# Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML

> **NCT03504410** · PHASE3 · TERMINATED · sponsor: **Cornerstone Pharmaceuticals** · enrollment: 200 (actual)

## Conditions studied

- Relapsed/Refractory Acute Myeloid Leukemia

## Interventions

- **DRUG:** CPI-613 + High Dose Cytarabine and Mitoxantrone
- **DRUG:** High Dose Cytarabine and Mitoxantrone
- **DRUG:** Mitoxantrone, Etoposide and Cytarabine
- **DRUG:** Fludarabine, Cytarabine, Filgrastim

## Key facts

- **NCT ID:** NCT03504410
- **Lead sponsor:** Cornerstone Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-11-12
- **Primary completion:** 2021-10-25
- **Final completion:** 2022-01-19
- **Target enrollment:** 200 (ACTUAL)
- **Why stopped:** Futile
- **Last updated:** 2023-02-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03504410

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03504410, "Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT03504410. Licensed CC0.

---

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