Status:
TERMINATED
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Multiple Myeloma
CLL / SLL
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
PHASE3
Brief Summary
A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high...
Detailed Description
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 myelo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00714259
Start Date
July 1 2008
End Date
February 1 2013
Last Update
July 24 2017
Active Locations (1)
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1
University of Alabama in Birmingham BMT/CT Program Outpatient Clinic
Birmingham, Alabama, United States, 35249-6979