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Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Lowsky, Stanford University Identifier:
First received: January 27, 2012
Last updated: November 17, 2016
Last verified: July 2016
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: 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:
  • Occurrence (individual listings and summary) of dose-limiting toxicities [ Time Frame: 60 days following CD8+ memory T-cell infusion ]
  • Incidence of GVHD [ Time Frame: Change from Baseline to 60 days following the CD8+ memory T-cell infusion ]

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 ]
    Measured 90 and 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

Enrollment: 16
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: September 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

Detailed Description:


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).


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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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
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Please refer to this study by its identifier: NCT01523223

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Robert Lowsky
National Cancer Institute (NCI)
Principal Investigator: Robert Lowsky Stanford University
  More Information

Responsible Party: Robert Lowsky, Associate Professor Medicine, Stanford University Identifier: NCT01523223     History of Changes
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 )
Study First Received: January 27, 2012
Last Updated: November 17, 2016

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hodgkin Disease
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Lymphoma, T-Cell
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Waldenstrom Macroglobulinemia
Lymphomatoid Granulomatosis
Lymphoma, Extranodal NK-T-Cell
Lymphoma, T-Cell, Peripheral
Intraocular Lymphoma processed this record on April 27, 2017