UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
19 Years
70 Years
Both
Multiple Myeloma, CLL / SLL, Non Hodgkin's Lymphoma, Waldenstroms, Mantle Cell Lymphoma
Trial Information
UAB 0775 Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation Protocol From HLA Matched Related Donors for The Treatment of Patients With Low Grade B Cell Malignancies
Non myeloablative transplant aims to achieve the immunological advantage of graft versus
tumor effect as conventional myeloablative therapy without causing high treatment related
toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to
achieve longer disease free and over all survival in patients with low grade B-cell
malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative
HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma
and other malignant B-cell malignancies if the transplant is performed for low grade, low
volume disease.
Inclusion Criteria:
- Stage II or III non-progressive disease Multiple Myeloma.
- CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or
complete response with non-progressive disease.
- ≤ 70 years old.
- Eligible and willing HLA matched related donor.
- Bilirubin <2xULN.
- ALT and AST <3xULN.
- LVEF > 40%.
- Creatinine Clearance >40mL/min.
- Pulmonary function DLCO corrected to ≥ 70%.
- Minimum performance score of 70%.
- Platelet count >130 x103 micro L.
- LDH ≤1.5xULN.
- No proceeding co-morbid condition that significantly increases the risk of severe
regimen related toxicity.
- No uncontrolled infections.
Exclusion Criteria:
- Age >70 years old.
- Performance status <70%.
- Uncontrolled infections or is HIV positive
- Prior malignancies that are felt to have a <80% probability of being cured.
- Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12
months following transplant.
- Prior Allograft
- History of rapidly growing disease at diagnosis or at any progression or have MDS.
- No eligible and willing HLA matched donor.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progressive Free Survival Post Transplant
Outcome Time Frame:
100, 180, 365 days post transplant; then yearly until 3 years post transplant
Safety Issue:
No
Principal Investigator
William P. Vaughan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama in Birmingham
Authority:
United States: Institutional Review Board
Study ID:
F080429003
NCT ID:
NCT00714259
Start Date:
July 2008
Completion Date:
February 2013
Related Keywords:
- Multiple Myeloma
- CLL / SLL
- Non Hodgkin's Lymphoma
- Waldenstroms
- Mantle Cell Lymphoma
- Low Grade B Cell Malignancies
- nonmyeloablative transplant
- allogeneic
- Neoplasms
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| University of Alabama in Birmingham BMT/CT Program Outpatient Clinic | Birmingham, Alabama 35249-6979 |
