Clinical trial · Interventional
Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow | Procedure | — | UNRESOLVED |
| Cyclosporine | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Mycofenolate mofetil | Drug | — | UNRESOLVED |
| Pentostatin | Drug | Pentostatin | ALIAS |
| peripheral blood stem cell | Procedure | — | UNRESOLVED |
| Photopheresis | Drug | — | UNRESOLVED |
| Total body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: Cyclosporine
- Drug: Methotrexate
- Drug: Photopheresis
- Drug: Mycofenolate mofetil
- Drug: Pentostatin
- Procedure: allogeneic bone marrow
- Procedure: peripheral blood stem cell
- Radiation: Total body irradiation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * One of the following cytologically proven myelodysplastic syndromes * 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: * Pregnant or nursing * 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
References
Publications (0)
Data not yet available