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Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Stanford University
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Intraocular Lymphoma
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Extranodal NK-T-Cell
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphomatoid Granulomatosis
Mycosis Fungoides
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Sezary Syndrome
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 24, 2014