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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bio-Path Holdings, Inc.
Study ID
NCT02781883
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BP1001 in combination with Ventoclax plus decitabine — DRUG
    BP1001 in combination with Ventoclax plus decitabine
  • BP1001 plus decitabine — DRUG
    BP1001 plus decitabine in ventoclax intolerant or resistant subjects

Study Details

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.

Key Dates

First listed
May 25, 2016
Start date
May 31, 2016
Status verified
Mar 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Untreated AML
    BP1001 in combination with Ventoclax plus decitabine
  • Experimental: Refractory/Relapsed AML
    BP1001 in combination with Ventoclax plus decitabine
  • Experimental: Refractory/Relapsed AML (ventoclax-intolerant or resistant)
    BP1001 + decitabine combination in patients who are resistant or intolerant of venetoclax-based treatment, or considered not optimal candidates for a venetoclax-based therapy.

Primary Outcome Measure

Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy [ Time Frame: 180 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
Bruck Habtemariam
[email protected]
310-528-2565
Rika Galias
[email protected]
310-206-5756
Gary Schiller, MD (PRINCIPAL_INVESTIGATOR)
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Vamsi Kota, MD
[email protected]
706-721-2505
Vamsi Kota, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterFairwayKansas66205
Kerry Hepler, RN
[email protected]
913-945-7552
Jecinta Scott, MS
[email protected]
913-945-7505
Tara Lin, MD (PRINCIPAL_INVESTIGATOR)
New Jersey Hematology Oncology AssociatesBrickNew Jersey08724-
Laura & Isaac Pe lmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Mohammad Maher Abdul Hay, MD
[email protected]
646-501-4818
Mohammad Maher Abdul Hay, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical College - New York - Presbyterian HospitalNew YorkNew York10021
Gail J Roboz, MD
[email protected]
646-962-2700
Gail J Roboz, MD (PRINCIPAL_INVESTIGATOR)
University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Maro Ohanian, DO
[email protected]
713-792-2631
Maro Ohanian, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research InstituteTempleTexas76508-
West Virginia University/Mary Babb Randolph Cancer CenterMorgantownWest Virginia26506-

Find similar trials in Los Angeles, CA

By research site
UCLA Medical Center· Los Angeles, CAGeorgia Cancer Center at Augusta University· Augusta, GAUniversity of Kansas Cancer Center· Fairway, KSNew Jersey Hematology Oncology Associates· Brick, NJLaura & Isaac Pe lmutter Cancer Center at NYU Langone Health· New York, NYWeill Cornell Medical College - New York - Presbyterian Hospital· New York, NY

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