 and 2) and hepatitis C virus and negative test for hepatitis B surface antigen
- DONOR:
- Donors must be an HLA matched sibling
- Donors must be 18-75 years of age, inclusive
- Donors must be in a state of general good health
- Donors must have a white blood cell count \> 3.5 x 10\^9/liter DONOR: Platelets \> 150 x 10\^9/liter
- Donors: Hematocrit \> 35%
- Donors must be capable of undergoing leukapheresis
- Donors must not be seropositive for HIV 1 and 2, Hepatitis B surface antigen, Hepatitis B core antibody, Hepatitis C antibody, human T-lymphotropic virus (HTLV) antibody, cytomegalovirus (CMV) immunoglobulin (Ig)M, or Rapid Plasma Reagin (RPR) (Treponema)
- +1 more criteria
You may not qualify if:
- Diagnosis of CML except patients who have failed prior donor leukocyte infusion with a minimum cell dose of 1x10\^8 cells/kg
- Patients who have been diagnosed with a second cancer (except carcinoma in situ of the cervix and basal cell carcinoma of the skin) which is currently active or has been treated within three years prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Lowskylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
Related Publications (1)
Muffly L, Sheehan K, Armstrong R, Jensen K, Tate K, Rezvani AR, Miklos D, Arai S, Shizuru J, Johnston L, Meyer E, Weng WK, Laport GG, Negrin RS, Strober S, Lowsky R. Infusion of donor-derived CD8+ memory T cells for relapse following allogeneic hematopoietic cell transplantation. Blood Adv. 2018 Mar 27;2(6):681-690. doi: 10.1182/bloodadvances.2017012104.
PMID: 29572391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Lowsky
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor Medicine
Study Record Dates
First Submitted
January 27, 2012
First Posted
February 1, 2012
Study Start
January 1, 2012
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
November 22, 2023
Record last verified: 2016-07