Clinical trial · Interventional
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation
- 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 low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| busulfan | Drug | Busulfan | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| Granulocyte colony-stimulating factor (G-CSF) | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| Phenytoin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
- description
- Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
- Drug: busulfan
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Drug: mycophenolate mofetil
- Procedure: peripheral blood stem cell transplantation
- Radiation: Total Body Irradiation (TBI)
- Drug: Granulocyte colony-stimulating factor (G-CSF)
- Drug: Phenytoin
- Drug: Methotrexate
Primary outcomes (2)
- measure
- Regimen-Related Toxicities
- timeFrame
- 5 years post-transplant
- description
- Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of a hematologic malignancy of 1 of the following high-risk types: * Acute lymphoblastic leukemia * Acute myeloid leukemia * Chronic myelogenous leukemia * Chronic lymphocytic leukemia * Myelodysplastic syndromes * Myeloproliferative disorder * Multiple myeloma * Plasma cell dyscrasias * Non-Hodgkin lymphoma * Hodgkin disease PATIENT CHARACTERISTICS: Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No liver failure * No cirrhosis with evidence of portal hypertension * No alcoholic hepatitis * No esophageal varices * No chronic hepatitis * No other liver disease Renal * Not specified Cardiovascular * Left Ventricular Ejection Fraction (LVEF) \> 35% * No symptomatic coronary artery disease or cardiac failure requiring therapy Pulmonary * Diffusing capacity of lung for carbon monoxide (DLCO) \> 30% * Total lung capacity \> 30% * Forced expiratory volume in 1 second (FEV\_1) \> 30% * No supplementary continuous oxygen Other * HIV negative * No active nonhematologic malignancy except localized skin cancer * No overt organ dysfunction PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (0)
Data not yet available