Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies
NCT ID: NCT01523223
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2012-01-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the feasibility of purifying allogeneic CD8+ memory T-cells suitable for clinical application and to determine the safety and maximum tolerated dose (MTD) of these cells in patients with recurrent or refractory hematolymphoid malignancies following allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
I. To determine disease response, time to disease progression, event-free survival, and overall survival following treatment with allogeneic CD8+ memory T-cells.
II. To assess donor specific chimerism before and at designated time points after treatment with allogeneic CD8+ memory T-cells.
OUTLINE: This is a dose-escalation study.
Patients undergo CD8+ memory T-cell infusion over 10 to 20 minutes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (DLI)
Patients undergo CD8+ memory T-cell infusion over 10-20 minutes.
therapeutic allogeneic lymphocytes
Undergo CD8 memory T-cell infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
therapeutic allogeneic lymphocytes
Undergo CD8 memory T-cell infusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* Female donors must not be pregnant or lactating
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Robert Lowsky
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Lowsky
Associate Professor Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Lowsky
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-00044
Identifier Type: REGISTRY
Identifier Source: secondary_id
SU-01272012-9028
Identifier Type: OTHER
Identifier Source: secondary_id
22626
Identifier Type: OTHER
Identifier Source: secondary_id
BMT243
Identifier Type: -
Identifier Source: org_study_id