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NCT00611351 · REGISTRY CONDITION SEARCH

Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating 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
2023-10-23

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with 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

Transplantation-related Mortality at 100 Days Post-transplantation

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outcome · POSTED

Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Event-free Survival

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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
Inclusion Criteria: * Pathologically confirmed diagnosis of 1 of the following: * Acute myeloid leukemia * Acute lymphocytic leukemia * Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis) * Multiple myeloma * Myelodysplastic syndromes * Malignant lymphoma * Myelofibrosis * Requirement for myeloablative conditioning regimen confirmed by attending physician * Available donor must meet the following criteria: * HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens * Matched at the A, B, and DRβ1 loci * Single HLA-A or HLA-B antigen mismatch allowed * Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors * Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed * Karnofsky performance status 70-100% * DLCO ≥ 50% predicted * LVEF ≥ 45% * Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min * Serum total bilirubin ≤ 2.0 mg/dL * Fertile patients must use effective contraception Exclusion Criteria: * No active uncontrolled infection * Not pregnant or nursing/negative pregnancy test * No HIV infection * No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy
healthy Volunteers
false
maximum Age
65 Years
minimum Age
19 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.
    intervention Names
    1. Biological: anti-thymocyte globulin
    2. Drug: busulfan
    3. Drug: cyclophosphamide
    4. Drug: mycophenolate mofetil
    5. Drug: tacrolimus
    6. Genetic: polymerase chain reaction
    7. Genetic: polymorphism analysis
    8. Other: flow cytometry
    9. Other: laboratory biomarker analysis
    10. Other: pharmacogenomic studies
    11. Other: pharmacological study
    12. Procedure: allogeneic bone marrow transplantation
    label
    Unrelated Donor Allogeneic
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    anti-thymocyte globulin
    other Names
    1. immunosuppressant
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    busulfan
    other Names
    1. Busulfex, Myleran
    type
    DRUG
  3. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    cyclophosphamide
    other Names
    1. cytophosphane
    type
    DRUG
  4. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    mycophenolate mofetil
    other Names
    1. CellCept
    type
    DRUG
  5. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    tacrolimus
    other Names
    1. Protopic, Envarsus XR, Astagraf XL
    type
    DRUG
  6. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    polymerase chain reaction
    type
    GENETIC
  7. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    polymorphism analysis
    type
    GENETIC
  8. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    flow cytometry
    type
    OTHER
  9. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    laboratory biomarker analysis
    type
    OTHER
  10. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    pharmacogenomic studies
    type
    OTHER
  11. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    pharmacological study
    type
    OTHER
  12. arm Group Labels
    1. Unrelated Donor Allogeneic
    name
    allogeneic bone marrow transplantation
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Transplantation-related Mortality at 100 Days Post-transplantation
    time Frame
    at the 100 days post-transplant
secondary Outcomes
  1. measure
    Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
    time Frame
    at day 100 post transplantation
  2. measure
    Overall Survival
    time Frame
    2 years post transplant
  3. measure
    Event-free Survival
    time Frame
    2 years post transplant
Full study description
brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.
detailed Description
OBJECTIVES: Primary * To determine the incidence of grade II-IV acute graft-versus-host disease in patients with hematologic cancer or other diseases treated with a myeloablative conditioning regimen comprising targeted (steady-state concentration of 800-1,000 ng/mL) busulfan, cyclophosphamide, and anti-thymocyte globulin followed by matched unrelated donor allogeneic hematopoietic stem cell transplantation. * To determine the day +100 transplantation-related mortality in these patients. Secondary * To determine the effect of cyclophosphamide pharmacokinetic parameters on day +100 transplantation-related mortality in these patients. * To determine the ability of low-dose anti-thymocyte globulin administered on day +5 to induce activation-induced cell death of activated donor lymphocytes. * To determine the incidence of chronic graft-versus-host disease in patients treated with this regimen. * To determine event-free and overall survival of patients treated with this regimen. * To evaluate pharmacogenomic associations between genetic polymorphisms in drug disposition enzymes with the pharmacokinetics of busulfan and cyclophosphamide. OUTLINE: * Myeloablative conditioning regimen: Patients receive busulfan IV over 2 hours on days -8 to -5; cyclophosphamide IV over 4 hours on days -3 to -2; and anti-thymocyte globulin IV over 6 hours on day -3 and then over 4 hours on days -2, -1, and 5. * Allogeneic hematopoietic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell infusion on day 0. * Graft-versus-host-disease prophylaxis: Patients receive tacrolimus IV continuously or orally on days 6 to150, followed by an even taper to day 180 in the absence of graft-versus-host-disease. Patients also receive mycophenolate mofetil IV or orally beginning on day 6 and continuing to day 28. Patients undergo blood collection periodically during study for pharmacokinetic, pharmacogenomic, and other translational studies. Genomic DNA extracted from blood samples is analyzed by polymerase chain reaction for genetic polymorphisms in cyclophosphamide/busulfan disposition enzymes. Activated donor lymphocytes are assessed using flow cytometry to measure activation-induced cell death, as reflected by apoptosis in activated T cells. Chimerism on or around day 100 is also assessed using fluorescence in situ hybridization analysis and DNA fingerprinting. After completion of study treatment, patients are followed periodically.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice