Protocol

HAP3R: T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus NK Cell Transplantation in Patients with Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Diseases

Stem Cell / Bone Marrow Transplant : Relapsed or refractory hematologic malignancies

Description

This study is for patients with blood cell cancer that is difficult to treat even after very intensive therapy. At this time, the cancer has either 1) come back (relapsed) or, 2) not responded well (refractory) after a previous allogeneic stem cell transplant. In this situation, the chances of curing disease with regular chemotherapy are extremely low, and the chances of cure with another transplant are only slightly higher. Repeat transplant may not work because the patient will be more likely to develop side effects of the therapy, some of which may be fatal (cause death). 

In addition, the cancer cells may not respond to this treatment. The study team is proposing to treat the patient with an allogeneic stem cell transplant. (An allogeneic stem cell transplant means that the blood stem cells used for the transplant are obtained from someone other than the patient.) This therapy is for patients who have already had an allogeneic stem cell transplant and may benefit from another.

Standard stem cell transplantation starts with giving chemotherapy medications to damage or kill the patient’s bone marrow. Bone marrow is mostly located in the larger bones of the body like the hips and the leg bones. By damaging or killing a patient’s bone marrow, room is made within the bones – called the “bone marrow space.” The patient then gets stem cells from the bone marrow of another person called the “donor.” 

Donor stem cells are needed in order to restore and “rebuild” the patient’s bone marrow that has been damaged from the chemotherapy and to help give the patient new bone marrow and, in turn, a healthy immune and blood cell forming systems. The donor stem cells (called “the graft”) travel through the patient’s blood to the bone marrow space and begin to grow and make new blood cells. Giving (infusing) the stem cell graft to the patient is called “a stem cell transplant.”The best type of donor for a stem cell transplant is a brother or sister who is a "match" for the patient's immune type (HLA type).

In this study, blood stem cells will be obtained from a haploidentical donor. Stem cells from a haploidentical donor will not be as closely matched as those from a matched brother or a sister or from a matched unrelated volunteer. As a result, there may be a higher chance of problems related to the stem cell transplant. Such problems include failure of the donor cells to grow (graft failure), and a condition called graft-versus-host disease (GVHD). GVHD occurs when the donor cells (the graft) recognize that the body tissues of the patient (the host) are different. Severe GVHD can be life threatening.


Objectives


Eligibility

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact

Brandon M. Triplett, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.