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IDH2 Inhibitor
Enasidenib for Chronic Myelomonocytic Leukemia
Phase 1 & 2
Waitlist Available
Led By Tian Yi Zhang, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing enasidenib to see if it can help patients with certain blood disorders make more red blood cells and need fewer transfusions. The medication works by boosting the body's natural ability to produce red blood cells. Enasidenib is approved by the US FDA for adults with specific types of blood cancer.
Who is the study for?
This trial is for adults with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML), without IDH2 mutation, who have anemia symptoms like fatigue and shortness of breath. Participants must not have had certain therapies recently, be able to take oral meds, and use effective contraception if applicable. They can't join if they have other causes of anemia, significant heart disease, less than 3 months life expectancy, active infections including HIV or hepatitis B/C.
What is being tested?
The study tests whether enasidenib mesylate can safely improve anemia and reduce the need for blood transfusions in MDS/CMML patients without the IDH2 mutation. It's a phase 1b/2 trial where everyone gets increasing doses of enasidenib to see how well it works and what effects it has on their body.
What are the potential side effects?
Possible side effects from enasidenib may include digestive issues such as nausea or vomiting, liver problems indicated by changes in blood tests, tiredness, decreased appetite or weight loss. Since this is a dose escalation study assessing safety too, close monitoring will occur to identify any new or unexpected side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Response: Hematological Improvement - Erythroid (HI-E)
Clinical Response: Hematological Improvement - Neutrophils (HI-N)
Clinical Response: Hematological Improvement - Platelets (HI-P)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enasidenib mesylatExperimental Treatment1 Intervention
Participants will self administer the enasidenib orally everyday.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for leukemia often target specific genetic mutations or dysregulated molecular pathways involved in the disease. For instance, Enasidenib inhibits the mutant IDH2 enzyme, which is crucial in blocking the differentiation of hematopoietic cells, thereby promoting the maturation of malignant cells.
This mechanism is significant for leukemia patients as it directly addresses the underlying genetic abnormalities driving the disease, potentially leading to more effective and targeted therapies. Other treatments, such as those targeting DNA methylation or signal transduction pathways, work by correcting the epigenetic and signaling abnormalities that contribute to leukemia progression.
These targeted approaches are essential as they offer the potential for more precise and less toxic treatments compared to traditional chemotherapy.
Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic <i>IDH2</i> Mutations.
Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.AG-221, a First-in-Class Therapy Targeting Acute Myeloid Leukemia Harboring Oncogenic <i>IDH2</i> Mutations.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,085 Total Patients Enrolled
42 Trials studying Leukemia
11,843 Patients Enrolled for Leukemia
Tian Yi ZhangLead Sponsor
Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,642 Total Patients Enrolled
82 Trials studying Leukemia
2,654 Patients Enrolled for Leukemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have anemia caused by factors like low levels of iron, vitamin B12, or folate, or nutritional issues related to certain surgeries, eating disorders, or excessive zinc intake. If these nutritional deficiencies can be fixed, you can be re-evaluated and potentially enrolled in the study if you are no longer deficient and still meet the other requirements.You have used other medications that help produce red blood cells or boost the immune system within the past month.You have been given less than 3 months to live.
Research Study Groups:
This trial has the following groups:- Group 1: Enasidenib mesylat
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