drugset
drugset / Trial / NCT03349281

Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

NCT03349281 ↗

Phase 1 Completed 6 enrolled University of Miami Takeda · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The investigators postulate that Pevonedistat will be effective in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) when combined with a standard backbone ALL chemotherapy regimen.

Timeline

Start
2019-03-25
Primary completion
2021-08-11
Completion
2022-10-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pevonedistat Small molecule 10 mg/m2 Intravenous
Subject Pevonedistat Small molecule 15 mg/m2 Intravenous
Subject Pevonedistat Small molecule 20 mg/m2 Intravenous
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 70 mg Intrathecal
Background Dexamethasone Small molecule 10 mg/m2 Oral
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Hydrocortisone Other / unclassified 15 mg Intrathecal
Background Methotrexate Small molecule 15 mg Intrathecal
Background Pegaspargase Protein / enzyme biologic 2000 unknown Intramuscular
Background Vincristine Small molecule 1.5 mg/m2 Intravenous

Indications

acute lymphoblastic leukemia