NCT05016947

Venetoclax Plus Inotuzumab for B-ALL

A Phase 1 Study of Venetoclax in Combination With Inotuzumab Ozogamicin for B-cell Acute Lymphoblastic Leukemia (B-ALL)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating the safety and efficacy of administering venetoclax and inotuzumab ozogamicin in combination in patients with acute lymphoblastic leukemia (ALL) The names of the study drugs involved in this study are: * Venetoclax * Inotuzumab ozogamicin * Dexamethasone

Detailed description

This is a phase I study of venetoclax in combination with inotuzumab ozogamicin for the treatment of CD22-positive (CD22+) B-cell acute lymphoblastic leukemia (B-ALL) and lymphoma (B-LBL), hereafter referred to as "ALL," in patients with disease relapsed from or refractory (R/R) to prior intensive chemotherapy. The U.S. Food and Drug Administration (FDA) has not approved venetoclax for ALL but it has been approved for other uses. Venetoclax is an oral (pill) chemotherapy that works by blocking the action of certain proteins in cancer cells that help those cells survive. The U.S. Food and Drug Administration (FDA) has approved inotuzumab ozogamicin as a treatment option for ALL but not in combination with other drugs. Inotuzumab ozogamicin is an antibody-drug conjugate. An antibody-drug conjugate is a medication where a cancer drug (chemotherapy) is attached to an antibody, an immune system protein, that targets a specific protein on the cancer cell. Inotuzumab ozogamicin is combination of an antibody that targets the CD22 protein on ALL cells and calicheamicin, a chemotherapy compound that kills cancer cells. Once the antibody portion of inotuzumab ozogamicin binds to CD22 protein on cancer cells, the calicheamicin is released into the cell, where it damages the cancer cell's DNA and causes its death. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for approximately 6-9 months depending on their response to the study treatment and followed for two years after completion of study. It is expected that 20 to 32 people will take part in this research study. Abbvie is supporting this research study by providing the study drug venetoclax and funding research tests and procedures.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• B-Cell Lymphoma
• ALL

Interventions

Type	Name	Description
DRUG	Venetoclax	Tablet, taken by mouth
DRUG	Dexamethasone	Taken orally
DRUG	Inotuzumab Ozogamicin	Intravenous infusion

Timeline

• Start date: 2021-09-24
• Primary completion: 2023-07-10
• Completion: 2026-12-23
• First posted: 2021-08-23
• Last updated: 2026-01-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study