CompletedPhase 2

Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders

United States25 participantsStarted 2002-12

Plain-language summary

Allogeneic stem cell transplantation may provide long-term remissions for some patients with hematological malignancies. However, allogeneic transplantation is associated with a significant risk of potentially life threatening complications due to the effects of chemotherapy and radiation on the body and the risks of serious infection. In addition, patients may develop a condition called Graft versus host disease that arises from an inflammatory reaction of the donor cells against the recipient's normal tissues. The risk of graft versus host disease is somewhat increased in patients who are receiving a transplant from an unrelated donor. One approach to reduce the toxicity of allogeneic transplantation is a strategy call nonmyeloablative or "mini" transplants. In this approach, patients receive a lower dose of chemotherapy in an effort to limit treatment related side effects. Patients undergoing this kind of transplant remain at risk for graft versus host disease particularly if they receive a transplant from an unrelated donor. The purpose of this research study is to examine the ability of a drug called CAMPATH-1H to reduce the risk of graft versus host disease and make transplantation safer. CAMPATH-1H binds to and eliminates cells in the system such as T cells that can cause graft versus host disease (GvHD). As a result, earlier studies have shown that patients who receive CAMPATH-1H with an allogeneic transplant have a lower risk of GvHD. In the present study, we will examine the impact of treatment with CAMPATH-1H as part of an allogeneic transplant on the development of GvHD and infection. In addition, we will study the effects of CAMPATH-1H on the immune system by testing blood samples in the laboratory.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age less than 65 years. There is no lower age limit. Patients 65 years and older will be accrued on a case-by-case basis to this protocol, after discussion and approval by the principal investigator. The acceptance to this protocol for such patients would be based on the absence of coexisting medical problems, which would seriously compromise the patient's ability to tolerate the known morbidity and risks of bone marrow transplantation. * Patients must have a 5/6 or 6/6 HLA matched, unrelated donor of bone marrow stem cells. * Each patient must be willing to participate as a research subject and must sign an informed consent form after having been advised as to the nature and risk of the study prior to entering the protocol. Parents or legal guardians of patients who are minors will sign the informed consent form after being advised of the nature and risks of the study. Attending physicians in the Bone Marrow Transplant Service will enroll patients to this study and will obtain written consents. Eligibility Criteria - Donor * 5/6 or 6/6 HLA matched with the recipient as determined by molecular testing. Donors will be identified through the National Marrow Donor Program for unrelated donors. * Donor selection will be performed as outlined in the donor selection SOP's. In patients who have more than one potential donor preference will be given to donors who have no evidence of CMV exposure (if the recipient is CMV-), those who are younger and those who …

What they're measuring

Primary objective of study is to determine the safety of non-myeloablative allogenic stem cell transplantation from matched unrelated donors in patients with hematologic malignancies with a focus on the incidence of treatment-related mortality.

Timeframe: Within 100 days of transplant

Trial details

NCT IDNCT00533923

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-01