Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders (MINI HEME)

Beth Israel Lahey Health

Status and phase

Completed

Phase 2

Conditions

AML

CML Chronic Phase, Accelerated Phase, or Blast Crisis

APLASTIC ANEMIA

MDS

CLL

RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA

ALL

MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)

MULTIPLE MYELOMA

Treatments

Drug: fludarabine

Drug: methotrexate

Biological: G-CSF

Drug: Cyclophosphamide

Drug: cyclosporine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00636909

W-99-0234-FB

2001P002293

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.