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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03839771




Registration number
NCT03839771
Ethics application status
Date submitted
6/02/2019
Date registered
15/02/2019

Titles & IDs
Public title
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
Scientific title
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled 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 Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.
Secondary ID [1] 0 0
2018-000451-41
Secondary ID [2] 0 0
HO150
Universal Trial Number (UTN)
Trial acronym
HOVON150AML
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Myelodysplastic Syndrome With Excess Blasts-2 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Blood 0 0 0 0
Anaemia
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AG-120
Treatment: Drugs - Placebo for AG-120
Treatment: Drugs - AG-221
Treatment: Drugs - Placebo for AG-221

Placebo comparator: Arm A: Placebo - Cycle 1: day 1-start cycle 2 \| Cycle 2: day 1 - start consolidation treatment \| Consolidation treatment: day 1 - start maintenance \| Maintenance treatment: day 1- day 730 (2 years) \|

The dosage for Placebo for AG-120 (IDH1): 500 mg dose/day

The dosage for Placebo for AG-221 (IDH2): 100mg dose/day

Experimental: Arm B: Ivosidenib (IDH1) or Enasidenib (IDH2) - Cycle 1: day 1-start cycle 2 \| Cycle 2: day 1 - start consolidation treatment \| Consolidation treatment: day 1 - start maintenance \| Maintenance treatment: day 1- day 730 (2 years) \|

The dosage for AG-120 (IDH1): 500 mg dose/day

The dosage for AG-221 (IDH2): 100mg dose/day


Treatment: Drugs: AG-120
250mg tablets

Treatment: Drugs: Placebo for AG-120
250mg tablets

Treatment: Drugs: AG-221
100mg tablets

Treatment: Drugs: Placebo for AG-221
100mg tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival (EFS)
Timepoint [1] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Approximately up to 84 months following first patient enrollment
Secondary outcome [2] 0 0
Relapse-free survival (RFS) after CR/CRi
Timepoint [2] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [3] 0 0
Cumulative incidence of relapse (CIR) after CR/CRi
Timepoint [3] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [4] 0 0
Cumulative incidence of death (CID) after CR/CRi
Timepoint [4] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [5] 0 0
Complete remission without minimal residual disease (CRMRD-) rate after induction cycle 2
Timepoint [5] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [6] 0 0
Frequency and severity of adverse events according to CTCAE version 5.0
Timepoint [6] 0 0
Continuously throughout the study, starting from informed consent until 30 days following the last administration of any study drug
Secondary outcome [7] 0 0
CR/CRi rates after induction cycle 1 and 2
Timepoint [7] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [8] 0 0
CR/CRi rate after remission induction (i.e., CR or CRi as best response during or at completion of induction therapy)
Timepoint [8] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [9] 0 0
Time to hematopoietic recovery after each chemotherapy treatment cycle
Timepoint [9] 0 0
Approximately up to 60 months following first patient enrollment
Secondary outcome [10] 0 0
EQ-5D-5L visual analogue scale (VAS)
Timepoint [10] 0 0
At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)
Secondary outcome [11] 0 0
EORTC-QLQ-C30 global health status/QoL scale.
Timepoint [11] 0 0
At entry, 1st day of maintenance, every 3 months during the first year of maintenance, every 6 months during the second year of maintenance until relapse or treatment discontinuation (approximately up to 84 months following first patient enrollment)

Eligibility
Key inclusion criteria
* Age =18 years
* Newly diagnosed AML or MDS-EB2 defined according to WHO criteria, with a documented IDH1 or IDH2 gene mutation (as determined by the clinical trial assay) at a specific site (IDH1 R132, IDH2 R140, IDH2 R172). AML may be secondary to prior hematological disorders, including MDS, and/or therapy-related (in which prior disease should have been documented to have existed for at least 3 months). Patients may have had previous treatment with hypomethylating agents (HMAs) for MDS. HMAs have to be stopped at least four weeks before registration
* Patients with dual mutant FLT3 and IDH1 or IDH2 mutations may be enrolled only if, for medical or other reasons, treatment with a FLT3 inhibitor is not considered.
* Considered to be eligible for intensive chemotherapy.
* ECOG/WHO performance status = 2
* Adequate hepatic function as evidenced by:

* Serum total bilirubin = 2.5 × upper limit of normal (ULN) unless considered due to Gilbert's disease (e.g. a mutation in UGT1A1) (only for patients in IDH2 cohort), or leukemic involvement of the liver - following written approval by the (Co)Principal Investigator.
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 3.0 × ULN, unless considered due to leukemic involvement of the liver, following written approval by the Principal Investigator.
* Adequate renal function as evidenced by creatinine clearance > 40 mL/min based on the Cockroft-Gault formula for glomerular filtration rate (GFR).
* Able to understand and willing to sign an informed consent form (ICF).
* Written informed consent

Female patient must either:

o Be of nonchildbearing potential: Postmenopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)

o Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 6 months after the final study drug administration And have a negative urine or serum pregnancy test at screening And, if heterosexually active, agree to consistently use highly effective* contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 6 months after the final study drug administration.

* Highly effective forms of birth control include:

* Consistent and correct usage of established hormonal contraceptives that inhibit ovulation,
* Established intrauterine device (IUD) or intrauterine system (IUS),
* Bilateral tubal occlusion,
* Vasectomy (A vasectomy is a highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.)
* Male is sterile due to a bilateral orchiectomy.
* Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
* List is not all inclusive. Prior to enrollment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control per the requirements of the CTFG Guidance document 'Recommendations related to contraception and pregnancy testing in clinical trials', September 2014 (and any updates thereof) during the protocol defined period.

* Female patient must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration.
* Female patient must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.

* Male patient and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration
* Male patient must not donate sperm starting at screening and throughout the study period and for 4 months and 1 week after the final study drug administration.

* Subject agrees not to participate in another interventional study while on treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior chemotherapy for AML or MDS-EB2 (with the exception of HMA). Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts > 30x109/L).
* Dual IDH1 and IDH2 mutations.
* Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations.
* Blast crisis after chronic myeloid leukemia (CML).
* Known allergy or suspected hypersensitivity to Ivosidenib or Enasidenib and/or any exipients.
* Taking medications with narrow therapeutic windows with potential interaction with investigational medication (see Appendix I), unless the patient can be transferred to other medications prior to enrolling or unless the medications can be properly monitored during the study.
* Taking P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) transporter-sensitive substrate medications (see Appendix J) unless the patient can be transferred to other medications within = 5 half-lives prior to administration of ivosidenib or enasidenib, or unless the medications can be properly monitored during the study.
* Breast feeding at the start of study treatment.
* Active infection, including hepatitis B or C or HIV infection that is uncontrolled at randomization. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed.
* Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed:

* Basal or squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Carcinoma in situ of the breast
* Incidental histologic finding of prostate cancer
* Significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure (appendix G); myocardial infarction, unstable angina and/or stroke; or left ventricular ejection fraction (LVEF) < 40% by ultrasound or MUGA scan obtained within 28 days prior to the start of study treatment.
* QTc interval using Fridericia's formula (QTcF) = 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure,family history of long QT interval syndrome). Prolonged QTc interval associated with bundle branch block or pacemaking is permitted with written approval of the Principal Investigator.
* Taking medications that are known to prolong the QT interval (see Appendix K), unless deemed critical and without a suitable alternative. In those cases, they may be administered, but with proper monitoring (see section 10.2, Table 13).
* Dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.
* Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.
* A known medical history of progressive multifocal leukoencephalopathy (PML).
* Immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or severe disseminated intravascular coagulation
* Any other medical condition deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or participate in the study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2034
Actual
Sample size
Target
968
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU-Adelaide-FLINDERS - Adelaide
Recruitment hospital [2] 0 0
AU-Adelaide-RAH - Adelaide
Recruitment hospital [3] 0 0
AU-Brisbane-PAH - Brisbane
Recruitment hospital [4] 0 0
AU-Camperdown-RPA - Camperdown
Recruitment hospital [5] 0 0
AU-Canberra-CANBERRAHOSPITAL - Canberra
Recruitment hospital [6] 0 0
AU-Douglas-TOWNSVILLE - Douglas
Recruitment hospital [7] 0 0
AU-Hobart TAS-RHOBART - Hobart
Recruitment hospital [8] 0 0
AU-Launceston TAS-LAUNCESTON - Launceston
Recruitment hospital [9] 0 0
AU-Melbourne-ALFRED - Melbourne
Recruitment hospital [10] 0 0
AU-Melbourne-AUSTIN - Melbourne
Recruitment hospital [11] 0 0
AU-Melbourne-MONASH - Melbourne
Recruitment hospital [12] 0 0
AU-Melbourne-RMELBOURNE - Melbourne
Recruitment hospital [13] 0 0
AU-Melbourne-SVHM - Melbourne
Recruitment hospital [14] 0 0
AU-Perth-FSH - Perth
Recruitment hospital [15] 0 0
AU-Perth-RPH - Perth
Recruitment hospital [16] 0 0
AU-Perth-SCGH - Perth
Recruitment hospital [17] 0 0
AU-Sydney-CONCORD - Sydney
Recruitment hospital [18] 0 0
AU-Sydney-RNSH - Sydney
Recruitment hospital [19] 0 0
AU-Sydney-SVHS - Sydney
Recruitment hospital [20] 0 0
AU-Sydney-WSAH - Sydney
Recruitment hospital [21] 0 0
AU-Waratah-CALVARYMATER - Waratah
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Canberra
Recruitment postcode(s) [5] 0 0
- Douglas
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Launceston
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment postcode(s) [10] 0 0
- Sydney
Recruitment postcode(s) [11] 0 0
- Waratah
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
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Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
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Linz
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Austria
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Vienna
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Haine-Saint-Paul
Country [10] 0 0
Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Roeselare
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Belgium
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Yvoir
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Estonia
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Tartu
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Finland
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Helsinki
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Finland
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Tampere
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France
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Amiens
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Angers
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Argenteuil
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Bayonne
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Besançon
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Bobigny
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Chambéry
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Chesnay
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Clamart
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Créteil
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Grenoble cedex 9
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Lens
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Lille
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Limoges
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Lyon
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Marseille
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Montpellier
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Mulhouse
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Nantes
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Nice
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Orléans
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Paris
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Pessac
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Poitiers
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Reims
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Rennes
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Rouen
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Strasbourg
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Toulouse
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Tours
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Vandœuvre-lès-Nancy
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Villejuif
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Bad Saarow
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Berlin
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Bochum
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Bonn
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Braunschweig
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Bremen
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Dortmund
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Düsseldorf
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Essen
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Esslingen
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Flensburg
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Gießen
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Goch
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Hamburg
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Hamm
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Hanau
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Hannover
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Herne
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Homburg
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Karlsruhe
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Lebach
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Lemgo
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Ludwigshafen
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Lüdenscheid
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Magdeburg
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Mainz
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Meschede
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Germany
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Minden
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München
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Offenburg
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Oldenburg
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Passau
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Stuttgart
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Traunstein
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Trier
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Tübingen
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Ulm
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Villingen-Schwenningen
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Wuppertal
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Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Galway
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Lithuania
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Vilnius
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Netherlands
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Amersfoort
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Amsterdam
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Arnhem
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Breda
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Delft
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Den Haag
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Dordrecht
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Eindhoven
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Enschede
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Groningen
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Leeuwarden
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Leiden
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Maastricht
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Nieuwegein
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Nijmegen
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Rotterdam
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Utrecht
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Zwolle
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromsø
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Norway
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Trondheim
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Spain
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Barcelona
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Girona
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Madrid
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Spain
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Palma
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Spain
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Tarragona
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Spain
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Valencia
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Uppsala
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Switzerland
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Basel
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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Fribourg
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Switzerland
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Geneve
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Lausanne
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Luzern
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Saint Gallen
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Switzerland
State/province [136] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
Stichting Hemato-Oncologie voor Volwassenen Nederland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
B.J. Wouters
Address 0 0
Erasmus MC / HOVON
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
B.J. Wouters, Dr.
Address 0 0
Country 0 0
Phone 0 0
+31 10 704 15 60
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03839771