Olutasidenib Combination Therapy for Blood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new drug combinations to determine their safety and tolerability for individuals with certain types of blood cancer that have returned or not responded to treatment. The focus is on patients with specific mutations in their cancer cells, including the IDH1 mutation. Participants will receive different combinations of the drug Olutasidenib (a targeted therapy) with other medications such as Cladribine, Cytarabine, Gilteritinib, Venetoclax, and Ruxolitinib. This trial may suit those with relapsed or resistant acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) who have specific genetic mutations identified by their doctors. As a Phase 2 trial, the 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 a break from previous treatments for at least 14 days or five half-lives before starting the study drug, except for certain medications like hydroxyurea and cytarabine, which are allowed under specific conditions. It's best to discuss your current medications with the study team to understand how they might be affected.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that olutasidenib is generally well-tolerated by patients. The FDA has already approved it for treating a specific type of blood cancer, indicating its safety for at least one condition. However, its safety profile can change when combined with other drugs. For instance, when olutasidenib is used with cladribine and cytarabine, leukopenia was the most common side effect, affecting about 62.1% of patients.
When combined with gilteritinib, some studies found that fewer than half of the patients experienced serious side effects, such as decreases in red blood cells and platelets. The combination with ruxolitinib is still under study, but serious side effects occurred in about 73% of patients who had previous treatments.
These findings suggest that while significant side effects can occur, many patients tolerate the drugs. Each drug combination may have different effects, so discussing any concerns with a healthcare provider can help determine if joining a trial is appropriate.12345Why are researchers excited about this trial's treatments?
Researchers are excited about olutasidenib combination therapies for blood cancer because they target cancer cells in new ways compared to standard treatments. While most current treatments focus on broad approaches like chemotherapy, olutasidenib is combined with other drugs to specifically target genetic mutations in cancer cells. For instance, combining olutasidenib with drugs like cladribine, cytarabine, and venetoclax aims to enhance the killing of cancer cells that have specific mutations. Additionally, pairing olutasidenib with gilteritinib or ruxolitinib may offer new ways to tackle cancer by inhibiting pathways that help cancer cells survive. This targeted approach has the potential to improve outcomes and reduce side effects compared to traditional chemotherapy.
What evidence suggests that this trial's treatments could be effective for blood cancer?
Research has shown that olutasidenib can effectively treat certain blood cancers, such as acute myeloid leukemia (AML), particularly when combined with other medications. In this trial, participants may receive different combinations involving olutasidenib. One arm will test olutasidenib with cladribine and cytarabine, while another will include venetoclax in the combination. Studies have demonstrated that such combinations can achieve a 94% complete response rate. Another arm will evaluate olutasidenib with gilteritinib, which has improved overall survival compared to other treatments. Additionally, this trial includes an arm testing olutasidenib combined with ruxolitinib, which has shown promising results for patients with specific types of blood cancer. These findings suggest that combinations involving olutasidenib could benefit patients with blood cancers that have returned or are resistant to other treatments, especially those with certain genetic changes.12467
Who Is on the Research Team?
Courtney DiNardo, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with relapsed/refractory IDH1-mutated myeloid malignancies and additional signaling mutations, who have adequate organ function and performance status. Excluded are those with severe heart or psychiatric conditions, uncontrolled medical issues, high white cell count without treatment options, pregnant or breastfeeding women not using contraception, prior olutasidenib use, certain leukemia types, absorption-impairing conditions, allergies to study drugs, or active viral infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with Olutasidenib in combination with co-targeted therapies such as Cladribine, Cytarabine, Venetoclax, Gilteritinib, and Ruxolitinib
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Olutasidenib
- Ruxolitinib
- Venetoclax
Trial Overview
The trial is testing the safety of combining Olutasidenib with other targeted therapies (Venetoclax, Cladribine (CLAD), Gilteritinib, Cytarabine, Ruxolitinib) in patients whose myeloid malignancies have both IDH1 mutations and activated signaling pathway mutations. The goal is to determine how well these drug combinations are tolerated.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Treatment with Olutasidenib + Ruxolitinib
Treatment with Olutasidenib + Gilteritnib + Venetoclax
Treatment with Olutasidenib + Gilteritnib
Treatment with Olutasidenib + Cladribine + Cytarabine + Venetoclax
Treatment with Olutasidenib + Cladribine + Cytarabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Rigel Pharmaceuticals
Industry Sponsor
Citations
Study Details | NCT07032727 | Olutasidenib Combined ...
Primary Objectives. To determine the safety and tolerability of olutasidenib in combination with cladribine + LDAC ± venetoclax (Arm 1), ...
Combination therapy with novel agents for acute myeloid ...
For decades, combination chemotherapy with an anthracycline and cytarabine has formed the backbone of therapy for acute myeloid leukaemia (AML), for example, ...
Olutasidenib Combination Therapy for Blood Cancer
Trial Overview The trial is testing the safety of combining Olutasidenib with other targeted therapies (Venetoclax, Cladribine (CLAD), Gilteritinib, Cytarabine ...
A ray of hope in the treatment of acute myeloid leukaemia
Olutasidenib was approved on December 1, 2022, by FDA with the brand name Rezlidhea as one of the effective treatments against acute myeloid leukaemia via ...
Olutasidenib with Co-targeted Therapy in Relapsed or ...
This clinical trial aims to explore the safety and effectiveness of a new treatment combination for people with certain types of blood cancers that have ...
Olutasidenib for mutated IDH1 acute myeloid leukemia
Overall response rate was 48% (95% CI: 40, 56.7), with median duration 15.5 mo (95% CI: 7.4, 26.2) and maximum duration 54.6 mo. Median overall ...
(PDF) Efficacy and safety of cladribine, low-dose ...
Efficacy and safety of cladribine, low-dose cytarabine and venetoclax in relapsed/refractory acute myeloid leukemia: results of a pilot study.
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