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Clinical Trial of BP1001 with Venetoclax and Decitabine for AML

This study is testing BP1001 in combination with venetoclax plus decitabine for people with Acute Myeloid Leukemia (AML). Researchers want to see if this combination works better than venetoclax plus decitabine alone for newly diagnosed AML patients who can't have strong chemotherapy. They also want to see if BP1001-based treatment is better than intensive chemotherapy for AML that has come back or didn't respond to previous treatment. BP1001 is designed to stop a protein called Grb2, which may help leukemia cells grow. By blocking Grb2, the hope is that leukemia cells will die. The study is open to adults aged 18 and older. Success will be measured by how many patients achieve complete remission (when signs of cancer disappear) within 180 days.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 108 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Efficacy will be assessed at 180 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02781883

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bio-Path Holdings, Inc.
~108 participants
Updated 2025-03-07 on ClinicalTrials.gov
What's tested:BP1001 in combination with Ventoclax plus decitabineBP1001 plus decitabine

At a glance

Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy
Measured over 180 days
+1 more outcome measured

Conditions

Acute Myeloid Leukemia (AML)

Explore related trials

Acute Myeloid Leukemia

Where it's being run

9 sites across 7 states
New York2
Texas2
California1
Georgia1
Kansas1
New Jersey1
West Virginia1

Study leadership

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

Who to contact

Maro Ohanian, DO
[email protected]
713-792-2631
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 9. Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 10. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment

What this trial measures

  • Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy180 days

    Assess whether the combination of BP1001 and Ventoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than Ventoclax + decitabine alone (by historical comparison) with untreated AML that cannot or elect not to be treated with more intensive chemotherapy

  • Assessment of efficacy in refractory/relapsed AML subjects by bone marrow aspirate or biopsy180 days

    Assess whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.