Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies

Not Recruiting

Trial ID: NCT01523223

Purpose

This phase 1 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

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

Stanford Investigator(s)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Eligibility


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

Intervention(s):

biological: therapeutic allogeneic lymphocytes

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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