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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Countries of recruitment
Contacts
Name:     David E Avigan, MD
Address: 
Telephone:
Email:
Affiliation:  Beth Israel Deaconess Medical Center
Name:     David F McDermott, MD
Address: 
Telephone:
Email:
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
ALL
AML
APLASTIC ANEMIA
CLL
CML Chronic Phase, Accelerated Phase, or Blast Crisis
MDS
MULTIPLE MYELOMA
MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)
RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
Intervention(s)
Biological: G-CSF
Drug: Cyclophosphamide
Drug: cyclosporine
Drug: fludarabine
Drug: methotrexate
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)
2001P002293
W-99-0234-FB
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Amgen
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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