WithdrawnPhase 1/2

HDM201 Added to CT in R/R or Newly Diagnosed AML

Stopped: It was determined that the study design may not be optimal given the changing AML treatment landscape.

0Started 2019-11-15

Plain-language summary

This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML. This study is conducted in three parts: dose escalation, dose expansion and DDI study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All Subjects * Signed informed consent must be obtained prior to participation in the study * Age ≥18 * Diagnosis of AML based on WHO 2016 classification. Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that is 0 - 2. * Adequate organ functions * Left ventricular ejection fraction \> 45% For 1L AML population: * For Part 1 or Part 2 Expansion Cohorts 1 or 2: subjects with de novo AML suitable for induction treatment with cytarabine and anthracyclines as per investigator judgement * For Part 2 Expansion Cohort 2: documented presence of FLT3 mutation (ITD or TKD ) and suitable for midostaurin treatment as per investigator judgement. * For Part 2 Expansion Cohort 3: Subjects with secondary AML (e.g. AML-MRC , secondary to myelodysplasia/MDS or therapy-related AML). Prior use of hypomethylating agents or other therapies with curative intent for treatment previous hematological malignancies or therapy-related AML is allowed. Subjects suitable for induction treatment with liposomal cytarabine/daunorubicin as per investigator judgement. For R/R AML population: * All Parts: Diagnosis of relapsed or refractory AML and suitable for treatment with IDAC as per investigator judgement. * For Part 3 only: willingness and suitability to participate in DDI Cohort 1 or 2. Exclusion Criteria: * Prior exposure to MDM2 and MDM4 inhibitor (e.g. idasanutlin) * Known sympt…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1 - Incidence of dose limiting toxicity (DLT)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Time to DLT

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Incidence and severity of Adverse Events (AEs)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 2 - Incidence and severity of AEs/serious adverse events (SAEs)

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Part 2 - Percentage of participants with complete remission (CR)/CR with incomplete recovery (CRi) with adequate blood count recovery (ABCR)

Timeframe: first day of study treatment until 4.5 months after start of study treatment

Part 2 - Incidence and severity of abnormal laboratory values

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Trial details

NCT IDNCT03760445

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-22

View on ClinicalTrials.gov More Leukemia, Myeloid, Acute trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1 - Incidence of dose limiting toxicity (DLT)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Time to DLT

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Incidence and severity of Adverse Events (AEs)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 2 - Incidence and severity of AEs/serious adverse events (SAEs)

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Part 2 - Percentage of participants with complete remission (CR)/CR with incomplete recovery (CRi) with adequate blood count recovery (ABCR)

Timeframe: first day of study treatment until 4.5 months after start of study treatment

Part 2 - Incidence and severity of abnormal laboratory values

Timeframe: first day of study treatment until 8.5 months after start of study treatment