Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
NCT ID: NCT00045305
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2006-10-24
2014-09-30
Brief Summary
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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.
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Detailed Description
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* 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 extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a single-arm, two-stage, multicenter phase II study.
* Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously (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 would be accrued for this study within 2.1 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine
Immunosuppressant
Methotrexate
Antimetabolite
Photopheresis
Psoralens
Mycofenolate mofetil
an antibiotic with immunosuppressamt properties isolated from Penicillium spp
Pentostatin
Purine analogue
allogeneic bone marrow
Unmanipulated allogeneic bone marrow
peripheral blood stem cell
G-CSF mobilized peripheral blood stem cell
Total body irradiation
a total of 600 cGy given in 3 200 cGy fractionated doses
Interventions
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Cyclosporine
Immunosuppressant
Methotrexate
Antimetabolite
Photopheresis
Psoralens
Mycofenolate mofetil
an antibiotic with immunosuppressamt properties isolated from Penicillium spp
Pentostatin
Purine analogue
allogeneic bone marrow
Unmanipulated allogeneic bone marrow
peripheral blood stem cell
G-CSF mobilized peripheral blood stem cell
Total body irradiation
a total of 600 cGy given in 3 200 cGy fractionated doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts
* Chronic myelomonocytic leukemia
* International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
* Patients with an IPSS score less than 0.5 may be eligible provided they previously had a higher IPSS score and received chemotherapy at that time
* Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available
* No cord blood donors
* Related donors must be genotypically matched (HLA A, B and DR) at 5/6 or 6/6 loci and may be a sibling, parent, or child
* Unrelated donors must have high resolution typing done at A, B, C and DR, and must be matched at all or may have a single antigen or allele mismatch at no more than one of these loci
* Patients must have \< 20% blasts on bone marrow study within 1 month of study entry
* Age of 18 to 70 years
* Eastern Cooperative Oncology Group performance status 0-1
* Life expectancy at least 6 months
* At least 90 days since prior autologous bone marrow transplantation
* Serum erythropoietin level greater than 100 for patients who have not received a prior course of epoetin alfa
* No iron deficiency
* Iron deficiency anemia treated with iron replacement therapy allowed
* Bilirubin less than 2.0 mg/dL
* Alkaline phosphatase less than 2 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times ULN
* Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
* Left ventricular ejection fraction (LVEF) at least 45% by Multigated Acquisition scan (MUGA) or echocardiogram
* Carbon Monoxide Diffusing Capacity (DLCO) at least 50% of predicted (corrected for hemoglobin)
* Forced expiratory volume in 1 second (FEV\_1) at least 50% of predicted
* Recovered from prior chemotherapy
* Physically and psychologically capable of undergoing study regimen
* Able to receive 600 cGy of total body irradiation
* HIV negative
* Negative pregnancy test
Exclusion Criteria
* Having other medical condition that would reduce life expectancy
* Active ongoing infection
* Prior myeloablative or nonmyeloablative allogeneic transplantation for Myelodysplastic syndrome or acute myeloid leukemia
18 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Selina M. Luger, MD
Role: STUDY_CHAIR
Abramson Cancer Center at Penn Medicine
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Jewish Hospital Cancer Center
Cincinnati, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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E1902
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000256928
Identifier Type: -
Identifier Source: org_study_id
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