Clinical trial · Interventional
Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases
A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy
- 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: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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 immunosuppressive therapy before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.
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 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Non-relapse mortality (NRM) at 200 days
Secondary outcomes (6)
- measure
- Overall survival
- measure
- Relapse rate
- measure
- Sinusoidal obstruction syndrome (SOS)
- measure
- Acute renal failure
- measure
- Respiratory failure
- measure
- Cause of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following: * Chronic myelogenous leukemia * Acute myeloid leukemia * Acute lymphocytic leukemia * Myelodysplastic syndromes * Lymphoma * Patients who have bulky tumor mass must not require additional involved-field irradiation * Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center * Must have an HLA-matched donor available * No donors who are mismatched for \> 1 HLA class I antigen or allele * Negative anti-donor lymphocytotoxic crossmatch PATIENT CHARACTERISTICS: * Life expectancy must not be severely limited by diseases other than malignancy * No moribund patients * Creatinine ≤ 1.2 mg/dL * Oxygen saturation on room air ≥ 93% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HIV positivity * No cirrhosis * No hepatic fibrosis with bridging * No fulminant hepatic failure * No acute liver injury * No persistent cholestasis * No infection requiring systemic antibiotic or antifungal therapy * No coronary artery disease * No congestive heart failure requiring therapy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior hematopoietic stem cell transplantation * No prior radiation therapy to the liver or adjacent organs * More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells * No concurrent enrollment in a phase I study
References
Publications (0)
Data not yet available