Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps

Summary

This is a research study involving the treatment of patients with hematological cancers with allogeneic (cells from a donor) hematopoietic stem cell transplant (HSCT). HSCT is often referred to as bone marrow transplant. Patients who are not expected to have long term survival after conventional therapy will undergo HSCT as a curative therapy after receiving front line therapy for their disease. This project is based on an HSCT approach that has been used at TJU since 2006 with the goal of optimizing this type of treatment further. In this new study, the investigators will substitute the chemotherapy agent, Melphalan (Mel), for cyclophosphamide (CY). Cyclophosphamide was used in the original trial. The research question is whether side effects are less using Mel and if donor T cells can be made tolerant to the recipient with the use of Mel. The proposed study is also more specific in terms of performance status and organ function entry criterion. The investigators observed in the original trial that patients with poor performance upon admission for transplant did not have as good outcomes.

Because many older patients are treated according to this type of transplant, the chemotherapy and radiation used are less intensive than other types of transplant. The name for this in the transplant field is a reduced intensity hematopoietic stem cell transplant. The abbreviations most used in this document are RIC for reduced intensity conditioning, HSCT which refers to the transplant itself, and MEL which refers to the drug, Melphalan.

Conditions

• Hematologic Malignancies
• Acute Leukemia
• Myelodysplastic Syndromes (MDS) Other Than RA or RARS Subtypes
• Hodgkin's Lymphoma
• Non-Hodgkin's Lymphoma
• Myeloma
• Chronic Myelogenous (or Myeloid) Leukemia (CML) Resistant to STI Therapy

Interventions

DRUG

Fludarabine

Part of the conditioning regimen

DRUG

Thiotepa

Part of the conditioning regimen

RADIATION

Total Body Irradiation (TBI)

There is one fraction of total body irradiation (2Gy) as part of the conditioning regimen.

BIOLOGICAL

Donor Lymphocyte Infusion (DLI)

Immediately following the conditioning regimen of fludarabine, thiotepa, and TBI, the patient receives a set dose of their donor's T cells (DLI), After the DLI, the donor's T cells will react with the remaining parts of the recipients immune system.

DRUG

Melphalan

Two days after the DLI, Melphalan will be given to eliminate the reacting T cells to avoid graft versus host disease. Non-activated T cells should not be affected by the Melphalan and remain to help fight infection.

DEVICE

Hematopoietic stem cell transplantation (HSCT)

One day after the Melphalan ends, the patient will receive their donor's stem cells. This is the actual 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

2011-04-30

Primary Completion

2012-05-31

Completion

2012-08-31

Countries

• United States

Study Locations