TriangleNCT02719574 · CITED IN SOURCE DOCUMENTS
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2026-06-29
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
Phase 1: Area Under the Curve (AUClast) for FT-2102
Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Phase 1: Time to Response (TTR) for AML
Phase 1: Duration of Overall Response for AML
Phase 1: Time to Response (TTR ) for MDS
Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)
Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)
Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
Phase 2: Overall Survival (OS)
Phase 2: Event-free Survival (EFS)
Phase 2: Transfusion Independence
Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
Phase 2: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
Phase 2: Area Under the Curve (AUClast) for FT-2102
Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102
Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia \[APL\] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site * Good performance status * Good kidney and liver function Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy * Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: FT-2102 (olutasidenib)
- label
- PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
- type
- EXPERIMENTAL
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Azacitidine
- label
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
- type
- EXPERIMENTAL
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Cytarabine
- label
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
- type
- EXPERIMENTAL
- description
- Relapsed or Refractory (R/R) AML
- intervention Names
- Drug: FT-2102 (olutasidenib)
- label
- PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
- type
- EXPERIMENTAL
- description
- AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
- intervention Names
- Drug: FT-2102 (olutasidenib)
- label
- PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
- type
- EXPERIMENTAL
- description
- R/R AML/MDS, previously treated with FT-2102
- intervention Names
- Drug: FT-2102 (olutasidenib)
- label
- PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
- type
- EXPERIMENTAL
- description
- R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Azacitidine
- label
- PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
- type
- EXPERIMENTAL
- description
- R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Azacitidine
- label
- PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
- type
- EXPERIMENTAL
- description
- R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Azacitidine
- label
- PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
- type
- EXPERIMENTAL
- description
- Treatment naïve AML for whom standard treatments are contraindicated
- intervention Names
- Drug: FT-2102 (olutasidenib)
- label
- PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
- type
- EXPERIMENTAL
- description
- Treatment naïve AML who are candidates for azacitidine first line treatment
- intervention Names
- Drug: FT-2102 (olutasidenib)
- Drug: Azacitidine
- label
- PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
- PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent
- PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent
- PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent
- PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent
- PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
- description
- FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
- name
- FT-2102 (olutasidenib)
- type
- DRUG
- arm Group Labels
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine
- PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine
- description
- azacitidine will be administered per site's standard of care
- name
- Azacitidine
- other Names
- Vidaza
- type
- DRUG
- arm Group Labels
- PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine
- description
- low-dose cytarabine will be administered per site's standard of care
- name
- Cytarabine
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 336
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).
- measure
- Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- time Frame
- Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)
- description
- Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death.
- measure
- Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
- time Frame
- Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
- description
- Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate.
- measure
- Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)
- time Frame
- Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)
- description
- Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
- measure
- Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria
- time Frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
- description
- Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L).
- measure
- Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria
- time Frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
- description
- Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%.
- measure
- Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria
- time Frame
- Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)
- description
- RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation.
- measure
- Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate
- time Frame
- Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months)
- secondary Outcomes
- description
- Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented.
- measure
- Phase 1: Area Under the Curve (AUClast) for FT-2102
- time Frame
- Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
- description
- Maximum plasma concentration (Cmax) for FT-2102 is presented.
- measure
- Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102
- time Frame
- Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
- description
- Time to reach the maximum plasma concentration (Tmax) is presented.
- measure
- Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102
- time Frame
- Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)
- description
- TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
- measure
- Phase 1: Time to Response (TTR) for AML
- time Frame
- Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
- description
- Duration of response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
- measure
- Phase 1: Duration of Overall Response for AML
- time Frame
- Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)
- description
- TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
- measure
- Phase 1: Time to Response (TTR ) for MDS
- time Frame
- Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
- description
- TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
- measure
- Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)
- time Frame
- Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
- description
- Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. The estimation of median duration of overall response was done by Kaplan-Meier method.
- measure
- Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)
- time Frame
- Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)
- description
- TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.
- measure
- Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)
- time Frame
- Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)
- description
- Duration of overall response was calculated similarly to DCR but was assessed the time in months between documentation of the first response of PR or better until the date of relapse, death, whichever is earlier. The estimation of median duration of overall response was done by Kaplan-Meier method. The median duration of overall response is defined as the time at which 50% of the participants in a study have experienced the event of interest (relapse or death). Given the presence of only a single participant in the sample, there is an absence of variability in outcomes, and therefore, it was not possible to ascertain a time point at which half of the participants have experienced the event. Hence, median value could not be calculated.
- measure
- Phase 2, Cohort 4 and Cohort 5: Duration of Overall Response for Myelodysplastic Syndrome (MDS)
- time Frame
- Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)
- description
- RFS was calculated for all participants in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all participants in Cohort 2.
- measure
- Phase 2, Cohort 2: Time to Relapse-Free Survival (RFS)
- time Frame
- Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)
- description
- OS is defined as the time in months from the first dose of study drug until death from any cause. For the participants who are not known to have died by the end of study follow-up, OS will be censored on the date the participants was last known to be alive. OS is calculated using Kaplan-Meier method.
- measure
- Phase 2: Overall Survival (OS)
- time Frame
- Phase 2: From first dose of study drug until death from any cause (up to 82 months)
Full study description
- brief Summary
- This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
Source references
- references
- citation
- Cortes J, Curti A, Fenaux P, Jonas BA, Krauter J, Montesinos P, Recher C, Taussig DC, Wang ES, Watts J, Wei A, Yee KW, Tian H, Sheppard A, Marzac C, de Botton S. Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort. J Hematol Oncol. 2025 Nov 14;18(1):102. doi: 10.1186/s13045-025-01751-w.
- pmid
- 41239466
- type
- DERIVED
- citation
- Cortes JE, Yang J, Roboz GJ, Dinner SN, Wang ES, Wei AH, Tian H, di Trapani F, Baer MR, Donnellan W, Watts JM. Olutasidenib alone or combined with azacitidine in patients with mutant IDH1 myelodysplastic syndrome. Blood Adv. 2025 Oct 28;9(20):5293-5305. doi: 10.1182/bloodadvances.2025016718.
- pmid
- 40668616
- type
- DERIVED
- citation
- Cortes JE, Roboz GJ, Baer MR, Jonas BA, Schiller GJ, Yee K, Ferrell PB, Yang J, Wang ES, Blum WG, Mims A, Tian H, Sheppard A, de Botton S, Montesinos P, Curti A, Watts JM; Olutasidenib Combination Therapy Study Group. Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial. J Hematol Oncol. 2025 Jan 16;18(1):7. doi: 10.1186/s13045-024-01657-z.
- pmid
- 39819505
- type
- DERIVED
- citation
- de Botton S, Fenaux P, Yee K, Recher C, Wei AH, Montesinos P, Taussig DC, Pigneux A, Braun T, Curti A, Grove C, Jonas BA, Khwaja A, Legrand O, Peterlin P, Arnan M, Blum W, Cilloni D, Hiwase DK, Jurcic JG, Krauter J, Thomas X, Watts JM, Yang J, Polyanskaya O, Brevard J, Sweeney J, Barrett E, Cortes J. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023 Jul 11;7(13):3117-3127. doi: 10.1182/bloodadvances.2022009411.
- pmid
- 36724515
- type
- DERIVED
- citation
- Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, Pigneux A, Montesinos P, Wang ES, Seiter KP, Wei AH, De Botton S, Arnan M, Donnellan W, Schwarer AP, Recher C, Jonas BA, Ferrell PB Jr, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard SM, Brevard J, Henrick P, Mohamed H, Cortes JE. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2023 Jan;10(1):e46-e58. doi: 10.1016/S2352-3026(22)00292-7. Epub 2022 Nov 10.
- pmid
- 36370742
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- NICAL STUDIES 14.1 Acute Myeloid Leukemia The efficacy of REZLIDHIA was evaluated in an open-label, single-arm, multicenter clinical trial (Study 2102-HEM-101, NCT02719574) in 147 adult patients with relapsed or refractory AML with an IDH1 mutation. IDH1 mutations in blood or bone marrow were confirmed retrospectively using the A
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Preserved source evidence · Not medical advice