# Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

> **NCT03813147** · PHASE1 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 12 (actual)

## Conditions studied

- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Recurrent Acute Myeloid Leukemia
- Recurrent Myelodysplastic Syndrome
- Refractory Acute Myeloid Leukemia
- Refractory Myelodysplastic Syndrome

## Interventions

- **DRUG:** Azacitidine
- **DRUG:** Cytarabine
- **DRUG:** Fludarabine Phosphate
- **DRUG:** Methotrexate
- **DRUG:** Pevonedistat
- **DRUG:** Therapeutic Hydrocortisone

## Key facts

- **NCT ID:** NCT03813147
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-05-17
- **Primary completion:** 2021-09-30
- **Final completion:** 2023-12-31
- **Target enrollment:** 12 (ACTUAL)
- **Last updated:** 2025-04-13

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03813147

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03813147, "Pevonedistat, Azacitidine, Fludarabine Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome". Retrieved via AI Analytics 2026-07-04 from https://api.ai-analytics.org/clinical/NCT03813147. Licensed CC0.

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