Clinical trial · Interventional
Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation 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: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
Conditions
Conditions (4)
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/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of hematological malignancy, including any of the following:
* Chronic myeloid leukemia
* Acute myeloid leukemia
* Acute lymphocytic leukemia
* Myelodysplastic syndromes
* Lymphoma
* Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation
* No bulky tumor mass requiring additional involved field radiotherapy
* No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide
* Undergoing conditioning for transplantation at the University of Washington Medical Center
* Availability of 1 of the following types of allogeneic donors:
* HLA-identical family members
* Unrelated donors
* Allele match (match grade 1)
* One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2)
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* Not specified
Life expectancy
* Not severely limited by diseases other than malignancy
* Not moribund
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 1.2 mg/dL
* No cirrhosis
* No hepatic fibrosis with bridging
Renal
* Creatinine no greater than 1.2 mg/dL
Cardiovascular
* No coronary artery disease
* No congestive heart failure requiring therapy
Pulmonary
* Oxygen saturation at least 93% (on room air)
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No concurrent infection requiring systemic antibiotic or antifungal therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior hematopoietic stem cell transplantation
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy to the liver or adjacent organs
Surgery
* Not specified
Other
* No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®)
* No other concurrent phase I study enrollmentReferences
Publications (0)
Data not yet available