Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gemtuzumab Ozogamicin · 2 trials · 1 indication
MTD was determined by testing increasing doses up to 600mg orally daily on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of drug where fewer than 33% of subjects experience a dose limiting toxicity (DLT). DLT is 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); Note: patients who enter the study with grade 3 or worse cytopenias will not be evaluable for hematologic DLT. Non-hematologic toxicity: any grade 3 or worse treatment-related toxicity occurring within the first 56 days.
| Arm | Type | Description |
|---|---|---|
| Arm A: Control Arm without Venetoclax | ACTIVE_COMPARATOR | During Cycle 1 (42-day-cycles), participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. Gemtuzumab 3 mg/m\^2 will be given on Day 6 (only for participants with CD33 expression on leukemia blasts). During Cycle 2 participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy. |
| Arm B: Experimental Arm with Venetoclax | EXPERIMENTAL | During Cycle 1 (42-day-cycles), participants will receive 300 mg adult dose equivalent of venetoclax once on Day 1 followed by 600 mg adult dose equivalent of venetoclax on Days 2-21. Participants will also receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 8-12. Gemtuzumab 3 mg/m\^2 will be given on Day 13 (only for participants with CD33 expression on leukemia blasts). During Cycle 2, participants will receive 600 mg adult dose equivalent of venetoclax on Days 1-21. Participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy in combination with venetoclax. |
| Gemtuzumab Ozogamicin(GO) + Venetoclax | EXPERIMENTAL | Gemtuzumab Ozogamicin(GO) + Venetoclax |
| Name | Type | Description |
|---|---|---|
| Fludarabine | DRUG | Intravenous (IV) infusion |
| Cytarabine | DRUG | Intravenous (IV) infusion |
| Gemtuzumab Ozogamicin | DRUG | Intravenous (IV) infusion |
| Azacitidine | DRUG | Intravenous (IV) infusion or subcutaneous injection |
| Venetoclax | DRUG | Orally via tablet or powder suspension |
Inclusion Criteria * Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/Blood Cancer United territory). * Participants must be ≥ 29 days of age and ≤ 21...
Gemtuzumab Ozogamicin is used for Acute Myeloid Leukemia (AML). It is an antibody-drug conjugate being studied in combination with venetoclax for patients with relapsed or refractory CD33+ AML, and in pediatric patients with relapsed AML. It is currently in Phase 3 clinical development.
Gemtuzumab Ozogamicin targets CD33, a protein expressed on leukemic cells. It is an antibody-drug conjugate that delivers a cytotoxic agent to CD33-positive cells. The drug is being evaluated in biomarker-selected patients with CD33+ Acute Myeloid Leukemia.
Gemtuzumab Ozogamicin is developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials of the drug in Acute Myeloid Leukemia, including a Phase 3 study in pediatric patients with relapsed AML.
Gemtuzumab Ozogamicin is in Phase 3 clinical development for Acute Myeloid Leukemia. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and one Phase 3 trial is currently recruiting participants.
Gemtuzumab Ozogamicin is being studied in two clinical trials. NCT04070768 is a completed Phase 1 study of gemtuzumab ozogamicin with venetoclax in relapsed or refractory CD33+ AML. NCT05183035 is a recruiting Phase 3 study of venetoclax in children with relapsed AML.
Yes, Gemtuzumab Ozogamicin is commonly abbreviated as GO. In clinical trials, it is referred to as GO, such as in the study title 'Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia.'