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

January 27, 2012
December 6, 2012
January 2012
March 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01523223 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Undergo CD8 memory T-cell infusion
Other Name: ALLOLYMPH
Experimental: Treatment (DLI)
Patients undergo CD8+ memory T-cell infusion over 10-20 minutes.
Intervention: Biological: therapeutic allogeneic lymphocytes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
Not Provided
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
United States
 
NCT01523223
BMT243, NCI-2012-00044, SU-01272012-9028, 22626
Yes
Robert Lowsky, Stanford University
Robert Lowsky
National Cancer Institute (NCI)
Principal Investigator: Robert Lowsky Stanford University
Stanford University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP