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Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

NCT05065866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-04

No results posted yet for this study

Summary

The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with duvelisib.

Conditions

Interventions

DRUG

BMS-986345

Patients will be treated at the following dose levels: Duvelisib BMS-986345 Dose Level 15 mg twice daily 100mg daily -1 25 mg twice daily 100mg daily 1 50 mg twice daily 100mg daily 2 75 mg twice daily 100mg daily 3 75 mg twice daily 200mg daily 4 75 mg twice daily 300mg daily 5 After the first two cycles of treatment, the dose of Duvelisib will be dropped to 25 mg twice daily irrespective of the starting dose level unless the patient is at dose level -1 then they will stay on that dose level after the initial 2 cycles

DRUG

Duvelisib

Patients will be treated at the following dose levels: Duvelisib BMS-986345 Dose Level 15 mg twice daily 100mg daily -1 25 mg twice daily 100mg daily 1 50 mg twice daily 100mg daily 2 75 mg twice daily 100mg daily 3 75 mg twice daily 200mg daily 4 75 mg twice daily 300mg daily 5 After the first two cycles of treatment, the dose of Duvelisib will be dropped to 25 mg twice daily irrespective of the starting dose level unless the patient is at dose level -1 then they will stay on that dose level after the initial 2 cycles

Sponsors & Collaborators

  • Secura Bio, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Hayder Saeed, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2024-01-02
Completion
2024-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05065866 on ClinicalTrials.gov