Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

Summary

The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Biphenotypic Leukemia
• Acute Lymphocytic Leukemia
• Chronic Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Plasma Cell Neoplasms
• Lymphoma
• Hodgkin's Disease
• Aplastic Anemia

Interventions

RADIATION

Total Body Irradiation (TBI)

Total body irradiation is given in 8 fractions over 4 days (total dose of 12 Gy).

BIOLOGICAL

Donor Lymphocyte Infusion (DLI)

After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.

DRUG

Cyclophosphamide

Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days

DRUG

Mycophenolate Mofetil (MMF)

Started the day before the transplant to prevent graft versus host disease (GVHD)

DRUG

Tacrolimus

Started the day before the transplant to prevent graft-versus-host disease (GVHD)

DEVICE

Hematopoietic stem cell transplantation (HSCT)

One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-donor stem cell product. This is the day of transplant. The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem and progenitor cells in human allogeneic hematopoietic stem cell transplantation.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

  lead OTHER

Principal Investigators

• Dolores Grosso, DNP, CRNP · Thomas Jefferson University

• Neal Flomenberg, MD · Thomas Jefferson University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2013-05-31

Completion

2014-05-31

Countries

• United States

Study Locations