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Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL

NCT04803123 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-12-21

No results posted yet for this study

Summary

This study will provide an evaluation of biologic markers of leukemia cell response following a single dose of copanlisib prior to any salvage induction therapy in a projected cohort of 10 relapsed/refractory B-ALL patients.

Conditions

  • Leukemia, Acute Lymphocytic

Interventions

DRUG

Copanlisib

Patients must receive at least one dose of copanlisib prior to standard therapy to be evaluable.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Dorothy Sipkins, MD, PhD

    lead OTHER

Principal Investigators

  • Dorothy Sipkins, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2023-04-03
Completion
2023-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04803123 on ClinicalTrials.gov