Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies
Summary
This study will test the safety and effectiveness of adding bortezomib and vorinostat to other chemotherapy drugs commonly used to treat relapsed or refractory leukemia. Both drugs have been approved by the Food and Drug Administration (FDA) to treat other cancers in adults, but they have not yet been approved tor treatment younger patients with leukemia. PRIMARY OBJECTIVE * To estimate the overall response rate of patients with MLL rearranged (MLLr) hematologic malignancies receiving bortezomib and vorinostat in combination with a chemotherapy backbone. SECONDARY OBJECTIVES * Estimate event-free and overall-survival. * Describe toxicities experienced by participants during treatment. OTHER PRESPECIFIED OBJECTIVES * To identify all genomic lesions by comprehensive whole genome, exome and transcriptome sequencing on all patients. * To compare minimal residual disease (MRD) results by three modalities: flow cytometry, polymerase chain reaction (PCR) and deep sequencing.
Timeline
- Start
- 2015-04-14
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | Intravenous |
| Subject | Vorinostat | Small molecule | — | Oral |
| Background | Asparaginase Erwinia chrysanthemi | Protein / enzyme biologic | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Mitoxantrone | Small molecule | — | Intravenous |
| Background | Pegaspargase | Protein / enzyme biologic | — | Intravenous |