RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2016-05
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02781883

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Maro Ohanian, DO
CONTACT
713-792-2631
mohanian@mdanderson.org

Principal Investigator

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

Study Locations (Sites)

UCLA Medical Center
Los Angeles, California, 90095
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
University of Kansas Cancer Center
Fairway, Kansas, 66205
United States
New Jersey Hematology Oncology Associates
Brick, New Jersey, 08724
United States
Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
Weill Cornell Medical College - New York - Presbyterian Hospital
New York, New York, 10021
United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
Baylor Scott & White Research Institute
Temple, Texas, 76508
United States
West Virginia University/Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Bio-Path Holdings, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05
Study Completion Date2024-12

Study Record Updates

Study Start Date2016-05
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Liposomal Grb-2 treatment of AML
  • Liposomal Grb-2 with Venetoclax plus decitabine for AML

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia (AML)