Clinical trial · Interventional
Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant
Rasburicase to Prevent Graft -Versus-Host Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| allopurinol | Drug | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporin-A | Drug | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| fludarabine | Drug | Fludarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rasburicase Group
- 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.
- interventionNames
- Drug: busulfan
- Drug: cyclophosphamide
- Drug: cyclosporin-A
- Drug: etoposide
- Drug: methotrexate
- Drug: rasburicase
- Drug: sirolimus
- Drug: tacrolimus
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: peripheral blood stem cell transplantation
- Radiation: total-body irradiation
- Drug: fludarabine
- type
- OTHER
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTYeh 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