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Trial Title:
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
NCT ID:
NCT06465953
Condition:
Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)
Myelodysplastic Syndromes (MDS)
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Ivosidenib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ivosidenib
Description:
Two 250 mg tablets, totaling 500 mg, administered orally once daily until disease relapse
or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death,
withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs
first.
Arm group label:
Ivosidenib monotherapy
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
Azacitidine 75mg/m^2/day administered by subcutaneous (SC) or intravenous (IV) injection
for 1 week (7 days) of each 4-week (28 day) treatment cycle until disease relapse or
progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death,
withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs
first.
Arm group label:
Azacitidine monotherapy
Summary:
This study will enroll participants with myelodysplastic syndromes (MDS) with an
Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with
a hypomethylating agent previously. Participants will be randomized to receive either
ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily
throughout the 28-day treatment cycle and AZA will be administered for the first 7 days
of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1,
8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment,
participants will attend an safety follow-up visit and participants will be followed to
assess overall survival. Study visits may include a bone marrow aspirate, physical exam,
echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and
questionnaires.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th
edition):
- Moderate high, high and very high-risk MDS per IPSS-M score will be eligible
regardless of blood counts and with blast counts 0-19%.
- Low and moderate low-risk MDS per IPSS-M score must:
- Have cytopenias related to MDS, defined as: <100 platelets/microliter, or absolute
neutrophil count (ANC) <1000/mm3, or hemoglobin <10g/dL AND
- Have a blast count between 5-19% AND
- Be eligible for HMA therapy (very low risk participants are to be excluded)
- Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation
Exclusion Criteria:
- Received prior anticancer/disease modifying treatment for MDS (including HMA's,
cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens,
hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients,
prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are
allowed.
- >20% blasts by morphology or immunohistochemistry on screening bone marrow
aspirate/biopsy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 30, 2024
Completion date:
December 1, 2028
Lead sponsor:
Agency:
Institut de Recherches Internationales Servier
Agency class:
Other
Collaborator:
Agency:
Servier Bio-Innovation LLC
Agency class:
Industry
Source:
Servier
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465953
