# A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

> **NCT03850535** · PHASE1,PHASE2 · TERMINATED · sponsor: **Hoffmann-La Roche** · enrollment: 24 (actual)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **DRUG:** Idasanutlin
- **DRUG:** Cytarabine
- **DRUG:** Daunorubicin
- **PROCEDURE:** Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

## Key facts

- **NCT ID:** NCT03850535
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2019-03-25
- **Primary completion:** 2020-09-10
- **Final completion:** 2020-09-10
- **Target enrollment:** 24 (ACTUAL)
- **Why stopped:** Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.
- **Last updated:** 2022-06-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03850535

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03850535, "A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT03850535. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*