NCT00134004 · REGISTRY CONDITION SEARCH

Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2015-10-06

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Transplant-related Mortality

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outcome · POSTED

Relapse Rate

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Graft Failure Rate

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outcome · POSTED

Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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 \< 6 months * Received 1 prior therapy and has any of the following high-risk features: * Cytogenetic abnormalities of 17p, 11q * Mutations of the Zap70 gene * Somatically unmutated immunoglobulin heavy chain variable region genes * Hodgkin's lymphoma * Ineligible for autologous stem cell transplantation (SCT) due to any of the following exclusion factors: * LVEF \< 45% * FEV\_1 or FVC \< 50% of predicted (75% of predicted in patients with prior thoracic or mantle radiotherapy) * Total bilirubin \> 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 \< 1 year after administration of any established, multi-agent chemotherapy regimen (e.g., CVP, CHOP, or rituximab in combination with CHOP) * Intermediate- or high-grade NHL allowed provided patient is ineligible for autologous SCT according to the criteria listed above * Multiple myeloma * Myelodysplastic syndromes * Paroxysmal nocturnal hemoglobinuria * Chronic myeloproliferative disorders other than CML, including any of the following: * Chronic myelomonocytic leukemia * Agnogenic myeloid metaplasia (or myeloid metaplasia with myelofibrosis), with hemoglobin \< 10 g/dL OR WBC \< 4,000/mm\^3 or \> 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
healthy Volunteers: false
maximum Age: 74 Years
minimum Age: 6 Months
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
intervention Names
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
label
Mini-haplo Transplant
type
EXPERIMENTAL

interventions

arm Group Labels
Mini-haplo Transplant
name
cyclophosphamide
type
DRUG
arm Group Labels
Mini-haplo Transplant
name
fludarabine phosphate
type
DRUG
arm Group Labels
Mini-haplo Transplant
name
mycophenolate mofetil
type
DRUG
arm Group Labels
Mini-haplo Transplant
name
tacrolimus
type
DRUG
arm Group Labels
Mini-haplo Transplant
name
allogeneic bone marrow transplantation
type
PROCEDURE
arm Group Labels
Mini-haplo Transplant
name
radiation therapy
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 210
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Percentage of participants who die for any reason other than recurrence of disease.
measure
Transplant-related Mortality
time Frame
Cumulative incidence for the entire study, up to 11 years
description
Percentage of participants who experience disease relapse.
measure
Relapse Rate
time Frame
Cumulative incidence for the entire study, up to 11 years
description
Percentage of participants who do not experience disease relapse, disease progression, or death.
measure
Progression-free Survival
time Frame
2 years

secondary Outcomes

description
Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as \<5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure.
measure
Graft Failure Rate
time Frame
Cumulative incidence for the entire study, up to 11 years
description
Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables.
measure
Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation
time Frame
1 year

Full study description

brief 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.
detailed Description: OBJECTIVES: * Determine transplant-related mortality, risk of relapse, and progression-free survival of patients with standard- or high-risk hematologic malignancies undergoing nonmyeloablative conditioning comprising fludarabine, cyclophosphamide, and total-body irradiation followed by HLA-haploidentical allogeneic bone marrow transplantation. * Determine donor hematopoietic chimerism in patients' peripheral blood at 30, 60, and 180 days after transplantation. * Determine hematologic and nonhematologic toxic effects of this regimen in these patients. * Determine, when feasible, surface expression of HLA molecules and death receptors, sensitivity to cytotoxic lymphocytes, and expression of anti-apoptotic genes (e.g., Bcl-2, Bcl-xL, X-IAP, and c-FLIP) in cancer cells from patients who relapse after treatment with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to risk of relapse (standard \[defined as ≤ 30% risk\] vs high \[defined as ≥ 70% risk\]). * Nonmyeloablative conditioning regimen: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5. Patients undergo total body irradiation on day -1. * Allogeneic bone marrow transplantation: Patients undergo donor bone marrow infusion on day 0. * Post-transplantation therapy: Patients receive cyclophosphamide IV over 1-2 hours on days 3 and 4. * Graft-vs-host disease prophylaxis: Beginning on day 5, patients receive oral mycophenolate mofetil 3 times daily until day 35 and tacrolimus IV (then changing to orally) twice daily until day 180. Treatment continues in the absence of disease progression. After completion of study transplantation, patients are followed on days 30, 60, 100, and 180; at 1 year; and then annually for 4 additional years. PROJECTED ACCRUAL: A total of 75-100 patients will be accrued for this study within 3-4 years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice