Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplantation
18 Years
N/A
Both
Hodgkin's Disease, Non Hodgkin's Lymphoma, Myeloma, Leukemia, Myelodysplasia
Trial Information
Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplantation
The central hypothesis of this study is that use of a less toxic chemotherapy preparative
regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell
depletion with alemtuzumab for patients with high risk hematologic malignancies will allow
effective control of disease and improved disease free and overall survival compared with
historical expectations. Specifically, the objectives are to estimate toxicity, disease
free, progression free, event free and overall survival rates in patients treated with an
alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic
hematopoietic transplantation; evaluate immune recovery following this reduced intensity
allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted
dosing. The study population is HIV negative, adult patients who are not pregnant but have
confirmed diagnosis of disease; must have CALGB PS 0, 1, or 2; must have a 3-6/6 HLA-matched
related donor or 8/8 (A, B, C, DRB1, DQ are the primary determinants) or better HLA-matched
unrelated donor who is evaluated and deemed able to provide PBPCs and/or marrow by the
transplant team. The target population of patients is those with a high chance of
progressive lymphoid or myelomatous diseases, progressive myeloid diseases, marrow failure
syndromes or myeloproliferative disorders.
Inclusion Criteria:
- Patients must have their diagnosis confirmed at the transplant center.
- Performance status must be CALGB PS 0, 1, or 2.
- Patients must have a 3-6/6 HLA-matched related donor or 8/8 or better allele level
match MUD matched unrelated donor (at A,B, C, DRB1, DQ).
- HIV negative.
- Women of child bearing potential must have a negative pregnancy serum beta-HCG test
within 1 week of starting therapy.
- Patients > or equal to 18 years of age are eligible.
- Patients must have a MUGA and/or ECHO or cardiac MR and PFTs with DLCO performed
before transplant.
- Specific patient populations:
- Group A) Patients with a high chance of progressive lymphoid or myelomatous
diseases.
- Group B) Patients with a high chance of progressive myeloid diseases, marrow
failure syndromes or myeloproliferative disorders
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with other major medical or psychiatric illnesses which the treating
physician feels could seriously compromise tolerance to this protocol.
- Patients with uncontrolled, progressive infections.
- Patients who are good candidates for long term disease control with standard
chemotherapy or radiation or high dose therapy and autologous support.
- Patients with active CNS disease.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Estimate toxicity, disease free, progression free and overall survival rates in patients treated with an alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation
Outcome Time Frame:
36 months
Safety Issue:
Yes
Principal Investigator
David Rizzieri, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University Health System
Authority:
United States: Institutional Review Board
Study ID:
Pro00003567
NCT ID:
NCT00597714
Start Date:
February 2008
Completion Date:
January 2017
Related Keywords:
- Hodgkin's Disease
- Non Hodgkin's Lymphoma
- Myeloma
- Leukemia
- Myelodysplasia
- Stem Cell Transplantation, Non-myeloablative
- Hodgkin Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Duke University Health System | Durham, North Carolina 27705 |
