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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

  • Status Recruiting
    Recruiting
  • Condition Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phas...
    Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phas...
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Ruxolitinib, Drug: Enasidenib

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: Ruxolitinib, Drug: Enasidenib

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Mayo Clinic - Arizona, Scottsdale, Arizona, 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.

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

  • Status Recruiting
    Recruiting
  • Condition Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
    Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Enasidenib, Drug: Enasidenib Mesylate

Eligibility
  • Ages: 24 to 18 Months (Child)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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

  • Status Recruiting
    Recruiting
  • Condition Previously Untreated Acute Myeloid Leukemia
    Previously Untreated Acute Myeloid Leukemia
  • Phase Phase 1 Phase 2
    Phase 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 Group 1), Drug: Decitabine (BAML-16-001-S8 Group 1), 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), Drug: Decitabine (BAML-16-001-S8 Group 2), Drug: Venetoclax (BAML-16-001-S8 Group 2), Drug: AZD5991 (BAML-16-001-S18), Drug: Azacitidine (BAML-16-001-S18)

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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 Group 1), Drug: Decitabine (BAML-16-001-S8 Group 1), 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), Drug: Decitabine (BAML-16-001-S8 Group 2), Drug: Venetoclax (BAML-16-001-S8 Group 2), Drug: AZD5991 (BAML-16-001-S18), Drug: Azacitidine (BAML-16-001-S18)

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.

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)

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Leukemia, Myeloid, Acute
    Leukemia, Myeloid, Acute
  • Phase Phase 1 Phase 2
    Phase 1 Phase 2
INTERVENTION

Drug: AG-120, Drug: Azacitidine, Drug: AG-221

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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.

Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

  • Status Recruiting
    Recruiting
  • Condition Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucle...
    Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucle...
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Azacitidine, Drug: Enasidenib, Other: Quality-of-Life Assessment

Eligibility
  • Ages: 12 Years and older (Child, Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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)

  • Status Recruiting
    Recruiting
  • Condition Relapsed Refractory Multiple Myeloma
    Relapsed Refractory Multiple Myeloma
  • Phase Phase 1 Phase 2
    Phase 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, Drug: Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Drug: Selinexor, dexamethasone, ixazomib, pomalidomide

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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, Drug: Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Drug: Selinexor, 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 25% 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 25% 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 Perpetrator Drug Interactions of Enasidenib in AML Patients

  • Status Recruiting
    Recruiting
  • Condition Leukemia, Myeloid, Acute
    Leukemia, Myeloid, Acute
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: enasidenib, Drug: Arm 1 probes, Drug: Arm 2 Probes, Drug: Arm 3 probes

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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).

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

  • Status Recruiting
    Recruiting
  • Condition Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blas...
    Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blas...
  • Phase Phase 3
    Phase 3
INTERVENTION

Drug: AG-120, Drug: Placebo for AG-120, Drug: AG-221, Drug: Placebo for AG-221

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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

EE-Tartu-TARTU, Tartu, Estonia

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.

IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT

  • Status Recruiting
    Recruiting
  • Condition Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Chronic Myel...
    Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Chronic Myel...
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: Enasidenib

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
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.

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

  • Status Recruiting
    Recruiting
  • Condition Hepatic Impairment
    Hepatic Impairment
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: Enasidenib

Eligibility
  • Ages: 40 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: Enasidenib

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Miami Miller School of Medicine, Miami, Florida, United States

Brief Summary

This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease. Subjects will be enrolled in 4 Groups as follows: - Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of < 7) will be enrolled in Group A. - Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B. - Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C. - Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.