Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

NCT ID: NCT00636909

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31

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.

Conditions

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Study treatment arm with G-CSF

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

preparative cytoreduction

fludarabine

Intervention Type: DRUG

preparative cytoreduction

cyclosporine

Intervention Type: DRUG

immunosuppressive therapy

methotrexate

Intervention Type: DRUG

immunosuppressive therapy

G-CSF

Intervention Type: BIOLOGICAL

foster engraftment

Interventions

Cyclophosphamide

preparative cytoreduction

Intervention Type: DRUG

fludarabine

preparative cytoreduction

Intervention Type: DRUG

cyclosporine

immunosuppressive therapy

Intervention Type: DRUG

methotrexate

immunosuppressive therapy

Intervention Type: DRUG

G-CSF

foster engraftment

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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.

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David McDermott

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David F McDermott, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

David E Avigan, MD

Role: STUDY_DIRECTOR

Beth Israel Deaconess Medical Center

Other Identifiers

W-99-0234-FB

Identifier Type: -

Identifier Source: secondary_id

2001P002293

Identifier Type: -

Identifier Source: org_study_id