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NCT00513474 · REGISTRY CONDITION SEARCH

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

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

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2017-05-25

RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.

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 With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)

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outcome · POSTED

Uric Acid Levels

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outcome · POSTED

Number of Participant With Adverse Events (AE)

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outcome · POSTED

Graft-versus-host and Host-versus-graft Immune Responses

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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: * Patients with hematologic malignancies for whom conventional myeloablative allogeneic stem cell transplantation is deemed clinically appropriate and who are eligible for conventional myeloablative allogeneic stem cell transplantation on treatment plans/protocols, including any of the following: * Non-Hodgkin lymphoma or Hodgkin lymphoma (relapsed or refractory disease) * Chronic lymphocytic leukemia (received more than one previous treatment regimen) * Acute myelogenous or lymphoblastic leukemia (AML/ALL) (high-risk disease, in first complete remission \[CR1\] or subsequent remission, or primary refractory disease) * Chronic myelogenous leukemia in tyrosine-kinase resistant chronic phase, accelerated or blast phase, or primary refractory disease * Myelodysplastic syndromes in International Prognostic Scoring System (IPSS) high-intermediate or high-risk groups * Other hematologic disorders for which allogeneic stem cell transplantation is appropriate (e.g., myelofibrosis) * Patients who have relapsed after standard autologous and/or allogeneic bone marrow transplant are eligible * Must be receiving filgrastim (G-CSF)-mobilized related or unrelated donor allogeneic peripheral blood stem cells * Patients receiving hematopoietic stem cells of any other sources such as a marrow graft or umbilical cord blood will not be eligible for this study * Donor must be HLA-genotypically or phenotypically 6 of 6 antigen matched (at the A, B, DR loci) related or unrelated PATIENT CHARACTERISTICS: Inclusion criteria: * Patients with a "currently active" second malignancy other than non-melanoma skin cancers can only be registered if survival from the second malignancy is expected to be more than 1 year * Ejection fraction ≥ 45% by either radioisotope Multiple Gated Acquisition Scan (MUGA) scan or Echocardiogram (ECHO) * Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ≥ 50% of predicted with no symptomatic pulmonary disease * Mini Mental Status Exam Score ≥ 20 * Patients must have an expected life expectancy of at least 3 months * Patients with symptomatic visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled * Patients with a fungal infection must have had treatment for at least one month and must have proof of regression of the infection prior to enrollment * Patients may be on antibiotics at the time of transplant Exclusion criteria: * Human Immunodeficiency Virus (HIV) infection * Uncontrolled diabetes mellitus * Active congestive heart failure from any cause * Previous history of congestive heart failure allowed * Active angina pectoris * Oxygen-dependent obstructive pulmonary disease * Failure to demonstrate adequate compliance with medical therapy and follow-up * Known history of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency or history of hemolysis indicative of G6PD deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclophosphamide
    3. Drug: cyclosporin-A
    4. Drug: etoposide
    5. Drug: methotrexate
    6. Drug: rasburicase
    7. Drug: sirolimus
    8. Drug: tacrolimus
    9. Procedure: allogeneic hematopoietic stem cell transplantation
    10. Procedure: peripheral blood stem cell transplantation
    11. Radiation: total-body irradiation
    12. Drug: fludarabine
    label
    Rasburicase Group
    type
    EXPERIMENTAL
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    intervention Names
    1. Drug: busulfan
    2. Drug: cyclophosphamide
    3. Drug: cyclosporin-A
    4. Drug: etoposide
    5. Drug: methotrexate
    6. Drug: sirolimus
    7. Drug: tacrolimus
    8. Procedure: allogeneic hematopoietic stem cell transplantation
    9. Procedure: peripheral blood stem cell transplantation
    10. Radiation: total-body irradiation
    11. Drug: fludarabine
    12. Drug: allopurinol
    label
    Control Group
    type
    OTHER
interventions
  1. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Busulfan 3.2 mg/kg/day from day -7 to day -4 as standard of care for myeloablative (bone marrow depletion) conditioning at the investigator's discretion
    name
    busulfan
    type
    DRUG
  2. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion
    name
    cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion
    name
    cyclosporin-A
    type
    DRUG
  4. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Etoposide as standard of care for myeloablative conditioning at the investigator's discretion
    name
    etoposide
    type
    DRUG
  5. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion
    name
    methotrexate
    type
    DRUG
  6. arm Group Labels
    1. Rasburicase Group
    description
    Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days
    name
    rasburicase
    type
    DRUG
  7. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion
    name
    sirolimus
    type
    DRUG
  8. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion
    name
    tacrolimus
    type
    DRUG
  9. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    name
    allogeneic hematopoietic stem cell transplantation
    type
    PROCEDURE
  10. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    name
    peripheral blood stem cell transplantation
    type
    PROCEDURE
  11. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion
    name
    total-body irradiation
    type
    RADIATION
  12. arm Group Labels
    1. Control Group
    2. Rasburicase Group
    description
    Fludarabine 40 mg/m\^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion
    name
    fludarabine
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
46
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    aGVHD severity was determined using International Bone Marrow Transplant Registry (IBMTR) scale stage and grade of the skin, liver and gut. Stage 1: Skin=maculopapular rash \<25% of body surface; Liver=Bilirubin 2-3 mg/dL and Gut=500-999 mL diarrhea/day or peristent nausea with histologic evidence of GvHD. Stage 2: Skin=maculopapular rash 25-50% of body surface; Liver=Bilirubin 3.1-6 mg/dL and Gut=1000-1499 mL diarrhea/day. Stage 3: Skin=maculopapular rash \>50% of body surface; Liver=Bilirubin 6.1-15 mg/dL and Gut=≥1500 mL diarrhea/day. Stage 4: Skin=generalized erythroderma with bulla formation; Liver=Bilirubin \>15 mg/dL and Gut=severe abdominal pain. Grade 1: Stage 1-2 rash; no liver or gut involvement. Grade II: Stage 3 rash, or stage 1 liver involvement, or stage 1 gut involvement. Grade III: None to stage 3 skin rash with stage 2-3 liver, or stage 2-4 gut involvement. Grade IV: Stage 4 skin rash, or stage 4 liver involvement.
    measure
    Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD)
    time Frame
    Up to 71 months
secondary Outcomes
  1. description
    Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.
    measure
    Uric Acid Levels
    time Frame
    Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6
  2. description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
    measure
    Number of Participant With Adverse Events (AE)
    time Frame
    Up to 71 months
  3. description
    Laboratory tests such as limited dilution assay (LDA) were to be performed to assess graft-versus-host and host-versus-graft immune responses.
    measure
    Graft-versus-host and Host-versus-graft Immune Responses
    time Frame
    Days -2, 0, and Days 14, 21 and 35 days post-transplant
Full study description
brief Summary
RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.
detailed Description
OBJECTIVES: Primary * To evaluate the incidence and severity of acute graft-vs-host disease (GVHD) in rasburicase-treated patients who will undergo myeloablative human leukocyte antigen (HLA)-matched related or unrelated donor allogeneic peripheral blood hematopoietic stem cell transplantation (SCT) for hematologic malignancies and compare these outcomes with those of historical controls. Secondary * To evaluate the efficacy (in terms of reduction of uric acid levels) and safety of rasburicase in patients undergoing myeloablative allogeneic SCT. * To evaluate the graft-versus-host and host-versus-graft immune responses in rasburicase-treated patients. OUTLINE: This is a multicenter study. Patients receive a conventional myeloablative conditioning regimen consisting of high doses of cyclophosphamide, busulfan, and etoposide, with or without total-body irradiation. Depending on the preparative regimen selected, the conditioning of recipients will take a total of 6 to 7 days. On day 0, patients will receive filgrastim (G-CSF)-mobilized HLA-matched, related, or unrelated donor allogeneic peripheral blood stem cells (unmanipulated). Patients will receive standard graft-vs-host disease prophylaxis consisting of cyclosporine or tacrolimus and methotrexate or sirolimus. Patients will receive rasburicase IV over 30 minutes, beginning on the first day of conditioning therapy, for 5 consecutive days. If after 5 days of rasburicase the patient's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total. Blood is obtained on day 0 and then at 14, 28, and 42 days post-transplant for immunologic studies, including quantitative analysis to follow the recovery of T cells, B cells, natural killer cells, dendritic cells (DC), and monocytes using flow cytometry (FCM); phenotypic analysis of T cells, DC and monocytes by FCM; lymphocyte activation analysis: CD3, CD4, CD8, CD25 2. CD3, CD8, CD71, CD69; DC analysis: CD45, CD14, DR, CD86, CD80 2. CD45, CD14, CD40, CD11c; and in vitro functional studies such as mixed lymphocyte reaction (MLR) and cell-mediated lysis (CML) to assess for the graft-versus-host and host-versus-graft responses. Peripheral blood is collected for chimerism studies on days 28 and 100 post-transplant. After completion of study treatment, patients are followed periodically.
Source references
references
  1. citation
    Yeh AC, Brunner AM, Spitzer TR, Chen YB, Coughlin E, McAfee S, Ballen K, Attar E, Caron M, Preffer FI, Yeap BY, Dey BR. Phase I study of urate oxidase in the reduction of acute graft-versus-host disease after myeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 May;20(5):730-4. doi: 10.1016/j.bbmt.2014.02.003. Epub 2014 Feb 12.
    pmid
    24530972
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice