Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00636909
• Date of registration: 10/03/2008
• Prospective Registration: No
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders MINI HEME
• Scientific title: Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
• Date of first enrolment: July 1999
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00636909
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Contacts

• Name: David E Avigan, MD
• Affiliation: Beth Israel Deaconess Medical Center

• Name: David F McDermott, MD
• Affiliation: Beth Israel Deaconess Medical Center

Key inclusion & 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.



Age minimum: N/A
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

MULTIPLE MYELOMA

MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)

ALL

RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA

MDS

AML

CLL

CML Chronic Phase, Accelerated Phase, or Blast Crisis

APLASTIC ANEMIA

Intervention(s)

Drug: fludarabine

Drug: cyclosporine

Drug: methotrexate

Biological: G-CSF

Drug: Cyclophosphamide

Primary Outcome(s)

durable engraftment [Time Frame: 100 days]

evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells [Time Frame: 3 years]

hematopoeitic reconstitution [Time Frame: 3 years]

Secondary Outcome(s)

disease free survival and overall survival [Time Frame: 3 years]

incidence of treatment related toxicity and acute and chronic graft versus host disease [Time Frame: 100 days]

Secondary ID(s)

W-99-0234-FB

2001P002293

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen