Venetoclax or Gemtuzumab Ozogamicin for AML
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments to determine which is more effective for core binding factor acute myeloid leukemia (CBF-AML). One treatment combines venetoclax, which stops cancer cells from growing, with chemotherapy. The other combines gemtuzumab ozogamicin, which targets and kills cancer cells, with chemotherapy. The trial seeks participants diagnosed with CBF-AML who have not yet received treatment, except for emergency measures like reducing white blood cells. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer treatment.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it allows certain medications like hydroxyurea and erythropoiesis-stimulating agents. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that venetoclax, when combined with azacitidine, possesses a known safety profile. However, serious side effects have been reported. In some studies, 23% of patients experienced fatal reactions, with pneumonia as the most common cause. Despite this, the FDA approved venetoclax for certain patients with acute myeloid leukemia (AML), indicating some confidence in its safety.
Similarly, researchers have studied gemtuzumab ozogamicin for safety. In some cases, patients developed a serious liver condition called veno-occlusive disease (VOD), and unfortunately, some cases were fatal. Despite these risks, gemtuzumab ozogamicin is approved for treating newly diagnosed CD33-positive AML in adults, suggesting it is generally considered safe but with potential serious side effects.
Both treatments carry risks, but their approval for specific conditions provides some assurance of their safety when used correctly.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for acute myeloid leukemia (AML) because they offer promising new ways to tackle the disease. Venetoclax, used in one treatment arm, is a BCL-2 inhibitor that can induce cancer cell death by targeting a specific protein that helps these cells survive. In contrast, gemtuzumab ozogamicin, used in the other arm, is an antibody-drug conjugate specifically targeting the CD33 antigen present on AML cells, delivering a potent chemotherapy directly to the cancer cells. These mechanisms are different from the standard chemotherapy options, offering potential for better outcomes and fewer side effects for patients with AML.
What evidence suggests that this trial's treatments could be effective for CBF-AML?
This trial will compare two treatment regimens for acute myeloid leukemia (AML). Studies have shown that venetoclax, combined with the "7+3" chemotherapy treatment of cytarabine and daunorubicin, effectively treats AML and can lead to complete remission, where no cancer cells are detectable. Participants in this trial may receive this combination. Another group will receive gemtuzumab ozogamicin added to the same "7+3" treatment, which has improved the time patients live without complications after an AML diagnosis. Gemtuzumab targets specific parts of cancer cells to deliver its cancer-fighting drug, helping to improve survival rates. Both treatments offer promising options for addressing acute myeloid leukemia.16789
Who Is on the Research Team?
Celalettin Ustun
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
This trial is for people newly diagnosed with a specific type of acute myeloid leukemia (CBF-AML) who haven't had prior treatment for AML or MDS, except certain urgent therapies. Participants need to have good organ function and be able to perform daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Patients receive either gemtuzumab ozogamicin or venetoclax with cytarabine and daunorubicin as part of the '7+3' regimen
Consolidation/Post-remission Treatment
Patients undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cytarabine
- Daunorubicin Hydrochloride
- Gemtuzumab Ozogamicin
- Venetoclax
Trial Overview
The study compares adding either venetoclax or gemtuzumab ozogamicin to standard chemotherapy (cytarabine and daunorubicin, known as '7+3') in treating CBF-AML. Patients are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive venetoclax orally (PO) once daily (QD) on days 1-11, cytarabine IV, continuously, on days 2-8 and daunorubicin IV on days 2-4 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Gemtuzumab Ozogamicin for Treatment of Acute Myeloid ...
For ND-AML fit for intensive chemotherapy, fractionated doses GO added to cytarabine and daunorubicin chemotherapy improved EFS (17.3 vs. 9.5 months). Dosing of ...
Gemtuzumab ozogamicin in first-line treatment of CBF-AML
Core-binding factor acute myeloid leukemia: long-term outcome of 70 patients uniformly treated with “7+3”. Blood Cancer J. 2022;12:55. Article ...
pan-Canadian Oncology Drug Review Final Clinical ...
Overall, the CGP concludes that there is a net clinical benefit to GO in the management of previously untreated, newly diagnosed individuals ...
Real-World Efficacy and Safety of Gemtuzumab ...
Gemtuzumab ozogamicin plus standard induction chemotherapy “3 + 7″ has been reported to improve outcomes of newly diagnosed intermediate cytogenetic risk AML, ...
5.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(21)00150-6/abstractOutcomes of Adult Acute Myeloid Leukemia Treated With ...
We performed a retrospective analysis of the safety and outcomes of adult patients with newly diagnosed acute myeloid leukemia (AML) treated with GO with ...
6.
ashpublications.org
ashpublications.org/blood/article/130/22/2373/36556/Gemtuzumab-ozogamicin-for-acute-myeloid-leukemiaGemtuzumab ozogamicin for acute myeloid leukemia | Blood
An interim analysis of 142 patients (median age, 61 years) found that 16.2% achieved a CR and another 13.4% achieved a CRp, for an overall CR + ...
Acute and Long-Term Toxicities Associated with ...
As predicted with CD33-targeted therapy, most patients had neutropenia (98%) and thrombocytopenia (99%). However, the incidence of grade 3/4 bleeding events (14 ...
Final report of the efficacy and safety of gemtuzumab ...
In this study, the authors analyzed the efficacy and safety of gemtuzumab ozogamicin (GO) (Mylotarg®), an antibody-targeted chemotherapy for ...
MYLOTARGTM (gemtuzumab ozogamicin) for injection
MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults. 1.2 Relapsed or Refractory CD33-positive AML.
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