- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523223
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
Study Overview
Status
Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Splenic Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Peripheral T-cell Lymphoma
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Relapsing Chronic Myelogenous Leukemia
- Refractory Chronic Lymphocytic Leukemia
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Extranodal Marginal Zone B-cell Lymphoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- Female donors must not be pregnant or lactating
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (DLI)
Patients undergo CD8+ memory T-cell infusion over 10-20 minutes.
|
Undergo CD8 memory T-cell infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence (individual listings and summary) of dose-limiting toxicities
Time Frame: 60 days following CD8+ memory T-cell infusion
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60 days following CD8+ memory T-cell infusion
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Incidence of GVHD
Time Frame: Change from Baseline to 60 days following the CD8+ memory T-cell infusion
|
Change from Baseline to 60 days following the CD8+ memory T-cell infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease response as assessed by complete remission, partial remission, stable disease, and progressive disease from radiographic and cellular or tissue samples
Time Frame: Change from baseline to 180 days following infusion
|
Measured 90 and 180 days following infusion
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Change from baseline to 180 days following infusion
|
Incidence of donor-specific chimerism assessed by STR analysis
Time Frame: Change from baseline to 6 months
|
Measured monthly for 6 months
|
Change from baseline to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Lowsky, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Virus Diseases
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Bacterial Infections and Mycoses
- Tumor Virus Infections
- Neoplasms, Plasma Cell
- Precancerous Conditions
- Leukemia, Lymphoid
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Eye Neoplasms
- Chronic Disease
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Recurrence
- Lymphoma, Non-Hodgkin
- Mycoses
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Lymphoma, B-Cell, Marginal Zone
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Lymphoma, T-Cell, Cutaneous
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Mycosis Fungoides
- Sezary Syndrome
- Lymphomatoid Granulomatosis
- Lymphoma, Extranodal NK-T-Cell
- Intraocular Lymphoma
Other Study ID Numbers
- BMT243
- NCI-2012-00044 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SU-01272012-9028 (Other Identifier: Stanford University)
- 22626 (Other Identifier: Stanford IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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