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 Information
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, ,
Administrative Informations
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