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NCT00534430 · REGISTRY CONDITION SEARCH

Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced 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
2026-06-03

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

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

Overall Survival at 5 Years Post-Transplant.

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outcome · POSTED

Disease-free Survival at Five Years Post-transplant

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outcome · POSTED

Overall Survival Comparing Diagnosis Groups

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outcome · POSTED

Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared.

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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: * Acute myeloid leukemia (AML) * Failed remission induction therapy or in relapse beyond second remission * In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7, -5, complex abnormalities \[i.e., \> 3 abnormalities, 6;9 translocation and 3q abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q, 20q, 21q, 17q, t(9;21)\]) * Acute lymphoblastic leukemia (ALL) * Failed remission induction therapy or in relapse beyond second remission * Blastic phase chronic myelogenous leukemia * Refractory anemia with excess blasts * Refractory anemia with excess blasts in transformation * HLA -A, -B, -C, -DR identical sibling donor match available * No relapse after prior bone marrow transplantation PATIENT CHARACTERISTICS: * Cardiac ejection fraction ≥ 50% * Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance \> 80 mL/min * Bilirubin ≤ 1.5 times ULN * AST and ALT \< 5 times ULN * FEV\_1 ≥ 50% of predicted normal * DLCO ≥ 50% of predicted normal * No psychological or medical condition that would preclude allogeneic transplantation (in the opinion of the treating physician) * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 28 days since prior induction or reinduction therapy * Prior etoposide and busulfan allowed * No prior radiation therapy that would exclude total-body irradiation
healthy Volunteers
false
maximum Age
50 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclosporine
    3. Drug: etoposide
    4. Drug: mycophenolate mofetil
    5. Procedure: allogeneic bone marrow transplantation
    6. Procedure: allogeneic hematopoietic stem cell transplantation
    7. Procedure: peripheral blood stem cell transplantation
    8. Radiation: total-body irradiation
    label
    Busulfan, FTBI and VP16
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    busulfan
    type
    DRUG
  2. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    cyclosporine
    type
    DRUG
  3. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    etoposide
    type
    DRUG
  4. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    mycophenolate mofetil
    type
    DRUG
  5. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    allogeneic bone marrow transplantation
    type
    PROCEDURE
  6. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  7. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
  8. arm Group Labels
    1. Busulfan, FTBI and VP16
    name
    total-body irradiation
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
30
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
    measure
    Overall Survival at 5 Years Post-Transplant.
    time Frame
    Date of Transplant to Five Years post-Transplant
  2. description
    Kaplan-Meier estimate of an event of relapse or death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
    measure
    Disease-free Survival at Five Years Post-transplant
    time Frame
    Date of transplant to five years post-transplant
  3. description
    Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
    measure
    Overall Survival Comparing Diagnosis Groups
    time Frame
    Date of Transplant to Five Years post-Transplant
  4. description
    Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%.
    measure
    Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared.
    time Frame
    Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant.
Full study description
brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.
detailed Description
OBJECTIVES: * To determine the efficacy of a preparative regimen comprising dose targeted busulfan, etoposide, and fractionated total-body irradiation followed by allogeneic hematopoietic stem cell or bone marrow transplantation in patients with advanced hematologic malignancies. * To determine the efficacy of this regimen in patients with acute myeloid leukemia in first remission with unfavorable cytogenetics. * To evaluate the early and late toxicities of this regimen. OUTLINE: * Preparative chemotherapy regimen: Patients receive busulfan IV over 2 hours once every 6 hours on days -14 to -8 for a total of 16 doses and etoposide IV on day -3.\* NOTE: \*Patients also receive oral or IV dilantin 1-3 times daily on days -18 to -5 for prophylaxis of grand mal seizures. * Fractionated total-body irradiation (FTBI): Patients undergo FTBI on days -7 to -4 for a total of 10 fractions. * Allogeneic transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 50 followed by a taper to day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil orally or IV over 2 hours twice daily on days 0-27, followed by a taper until day 56. After completion of study treatment, patients are followed annually for 2 years.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice