BP1001 + Venetoclax + Decitabine for Acute Myeloid Leukemia

Palo Alto (17 mi)

Overseen byMaro Ohanian, DO

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Bio-Path Holdings, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with untreated Acute Myeloid Leukemia (AML) or relapsed/refractory AML, who can't or choose not to undergo intensive chemotherapy. Participants must have proper liver and kidney function, an ECOG performance status of 0-2, and agree to use contraception. Excluded are those with active leptomeningeal leukemia, recent anti-cancer therapy, potential pregnancy/breastfeeding during the study period, significant concurrent illnesses or infections.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I have a confirmed diagnosis of AML that is new, untreated, relapsed, or refractory.

I am eligible for treatment with venetoclax and decitabine.

Exclusion Criteria

I have leukemia in the fluid around my brain and need spinal injections.

I do not have any serious ongoing health or mental health issues.

I have not had a heart attack, stroke, or similar event in the last 6 months.

I haven't had cancer treatment except for skin cancer in the last year.

My leukemia is present outside the bone marrow without meeting the criteria for acute leukemia in the bone marrow.

I am not pregnant, trying to get pregnant, or breastfeeding.

I have seizures that are not controlled by medication.

I am willing and able to follow study instructions.

I cannot have live vaccines before, during, or after my venetoclax treatment.

I do not have any untreated or uncontrolled infections.

My leukemia is specifically diagnosed as APL with a certain genetic feature.

I have chronic myeloid leukemia.

I do not have active hepatitis B or C, or HIV.

Treatment Details

The trial is testing BP1001 in combination with venetoclax plus decitabine against historical data for efficacy in achieving complete remission in AML patients. It aims to determine if this new treatment combo is more effective than existing treatments for those who cannot receive intensive chemotherapy.

3Treatment groups

Experimental Treatment

Group I: Untreated AMLExperimental Treatment1 Intervention

BP1001 in combination with Ventoclax plus decitabine

Group II: Refractory/Relapsed AML (ventoclax-intolerant or resistant)Experimental Treatment1 Intervention

BP1001 + decitabine combination in patients who are resistant or intolerant of venetoclax-based treatment, or considered not optimal candidates for a venetoclax-based therapy.

Group III: Refractory/Relapsed AMLExperimental Treatment1 Intervention

BP1001 in combination with Ventoclax plus decitabine