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

Recruiting now · Phase 2

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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 facts

Study ID

NCT02781883

Run by

Bio-Path Holdings, Inc.

People needed

108

Starts

2016-05-01

Expected to finish

2028-12-01

Last updated by the study team

2025-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
• Adults ≥18 years of age
• Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine
• Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine
• Histologically documented diagnosis (based on the 2008 World Health Organization [WHO] Classification) (Vardiman et al. 2009) of one of the following:
• Newly diagnosed untreated AML; or
• Untreated secondary AML, including AML that has progressed from MDS
• In some cases of AML associated with specific genetic abnormalities, however, the diagnosis of AML may be made if the blast count is less than 20% (Dohner et al. 2017) - specifically AML with t(15;17), t(8;21), inv(16), or t(16;16))
• Relapsed or Refractory AML
• Investigator considers previously untreated participant ineligible for (or unwilling to receive) intensive induction therapy based on medical reasons, disease characteristics such as genetics, type of AML (untreated or secondary), or participant characteristics such as age, performance status, co-morbidities, organ dysfunctions, or patient election of low-intensity treatment
• Eligible for venetoclax and decitabine therapy, based on Investigator assessment
• Participant's WBC count is 25 x 10\^9/L or less at study initiation. The use of leukapheresis or hydroxyurea before treatment initiation to achieve this is permitted.
• Adequate hepatic and renal functions as defined by:
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
• Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path holdings. And;
• Estimated glomerular filtration rate (eGFR) of at least 40 ml/min. These estimations can be calculated using any of the following methods (Appendix E: Formulas):
• i. Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
• GFR = 141 × min (Scr /κ, 1)\^α × max(Scr /κ, 1)\^-1.209 × 0.993\^Age × 1.018 [if female] × 1.159 [if black] ii. Cockcroft gault equation
• Cockcroft Gault equation utilizing the TBW (Total body weight) to calculate an estimated creatinine clearance
• CrCl = [(140 - age) x TBW] / (Scr x 72) x 0.85 [if female] iii. Modification of Diet in Renal Disease (MDRD) Study equation
• GFR (mL/min/1.73 m\^2) = 175 × (Scr)\^-1.154 × (Age)\^-0.203 × 0.74 [if female] x 1.212 [if African American (AA)] iv. Creatinine clearance estimated by 24-hr urine collection for creatinine clearance
• Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
• Willing and able to provide written informed consent 7.2. Exclusion Criteria
• At the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:

Where it is running

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

Full record on ClinicalTrials.gov

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