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NCT00134017 · REGISTRY CONDITION SEARCH

Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide 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
2018-08-31

RATIONALE: Giving chemotherapy before 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 cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for 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

Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)

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outcome · POSTED

Days to Engraftment

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outcome · POSTED

Chimerism

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outcome · POSTED

Non-relapse Mortality

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outcome · POSTED

Relapse

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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 myeloid leukemia (AML), meeting 1 of the following criteria: * AML beyond first complete remission (CR1) * Refractory AML * AML arising from myelodysplastic syndromes (MDS) * Secondary AML * MDS * Refractory anemia with excess blasts with \> 10% blasts in bone marrow * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * ALL in CR1 with 1 of the following high-risk features: * Philadelphia chromosome (Ph)-positive disease * Less than 1 year of age at diagnosis * Cytogenetic abnormalities involving chromosome 11q23 * ALL beyond CR1 * Refractory ALL * Chronic myeloid leukemia beyond first chronic phase * Chronic myelomonocytic leukemia * Chronic lymphocytic leukemia * Stage III-IV disease * Does not meet criteria for other bone marrow transplantation (BMT) studies * Myeloproliferative disorders * Ph-negative disease * Hodgkin's or non-Hodgkin's lymphoma * Chemotherapy-resistant disease * Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis * Multiple myeloma * Stage II or III disease * Very high-risk disease * Having an unrelated donor is considered a high-risk condition * Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center * Bone marrow donor available, meeting 1 of the following criteria: * Genotypically HLA-identical sibling * Phenotypically matched first-degree relative * Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1 PATIENT CHARACTERISTICS: Age * 6 months to 65 years Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent dexamethasone as an antiemetic during immunosuppression therapy Radiotherapy * Not specified Surgery * Not specified Other * No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)
healthy Volunteers
false
maximum Age
65 Years
minimum Age
6 Months
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis
    intervention Names
    1. Drug: Busulfan
    2. Drug: Cyclophosphamide
    label
    Bone marrow transplant
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Bone marrow transplant
    description
    Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m\^2 daily (for pediatric recipients)
    name
    Busulfan
    other Names
    1. Myleran
    2. Busulfex
    type
    DRUG
  2. arm Group Labels
    1. Bone marrow transplant
    description
    Days -3, -2, +3, +4: 50 mg/kg IV daily
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    2. CTX
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
142
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).
    measure
    Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
    time Frame
    Day 100
secondary Outcomes
  1. description
    Median number of days to neutrophil and platelet engraftment.
    measure
    Days to Engraftment
    time Frame
    Up to one year
  2. description
    Number of patients who achieved 100% donor chimerism.
    measure
    Chimerism
    time Frame
    Day 30, Day 60
  3. description
    Percentage of participants who died for BMT-related reasons.
    measure
    Non-relapse Mortality
    time Frame
    Day 100, 2 years
  4. description
    Percentage of participants who developed relapse or progressive disease.
    measure
    Relapse
    time Frame
    2 years
Full study description
brief Summary
RATIONALE: Giving chemotherapy before 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 cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
detailed Description
OBJECTIVES: Primary * Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil administered after myeloablative conditioning chemotherapy comprising busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation in patients with high-risk hematologic malignancies. * Determine the incidence and severity of acute graft-versus-host disease in patients treated with this regimen. * Determine other toxic effects of this regimen in these patients. Secondary * Determine immune reconstitution in patients treated with this regimen. * Determine disease control in patients treated with this regimen. OUTLINE: This is a pilot study. Patients are stratified according to age (≤ 19 years old vs \> 19 years old). * Myeloablative conditioning chemotherapy: Patients receive busulfan IV or orally 4 times daily on days -7 to -4 OR days -6 to -3 and cyclophosphamide IV over 1 hour once daily on days -3 to -1 OR days -2 and -1. * Allogeneic bone marrow transplantation: Patients undergo allogeneic bone marrow transplantation on day 0. * Immunosuppression therapy: Patients receive high-dose cyclophosphamide IV over 1 hour on days 3 and 4. After completion of study transplantation, patients are followed at 30 and 60 days, 6 months, 1 year, and then annually thereafter.
Source references
references
  1. citation
    Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2.
    pmid
    20124511
    type
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Source notices and limitations
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    Preserved source evidence · Not medical advice