Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies
This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Robert Lowsky
Collaborator:
Information provided by (Responsible Party):
Robert Lowsky, Stanford University
ClinicalTrials.gov Identifier:
NCT01523223
First received: January 27, 2012
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
This phase I 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
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Nasal Type Extranodal NK/T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia 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 Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Relapsing Chronic Myelogenous Leukemia Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia |
Biological: therapeutic allogeneic lymphocytes |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Memory
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Occurence (individual listings and summary) of dose-limiting toxicities [ Time Frame: 60 days following CD8+ memory T-cell infusion ] [ Designated as safety issue: Yes ]
- Incidence of GVHD [ Time Frame: Change from Baseline to 60 days following the CD8+ memory T-cell infusion ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Measured 90 and 180 days following infusion
- Incidence of donor-specific chimerism assessed by STR analysis [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]Measured monthly for 6 months
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (DLI)
Patients undergo CD8+ memory T-cell infusion over 10-20 minutes.
|
Biological: therapeutic allogeneic lymphocytes
Undergo CD8 memory T-cell infusion
Other Name: ALLOLYMPH
|
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 10-20 minutes.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523223
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Robert Lowsky 650-723-0822 rlowsky@stanford.edu | |
| Principal Investigator: Robert Lowsky | |
Sponsors and Collaborators
Robert Lowsky
Investigators
| Principal Investigator: | Robert Lowsky | Stanford University |
More Information
No publications provided
| Responsible Party: | Robert Lowsky, Associate Professor Medicine, Stanford University |
| ClinicalTrials.gov Identifier: | NCT01523223 History of Changes |
| Other Study ID Numbers: | BMT243, NCI-2012-00044, SU-01272012-9028, 22626 |
| Study First Received: | January 27, 2012 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Burkitt Lymphoma Hodgkin Disease Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis |
Waldenstrom Macroglobulinemia Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Mantle-Cell Epstein-Barr Virus Infections Herpesviridae Infections |
ClinicalTrials.gov processed this record on May 16, 2013