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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 10/22/2020.About Bolder Science
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
351,441 studiesin
216 countries
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Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation
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Status
Recruiting
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PhasePhase 2
-
Condition
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
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PhasePhase 2
INTERVENTION
Drug: Enasidenib, Drug: Enasidenib Mesylate
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Brief Summary
This trial studies the side effects of enasidenib and to see how well it works in treating patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for cell growth.
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
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Status
Recruiting
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PhasePhase 1 Phase 2
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Condition
Previously Untreated Acute Myeloid Leukemia
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PhasePhase 1 Phase 2
INTERVENTION
Biological: Samalizumab (BAML-16-001-S1), Biological: BI 836858 (BAML-16-001-S2), Other: Laboratory Biomarker Analysis, Drug: Daunorubicin (BAML-16-001-S1), Drug: Cytarabine (BAML-16-001-S1), Drug: Azacitidine (BAML-16-001-S2), Drug: AG-221 (BAML-16-001-S3), Drug: Azacitidine (BAML-16-001-S3), Drug: Entospletinib (BAML-16-001-S4), Drug: Azacitidine (BAML-16-001-S4), Drug: Entospletinib (BAML-16-001-S5), Drug: Decitabine (BAML-16-001-S5), Drug: Entospletinib (BAML-16-001-S6), Drug: Daunorubicin (BAML-16-001-S6), Drug: Cytarabine (BAML-16-001-S6), Drug: Pevonedistat (BAML-16-001-S9), Drug: Azacitidine (BAML-16-001-S9), Drug: AG-120 (BAML-16-001-S16), Drug: Azacitidine (BAML-16-001-S16), Drug: Gilteritinib (BAML-16-001-S8), Drug: Decitabine (BAML-16-001-S8), Drug: Acalabrutinib (BAML-16-001-COV1), Other: Standard Therapy (BAML-16-001-COV1), Drug: AZD5153 (BAML-16-001-S10), Drug: Venetoclax (BAML-16-001-S10), Drug: TP-0903 (BAML-16-001-S14), Drug: Decitabine (BAML-16-001-S14)
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
Brief Summary
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation
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Status
Not yet recruiting
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PhasePhase 2
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Condition
Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phas...
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PhasePhase 2
INTERVENTION
Drug: Ruxolitinib, Drug: Enasidenib
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Taussig Cancer Center Institute, Cleveland, Ohio, United States
Brief Summary
The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.
A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)
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Status
Active, not recruiting
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PhasePhase 1 Phase 2
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Condition
Leukemia, Myeloid, Acute
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PhasePhase 1 Phase 2
INTERVENTION
Drug: AG-120, Drug: Azacitidine, Drug: AG-221
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
City of Hope, Duarte, California, United States
Brief Summary
This Phase 1b/2 study is an open-label, randomized, multicenter trial to evaluate the safety and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and a Phase 2 randomized stage.
IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT
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Status
Recruiting
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PhasePhase 2
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Condition
IDH2 Gene Mutation, IDH2 R140, Leukemia, Myeloid, Acute, Myelodys...
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PhasePhase 2
INTERVENTION
Drug: Enasidenib
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
University Hospital Duesseldorf Dept. of Hematology, Oncology and Clinical Immunology, Duesseldorf, NRW, Germany
Brief Summary
This is a prospective, open label, multi-centre phase II trial with a two-arm non comparative design aiming to evaluate the safety and efficacy of Enasidenib (investigational product) as prophylactic consolidation in patients with IDH2-mutated MDS, CMML and AML in remission after allo-SCT and as salvage therapy in patients with IDH2-mutated MDS, CMML and AML who have relapsed after allo-SCT.
A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients
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Status
Recruiting
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PhasePhase 1
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Condition
Leukemia, Myeloid, Acute
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PhasePhase 1
INTERVENTION
Drug: enasidenib, Drug: Arm 1 probes, Drug: Arm 2 Probes, Drug: Arm 3 probes
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Brief Summary
This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation. The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2). Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2).
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
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Status
Recruiting
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PhasePhase 2
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Condition
Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucle...
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PhasePhase 2
INTERVENTION
Drug: Azacitidine, Drug: Enasidenib, Other: Quality-of-Life Assessment
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Brief Summary
This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Myeloma-Developing Regimens Using Genomics (MyDRUG)
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Status
Recruiting
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PhasePhase 1 Phase 2
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Condition
Relapsed Refractory Multiple Myeloma
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PhasePhase 1 Phase 2
INTERVENTION
Drug: Abemaciclib, dexamethasone, ixazomib, pomalidomide, Drug: Enasidenib, dexamethasone, ixazomib, pomalidomide, Drug: Cobimetinib, dexamethasone, ixazomib, pomalidomide, Drug: Erdafitinib, dexamethasone, ixazomib, pomalidomide, Drug: Venetoclax, dexamethasone, ixazomib, pomalidomide, Drug: Daratumumab, dexamethasone, ixazomib, pomalidomide
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Mayo Clinic - Arizona, Phoenix, Arizona, United States
Brief Summary
The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy
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Status
Recruiting
-
PhasePhase 3
-
Condition
Myelodysplastic Syndrome With Excess Blasts-2, Acute Myeloid Leuk...
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PhasePhase 3
INTERVENTION
Drug: AG-120, Drug: Placebo for AG-120, Drug: AG-221, Drug: Placebo for AG-221
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Erasmus MC, Rotterdam, Netherlands
Brief Summary
AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.
Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers
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Status
Not yet recruiting
-
PhasePhase 1 Phase 2
-
Condition
Acute Myeloid Leukemia, Relapsed Cancer, Refractory Cancer, IDH2 ...
-
PhasePhase 1 Phase 2
INTERVENTION
Drug: Enasidenib, Drug: Venetoclax
Eligibility
- Ages:
- Sexes: All
- Accepts Healthy Volunteers:
Locations
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Brief Summary
The purpose of this research study is to see how safe and tolerable, and to find the highest or best dose, of an investigational combination of drugs called enasidenib and venetoclax, in patients with relapsed (the cancer has come back) or refractory (the cancer does not respond or have stopped responding to treatment) acute myeloid leukemia (AML, a type of blood cancer). This study will also see how useful the combination of enasidenib and venetoclax is in the treatment of patients with relapsed or refractory AML.
- Trial Phase
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