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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: 8 August 2016
Main ID:  NCT00533923
Date of registration: 20/09/2007
Prospective Registration: No
Primary sponsor: Beth Israel Deaconess Medical Center
Public title: Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders
Scientific title: Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic Disorders
Date of first enrolment: December 2002
Target sample size: 25
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00533923
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
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:

- Age less than 65 years. There is no lower age limit. Patients 65 years and older will
be accrued on a case-by-case basis to this protocol, after discussion and approval by
the principal investigator. The acceptance to this protocol for such patients would
be based on the absence of coexisting medical problems, which would seriously
compromise the patient's ability to tolerate the known morbidity and risks of bone
marrow transplantation.

- Patients must have a 5/6 or 6/6 HLA matched, unrelated donor of bone marrow stem
cells.

- Each patient must be willing to participate as a research subject and must sign an
informed consent form after having been advised as to the nature and risk of the
study prior to entering the protocol. Parents or legal guardians of patients who are
minors will sign the informed consent form after being advised of the nature and
risks of the study. Attending physicians in the Bone Marrow Transplant Service will
enroll patients to this study and will obtain written consents.

Eligibility Criteria - Donor

- 5/6 or 6/6 HLA matched with the recipient as determined by molecular testing. Donors
will be identified through the National Marrow Donor Program for unrelated donors.

- Donor selection will be performed as outlined in the donor selection SOP's. In
patients who have more than one potential donor preference will be given to donors
who have no evidence of CMV exposure (if the recipient is CMV-), those who are
younger and those who are male. Selection of an unrelated donor from the NMDP
registry will proceed according to the donor selection SOP. Molecular testing of
HLA-A, B, and DR alleles will identify potential donors and the American Red Cross
HLA lab will confirm all typing. Donor selection will be coordinated with transplant
physician and the HLA laboratory director. Preference will be given to donors who are
6/6 molecular matches, those who are CMV- (if the recipient is CMV-), those who are
younger, and males.

Exclusion Criteria:

- Active CNS leukemia involvement.

- Female patients who are pregnant or breast feeding

- Karnofsky performance status < 70%, (appendix 1).

- Left ventricular ejection fraction of < 40%.

- Serum creatinine > 1.5 X normal

- Patients seropositive for HIV; HTLV -1, or with evidence of chronic active hepatitis
as demonstrated by detection of hepatitis surface antigen in the serum

- Patients with serologic evidence of hepatitis B or C exposure will undergo liver
biopsy to assess for presence of active hepatitis or fibrosis and quantification of
risk of proceeding with transplant

- Patients not providing informed consent.

- Patients with known hypersensitivity to E. Coli derived products.

- SGOT and SGPT > 2.5 x ULN, unless thought to be disease related

- Total bilirubin > 2.0 mg/dl, with direct bilirubin > 0.5 mg/dl



Age minimum: N/A
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
ALL
AML
Aplastic Anemia
CLL
Hodgkin's Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Myeloproliferative Disorder
Non-Hodgkin's Lymphoma
Intervention(s)
Drug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSF
Primary Outcome(s)
Primary objective of study is to determine the safety of non-myeloablative allogenic stem cell transplantation from matched unrelated donors in patients with hematologic malignancies with a focus on the incidence of treatment-related mortality. [Time Frame: Within 100 days of transplant]
Secondary Outcome(s)
Secondary clinical endpoints includes; incidence of graft failure or rejection; incidence and severity of acute and chronic GVHD; tumor response, and long-term overall and disease-free survival. [Time Frame: Within 100 days of transplant]
Secondary ID(s)
2002P000219
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bayer
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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