Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

Description

The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.

Conditions

Acute Myeloid Leukemia (AML)

Study Overview

Study Details

Study overview

The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.

A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy

Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

Condition
Acute Myeloid Leukemia (AML)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

Augusta

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States, 30912

Fairway

University of Kansas Cancer Center, Fairway, Kansas, United States, 66205

Brick

New Jersey Hematology Oncology Associates, Brick, New Jersey, United States, 08724

New York

Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health, New York, New York, United States, 10016

New York

Weill Cornell Medical College - New York - Presbyterian Hospital, New York, New York, United States, 10021

Houston

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States, 77030

Temple

Baylor Scott & White Research Institute, Temple, Texas, United States, 76508

Morgantown

West Virginia University/Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Bio-Path Holdings, Inc.,

    Maro Ohanian, DO, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

    Study Record Dates

    2024-12