MINI HEME: Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00636909

Collaborator

Amgen (Industry)

Enrollment

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	Drug: Cyclophosphamide Drug: fludarabine Drug: cyclosporine Drug: methotrexate Biological: G-CSF	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders

Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Study treatment arm with G-CSF	Drug: Cyclophosphamide preparative cytoreduction Drug: fludarabine preparative cytoreduction Drug: cyclosporine immunosuppressive therapy Drug: methotrexate immunosuppressive therapy Biological: G-CSF foster engraftment

Arm

Intervention/Treatment

Experimental: 1

Study treatment arm with G-CSF

Drug: Cyclophosphamide

preparative cytoreduction

Drug: fludarabine

preparative cytoreduction

Drug: cyclosporine

immunosuppressive therapy

Drug: methotrexate

immunosuppressive therapy

Biological: G-CSF

foster engraftment

Outcome Measures

Primary Outcome Measures

durable engraftment [100 days]
hematopoeitic reconstitution [3 years]
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells [3 years]

Secondary Outcome Measures

disease free survival and overall survival [3 years]
incidence of treatment related toxicity and acute and chronic graft versus host disease [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Beth Israel Deaconess Medical Center
Amgen

Investigators

Principal Investigator: David F McDermott, MD, Beth Israel Deaconess Medical Center
Study Director: David E Avigan, MD, Beth Israel Deaconess Medical Center