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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00636909
Other study ID # 2001P002293
Secondary ID W-99-0234-FB
Status Completed
Phase Phase 2
First received March 10, 2008
Last updated April 5, 2017
Start date July 1999

Study information

Verified date April 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group N/A to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide
preparative cytoreduction
fludarabine
preparative cytoreduction
cyclosporine
immunosuppressive therapy
methotrexate
immunosuppressive therapy
Biological:
G-CSF
foster engraftment

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Amgen

Outcome

Type Measure Description Time frame Safety issue
Primary durable engraftment 100 days
Primary hematopoeitic reconstitution 3 years
Primary evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells 3 years
Secondary disease free survival and overall survival 3 years
Secondary incidence of treatment related toxicity and acute and chronic graft versus host disease 100 days
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