Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil
Stopped early · Not applicable
Conditions studied: Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
In brief
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: To look at the ability of umbilical cord blood cells from one or two unrelated donors to serve as a source of stem cells for people needing a bone marrow transplant.
Key facts
- Study ID
- NCT00608517
- Run by
- Vanderbilt-Ingram Cancer Center
- People needed
- 6
- Starts
- 2005-09-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: any, up to 50. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Organ dysfunction as per standard guidelines. Unable to give informed consent (for adults only)
- Pregnant or lactating
- Sexually active individuals capable of becoming pregnant or causing a pregnancy who are unable or unwilling to use appropriate contraceptives.
- Active use of illicit drugs as evidenced by a positive toxicology screen for a substance not prescribed by a medical professional just prior to initiating the preparative regimen
- Actively smoking as evidenced by a positive nicotine screen just prior to initiating the preparative regimen
- HIV positive
- Patients with other unrelated malignancies will be excluded except:
- diagnosis of skin cancer (squamous cell or basal cell)
- diagnosis of cervical dysplasia (CIN I-III)
- any other malignancy which is currently in remission and was treated with curative intent more than 5 years preceding study entry
- In patients with secondary MDS or secondary acute leukemias-the previous non-hematopoietic neoplasm should be in remission but can be within 5 years of study entry
Where it is running
- Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center at Franklin — Nashville, Tennessee, United States
- Veterans Affairs Medical Center - Nashville — Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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