Olutasidenib + Azacitidine for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination treatment for people with acute myeloid leukemia (AML) that has a specific genetic change called an IDH1 mutation. The study aims to determine if two drugs, olutasidenib (a new potential drug) and azacitidine, can stop cancer cells from growing and prevent the leukemia from returning. It suits those with AML and an IDH1 mutation who have already received venetoclax and a hypomethylating agent and are candidates for azacitidine treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires participants to stop taking venetoclax at least 1 week before starting the study treatment. Other medications known to cause certain heart issues must also be stopped before the trial. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of olutasidenib and azacitidine is generally well-tolerated by patients. Studies have found that this treatment typically causes mild side effects that can be managed. Most side effects are not severe and can be controlled.
In earlier studies with patients who have certain types of leukemia, many responded well to the treatment, experiencing significant improvements without major issues. For example, one study found that patients had high response rates and long-lasting periods of cancer inactivity.
Overall, olutasidenib, whether used alone or with azacitidine, has been linked to positive results in terms of safety and effectiveness. It is important to remember that while the treatment is generally safe, some patients may still experience side effects. Always discuss these possibilities with a healthcare provider.12345Why are researchers excited about this study treatment for AML?
Unlike standard treatments for acute myeloid leukemia (AML), which often include chemotherapy and other traditional cancer drugs, the combination of olutasidenib and azacitidine introduces a novel approach. Olutasidenib is a targeted therapy that disrupts a specific mutation in cancer cells, offering a more precise attack on the disease. This treatment pairing also allows for oral administration of olutasidenib, potentially making the regimen more convenient for patients compared to solely intravenous options. Researchers are excited because this combination could offer better outcomes with possibly fewer side effects by honing in on the genetic drivers of the cancer.
What evidence suggests that olutasidenib with azacitidine might be an effective treatment for acute myeloid leukemia?
Research has shown that using olutasidenib with azacitidine, the combination studied in this trial, might effectively treat IDH1-mutated acute myeloid leukemia (AML). Studies have found that this combination can lead to high rates of positive responses and long-lasting periods without the disease in patients whose AML has returned or did not respond to previous treatments. In one study, olutasidenib helped 35% of patients achieve complete remission, with no signs of cancer, and 48% had an overall positive response. Additionally, most patients tolerate the side effects well. Early results suggest this treatment could be a promising option for patients who have already tried other treatments, such as venetoclax with a hypomethylating agent.12678
Who Is on the Research Team?
Brian Jonas, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for adults with IDH1-mutated acute myeloid leukemia (AML) who've had less than or equal to 4 cycles of treatment with HMA-Ven. They should have an ECOG performance status ≤2, a creatinine clearance ≥40 mL/min, and must have responded to initial HMA-Ven therapy. People can't join if they've had a solid organ transplant or haven't recovered from previous treatments' side effects.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olutasidenib orally twice daily and azacitidine intravenously or subcutaneously for seven days of each cycle. Cycles repeat every 28 days for up to 4 cycles.
Maintenance
Participants receive olutasidenib orally twice daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs within 30 days and then every 4 months.
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Olutasidenib
Trial Overview
The study tests olutasidenib combined with azacitidine followed by maintenance olutasidenib in patients previously treated with venetoclax plus a hypomethylating agent. It's designed to see if this combination helps control AML growth after the first line of treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive olutasidenib PO BID on days 1-28 of each cycle and azacitidine IV or SC for seven days of each cycle as per schedule determined by investigator. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
1.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/2886/533189/Combination-of-Olutasidenib-and-AzacitidineCombination of Olutasidenib and Azacitidine Induces Durable ...
Results: Sixty-seven patients with R/R mIDH1R132 AML received combination OLU+AZA after a median 10.2 months since AML diagnosis; 43% were ...
Olutasidenib in combination with azacitidine induces ...
Olutasidenib plus azacitidine induced high response rates and durable remissions with a tolerable side effect profile in patients with R/R AML ...
3.
targetedonc.com
targetedonc.com/view/final-5-year-data-confirm-olutasidenib-s-durability-and-safety-in-midh1-amlFinal 5-Year Data Confirm Olutasidenib's Durability and ...
Olutasidenib showed a 35% complete remission rate and 48% overall response rate in relapsed/refractory mutant IDH1 AML patients, with a median ...
Outcomes of Patients with IDH1-Mutated Myeloid ...
Olutasidenib resulted in 100% response rates in 4 previously untreated IDH1-mutated AML and MDS, but efficacy was modest in heavily pretreated R ...
A phase 2 study of olutasidenib in relapsed/refractory acute ...
Higher response rates (including CR and CRh) and greater survival were observed in patients receiving OLU following 1-2 versus ≥3 prior treatment regimens.
a multicohort open-label phase 1/2 trial - PubMed - NIH
Conclusions: Olutasidenib plus azacitidine induced high response rates and durable remissions with a tolerable side effect profile in patients ...
Olutasidenib alone or combined with azacitidine in patients ...
Olutasidenib alone or with azacitidine elicited high response rates and durable remissions in intermediate- to very high-risk mIDH1 MDS. · The ...
Rigel Announces Publication of Early Clinical Data ...
The published data suggest that olutasidenib, with or without azacitidine, was well-tolerated and was associated with improvements in clinical efficacy ...
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