Venetoclax + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySean Quigley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: John Quigley

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase Ib Study to determine the Maximum Tolerated Dose (MTD) of Venetoclax in combination with Gemtuzumab Ozogamicin(GO) in subjects with relapsed/refractory acute myeloid leukemia. Using a standard 3+3 design, subjects will receive once cycle of combination therapy. After one cycle of combination therapy, subjects showing response will continue on to one cycle of consolidation therapy with GO\\Veneoclax. Subjects who respond to combination therapy will continue on maintenance Venetoclax until progression or unacceptable toxicity. Dose-limiting toxicity, defined as an adverse event related (possible, probably, or definite) to Venetoclax and/or Gemtuzumab fulfilling one of the following criteria: criteria: * Hematologic toxicity: treatment-related grade 3 or worse neutropenia and/or thrombocytopenia due to bone marrow hypocellularity present at the end of cycle one (day 28) with an additional 28 days allowed for count recovery (i.e. present at day 56); specifically grade 3 or worse neutropenia or thrombocytopenia with the bone marrow documented to be free of leukemic infiltration. Note: patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic dose-limiting toxicities. * Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity occurring within the first cycle (excluding grade 3-4 infections during cycle one). The study will also evaluate the Overall Response Rate, Anti-leukemic activity, Relapse-free Survival (RFS), event-free survival (EFS) , and overall survival (OS). The study will evaluate quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).

Eligibility Criteria

Adults aged 18-75 with relapsed or refractory acute myeloid leukemia (AML) that expresses CD33 on at least 20% of blasts. They must have an ECOG Performance Status of 0-2, not be pregnant, and agree to use contraception. Exclusions include a history of certain blood disorders, uncontrolled infections, recent other cancer treatments, HIV positivity, CNS AML involvement, prior stem cell transplant within two months or previous treatment with the study drugs unless specific conditions are met.

Inclusion Criteria

I am willing to use effective birth control during and after my treatment.

I am not pregnant and can prove it with a test taken in the last week.

I am between 18 and 75 years old.

+7 more

Exclusion Criteria

I do not have an active severe infection or it is under control.

I cannot take medications by mouth due to a digestive condition.

I don't have ongoing major side effects from cancer treatment.

+19 more

Participant Groups

The trial is testing the combination of Venetoclax and Gemtuzumab Ozogamicin (GO) to find the highest dose patients can take without severe side effects in those with AML. Participants will receive one cycle of therapy followed by consolidation if they respond well. Responders continue maintenance therapy until disease progression or unacceptable toxicity occurs.

1Treatment groups

Experimental Treatment

Group I: Gemtuzumab Ozogamicin(GO) + VenetoclaxExperimental Treatment2 Interventions

Gemtuzumab Ozogamicin(GO) + Venetoclax

Gemtuzumab Ozogamicin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Mylotarg for: