Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
Public ClinicalTrials.gov record NCT02781883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02781883
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2016
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2028
- Last update posted
- Mar 6, 2025
2016 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | Recruiting |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | Recruiting |
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | Recruiting |
| New Jersey Hematology Oncology Associates | Brick | New Jersey | 08724 | Terminated |
| Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | Recruiting |
| Weill Cornell Medical College - New York - Presbyterian Hospital | New York | New York | 10021 | Recruiting |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Baylor Scott & White Research Institute | Temple | Texas | 76508 | Terminated |
| West Virginia University/Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | Terminated |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02781883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02781883 live on ClinicalTrials.gov.