Phase 2
Completed N=210
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
Source: ClinicalTrials.gov NCT00134004 ↗Enrolled (actual)
210
Serious AEs
9.5%
Results posted
Aug 2015
Primary outcomePrimary: Transplant-related Mortality — 18 percentage of participants
Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transplant-related Mortality |
18 | — |
| PRIMARY Relapse Rate |
55 | — |
| PRIMARY Progression-free Survival |
34 | — |
| SECONDARY Graft Failure Rate |
13 | — |
| SECONDARY Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation |
9.5 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute leukemia
- In second or subsequent complete remission (CR), as defined by absence of abnormal blast population by flow cytometry
- In first CR with any of the following poor-risk cytogenetic features:
- Alteration of chromosome 5 or 7
- Multiple abnormalities
- Philadelphia chromosome positive
- Chronic phase chronic myelogenous leukemia (CML)
- In first chronic phase and refractory to interferon alfa or imatinib mesylate
- In second or subsequent chronic phase
- Chronic lymphocytic leukemia, meeting 1 of the following criteria:
- Received prior chemotherapy with a nucleoside analog and had remission lasting 2.0 mg/dL (unless documented Gilbert's disease)
- Creatinine > 2.0 mg/dL
- Non-Hodgkin's lymphoma (NHL)
- Low-grade NHL allowed provided patient had a remission duration of 30,000/mm^3
- Polycythemia vera or essential thrombocythemia in "spent" phase, with a history of 2 of the following:
- Marrow fibrosis
- Splenomegaly
- Cytopenia (i.e., absolute neutrophil count < 1,500/mm^3, platelet count < 100,000/mm^3, hemoglobin < 10 g/dL)
- Polycythemia vera or essential thrombocythemia with transformation to myelodysplastic syndromes or acute myeloid leukemia (requires treatment to achieve < 20% blasts in marrow)
- No smoldering myeloma
- Patients with acute myeloid leukemia or myelodysplastic syndromes must have had comprehensive cytogenetic evaluation of bone marrow specimen during active disease
- Ineligible for or refused bone marrow transplantation from an HLA-matched sibling or unrelated donor
- Ineligible for or refused autologous SCT
- Must have an HLA mismatched (i.e., 3/6, 4/6, or 5/6) related (first-degree relative)* donor available
- Donor ≥ 18 years of age NOTE: *Patients with an inherited recombinant HLA haplotype may receive marrow from the parent in whose gamete the recombination occurred
NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 6 months to 74 years
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- See Disease Characteristics
- Bilirubin < 3.1 mg/dL
Renal
- See Disease Characteristics
Cardiovascular
- See Disease Characteristics
- LVEF ≥ 35%
Pulmonary
- See Disease Characteristics
- FEV\_1 or FVC ≥ 40% of predicted in patients without prior thoracic or mantle radiotherapy (60% of predicted in patients with prior thoracic or mantle radiotherapy)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- Geographically accessible
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior transfusions from donor
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Data sourced from ClinicalTrials.gov (NCT00134004). 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.