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

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ClinicalTrials.gov Identifier: NCT00533923
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : July 18, 2016
Information provided by (Responsible Party):
David McDermott, Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
AML ALL CLL Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Aplastic Anemia Myeloproliferative Disorder Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders
Study Start Date : December 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Intervention Details:
  • Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF
    Other Names:
    • Cytoxan;
    • Fludara;
    • Leukine;

Primary Outcome Measures :
  1. 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. [ Time Frame: Within 100 days of transplant ]

Secondary Outcome Measures :
  1. Secondary clinical endpoints includes; incidence of graft failure or rejection; incidence and severity of acute and chronic GVHD; tumor response, and long-term overall and disease-free survival. [ Time Frame: Within 100 days of transplant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 are male. Selection of an unrelated donor from the NMDP registry will proceed according to the donor selection SOP. Molecular testing of HLA-A, B, and DR alleles will identify potential donors and the American Red Cross HLA lab will confirm all typing. Donor selection will be coordinated with transplant physician and the HLA laboratory director. Preference will be given to donors who are 6/6 molecular matches, those who are CMV- (if the recipient is CMV-), those who are younger, and males.

Exclusion Criteria:

  • Active CNS leukemia involvement.
  • Female patients who are pregnant or breast feeding
  • Karnofsky performance status < 70%, (appendix 1).
  • Left ventricular ejection fraction of < 40%.
  • Serum creatinine > 1.5 X normal
  • Patients seropositive for HIV; HTLV -1, or with evidence of chronic active hepatitis as demonstrated by detection of hepatitis surface antigen in the serum
  • Patients with serologic evidence of hepatitis B or C exposure will undergo liver biopsy to assess for presence of active hepatitis or fibrosis and quantification of risk of proceeding with transplant
  • Patients not providing informed consent.
  • Patients with known hypersensitivity to E. Coli derived products.
  • SGOT and SGPT > 2.5 x ULN, unless thought to be disease related
  • Total bilirubin > 2.0 mg/dl, with direct bilirubin > 0.5 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533923

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Principal Investigator: David F McDermott, MD Beth Israel Deaconess Medical Center
Study Director: David E Avigan, MD Beth Israel Deaconess Medical Center
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Responsible Party: David McDermott, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00533923    
Other Study ID Numbers: 2002P000219
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by David McDermott, Beth Israel Deaconess Medical Center:
Nonmyeloablative Allogeneic Stem Cell Transplantation
Myelodysplastic syndrome
Relapsed non-Hodgkin's or Hodgkin's lymphoma
Relapsed multiple myeloma
Aplastic anemia
Myeloproliferative disorder
Fludarabine (FLUDARA)
AML in first remission, first relapse or subsequent remission
ALL in first relapse, second or subsequent remission
ALL in first remission, in a high-risk category
Aplastic anemia characterized by ANC< 1000 and/or platelets < 30 without transfusional support
Myeloproliferative disorder (P Vera, CMML, ET)
Additional relevant MeSH terms:
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Multiple Myeloma
Hodgkin Disease
Myelodysplastic Syndromes
Anemia, Aplastic
Myeloproliferative Disorders
Hematologic Diseases
Pathologic Processes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Bone Marrow Failure Disorders