Phase 2
Completed N=147
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Source: ClinicalTrials.gov NCT00245037 ↗Enrolled (actual)
147
Serious AEs
40.1%
Results posted
Jul 2017
Primary outcomePrimary: Regimen-Related Toxicities — 21; 10; 8; 16 Toxicities
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regimen-Related Toxicities |
21; 10; 8; 16; 39; 30 | — |
| PRIMARY Non-relapse Mortality |
27; 33 | — |
| SECONDARY Overall Survival |
60; 48; 42; 29 | — |
| SECONDARY Progression-Free Survival |
48; 39; 35; 29 | — |
| SECONDARY Relapse Mortality |
13; 20 | — |
| SECONDARY Acute Graft-Versus-Host Disease (aGVHD) Outcome |
55; 60 | — |
| SECONDARY Chronic Graft-Versus-Host Disease (cGVHD) Outcome |
64.6; 66; 67.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00245037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.