NCT03349281

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

A Phase I Trial of Pevonedistat in Combination With Induction Chemotherapy for Adolescent and Young Adults With Relapsed/Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Julio Barredo, MD · Academic / Other
• Sex: All
• Age: 16 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase I study of the addition of pevonedistat to induction chemotherapy for AYA patients (16-39 years of age) with relapsed/refractory ALL utilizing a traditional 3+3 design with dose expansion cohort of 6 patients. Starting dose level for pevonedistat is 15 mg/m2. If the number of dose-limiting toxicities (DLTs) is greater than 1 out of 3 patients in the starting dose level, next dose level is 10 mg/m2 (dose level -1). Chemotherapy will consist of pevonedistat in combination with a standard VXLD regimen. The duration of each cycle will be 29 days.

Conditions

• Refractory Acute Lymphoblastic Leukemia
• Relapsed Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Pevonedistat	Administered each cycle on days 1, 3 and 5.
DRUG	Vincristine	Administered each cycle on days 2, 9, 16 and 23.
DRUG	Dexamethasone	Taken orally each cycle on days 2 through 15.
DRUG	PEG-asparaginase	Administered via intramuscular injection (IM) each cycle on days 9 and 23.
DRUG	Doxorubicin	Administered via IV each cycle on day 2.
DRUG	Cytarabine	Administered to all subjects via IT injection on day 1; and on days 9, 16, and 23 to CNS positive subjects.
DRUG	Methotrexate	Administered via IT injection to CNS negative subjects on day 16; and to CNS positive subjects on days 9, 16 and 23.
DRUG	Hydrocortisone	Administered via IT injection to CNS positive subjects on days 9, 16, and 23.

Timeline

• Start date: 2019-03-25
• Primary completion: 2021-08-11
• Completion: 2022-10-12
• First posted: 2017-11-21
• Last updated: 2022-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study