Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Brief Title

Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Official Title

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Brief Summary

      The purpose of this study is to provide allogeneic stem cell transplantation to patients who
      have not traditionally undergone this procedure because of it high incidence of treatment
      related side effects. We hope to decrease these side effects by decreasing the chemotherapy
      dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone
      marrow is not completely eliminated) and by using donated stem cells to treat cancer of the
      blood.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

durable engraftment

Secondary Outcome

 disease free survival and overall survival

Condition

AML

Intervention

Cyclophosphamide

Study Arms / Comparison Groups

 1

Description:  Study treatment arm with G-CSF

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

July 1999

Primary Completion Date

March 2006

Eligibility Criteria

        Inclusion Criteria - Patient:

          -  AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED
             NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma,
             MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET

          -  Age less than 65 years

          -  Patients must have a healthy family member who is HLA-identical to the recipient or
             has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4
             daily leukaphereses

          -  Each patient must sign an informed consent and be willing to participate as a research
             subject after having been advised of the nature and risk of the study prior to
             entering protocol

        Inclusion Criteria - Donor:

          -  Absence of hematologic or marrow function related diseases that interferes with the
             collection of sufficient numbers of normal progenitor cells

          -  Absence of any medical condition that would pose a serious health risk by undergoing
             peripheral blood stem cell harvest

          -  Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C

          -  The donor must be blood relation. A prospective related donor must be at least
             genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

        Exclusion Criteria - Patient:

          -  Active CNS involvement

          -  Females who are pregnant or breast feeding

          -  ECOG performance status > 1. Karnofsky performance status < 80%

          -  LVEF < 40%

          -  Active viral, bacterial, or fungal infection

          -  Patients seropositive for HIV; HTLV -1

          -  Patients not providing informed consent

          -  Patients with known hypersensitivity to E. Coli derived product

        Exclusion Criteria - Donor:

          -  A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral
             hepatitis infection. Presence of any medical condition that would pose a serious
             health risk by undergoing peripheral blood stem cell harvest. Donors with known
             hypersensitivity to E. Coli derived products.
      

Gender

All

Ages

N/A - 65 Years

Accepts Healthy Volunteers

No

Contacts

David F McDermott, MD, , 

NCT ID

NCT00636909

Organization ID

2001P002293

Secondary IDs

W-99-0234-FB

Responsible Party

Principal Investigator

Study Sponsor

Beth Israel Deaconess Medical Center

Collaborators

 Amgen

Study Sponsor

David F McDermott, MD, Principal Investigator, Beth Israel Deaconess Medical Center

Verification Date

April 2017