Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
Drug: mycophenolate mofetil
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes|
- Complete response rate at day 100 after transplant [ Designated as safety issue: No ]
- Disease-free survival (DFS) 1-2 years after completion of study treatment [ Designated as safety issue: No ]
- Overall survival (OS) 1-2 years after completion of study treatment [ Designated as safety issue: No ]
- Engraftment of donor cells at days 30 and 100 [ Designated as safety issue: No ]
- Toxicity or acute graft-versus-host disease at days 1-100 [ Designated as safety issue: Yes ]
- Chronic graft-versus-host disease at 6 months, and then 1 and 2 years [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
- Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation, including photopheresis, total body irradiation, and pentostatin.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the engraftment rate of donor cells in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin IV continuously on days -5 and -4. Total body irradiation is administered on days -3 and -2 for a total of 3 doses.
- Transplantation: Allogeneic bone marrow or peripheral blood stem cells are infused on day 0.
- Acute graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours. Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD. Once cyclosporine dose is significantly decreased, oral mycophenolate mofetil (MMF) is then administered twice a day. MMF dose is then tapered for 12 months in the absence of GVHD. Patients also receive methotrexate IV on days 1 and 3.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 2.1 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045305
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Massachusetts|
|Tufts-NEMC Cancer Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Jewish Hospital Cancer Center|
|Cincinnati, Ohio, United States, 45236|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Selina M. Luger, MD||Abramson Cancer Center of the University of Pennsylvania|