Phase 1
Completed N=46
Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant
Source: ClinicalTrials.gov NCT00513474 ↗Enrolled (actual)
46
Serious AEs
45.2%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD) — 24; 57 percentage of participants — p=.036
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grades II to IV Acute Graft-Versus-Host Disease (aGVHD) |
24; 57 | .036 sig |
| SECONDARY Uric Acid Levels |
0.1; 4.157; 0.075; 3.419; 0.086; 2.967 | — |
| SECONDARY Number of Participant With Adverse Events (AE) |
21; 21 | — |
| SECONDARY Graft-versus-host and Host-versus-graft Immune Responses |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00513474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.