Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03471260
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myeloid Leukemia
  • Hematopoietic and Lymphoid System Neoplasm
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given IV or SC
  • Ivosidenib — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.

Key Dates

Start date
Mar 19, 2018
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, ivosidenib, azacitidine)
    Patients receive venetoclax PO daily on days 1-14. Patients also receive ivosidenib PO daily on days 15-28 of cycle 1 and days 1-28 of subsequent cycles. Patients may also receive azacitidine IV over 30-60 minutes or SC on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 3 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jacqueline S. Garcia, MD
[email protected]
617-632-2168
Jacqueline S. Garcia, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195
Hetty Carraway, MD
[email protected]
216-445-5899
Hetty Carraway, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Curtis Lachowiez, MD
[email protected]
503-346-0010
Curtis Lachowiez, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Courtney DiNardo
[email protected]
713-794-1141
Courtney DiNardo (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana-Farber Cancer Institute· Boston, MACleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHOregon Health and Science University· Portland, ORM D Anderson Cancer Center· Houston, TX

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