Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT04070768
- Lead Sponsor
- John Quigley
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gemtuzumab Ozogamicin(GO) + Venetoclax Gemtuzumab Ozogamicin Gemtuzumab Ozogamicin(GO) + Venetoclax Gemtuzumab Ozogamicin(GO) + Venetoclax Venetoclax Gemtuzumab Ozogamicin(GO) + Venetoclax
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of Venetoclax when administered with GO 42 days Assess the maximum tolerated dose (MTD) of Venetoclax when administered with GO in patients with AML.
-Dose-limiting toxicity, defined as an adverse event related (possible, probably, or definite) to Venetoclax and/or Gemtuzumab fulfilling one of the following 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).
- Secondary Outcome Measures
Name Time Method Rate of Anti-leukemic activity 7 months Anti-leukemic activity (CR/Cri/PR), as defined by the revised IWG criteria
Relapse-free survival 7 months patients achieving CR or CRi; measured from the date of achievement of a remission until the date of relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last examined
Overall response rate 7 months Overall response rate (CR/CRi), as defined by the revised IWG criteria
Event-free Survival 7 months Event-free Survival will be measured from the date of entry to the date of treatment failure, disease relapse, or death from any cause; patients not known to have any of these events are censored on the date they were last examined
overall survival 7 months Overall survival will be measured from the date of entry to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
Trial Locations
- Locations (4)
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
🇺🇸Indianapolis, Indiana, United States
Univeristy of Illinois
🇺🇸Chicago, Illinois, United States