Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies
Stopped early · Phase 2/Phase 3
Conditions studied: Multiple Myeloma, CLL / SLL, Non Hodgkin's Lymphoma, Waldenstroms, Mantle Cell Lymphoma
In brief
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 treatment related mortality.
Key facts
- Study ID
- NCT00714259
- Run by
- University of Alabama at Birmingham
- People needed
- 5
- Starts
- 2008-07-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2017-07-24
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Alabama in Birmingham BMT/CT Program Outpatient Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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