NCT04522895 is a Phase 2 clinical trial of Enasidenib in Leukemia, Myeloid, Acute, sponsored by Heinrich-Heine University, Duesseldorf.

Who is sponsoring NCT04522895?

NCT04522895 is sponsored by Heinrich-Heine University, Duesseldorf.

What drugs are being tested in NCT04522895?

Interventions in NCT04522895: Enasidenib.

What condition does NCT04522895 study?

NCT04522895 studies Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, IDH2 R172, IDH2 R140.

Is NCT04522895 still recruiting?

NCT04522895 is currently completed. Last updated 19 September 2024.

Last reviewed 2024-09-19 · How we verify

NCT04522895

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

IDH2-Post-Allo-Trial for Patients with IDH2-mut Myeloid Neoplasms After Allo-SCT

Completed Phase 2 Last updated 19 September 2024

What this trial tests

Phase 2 trial testing Enasidenib in Leukemia, Myeloid, Acute in 50 participants. Completed in 24 July 2024.

Timeline

27 August 2020

Primary endpoint
24 July 2024

24 July 2024

Quick facts

Lead sponsor	Heinrich-Heine University, Duesseldorf
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	27 August 2020
Primary completion	24 July 2024
Estimated completion	24 July 2024
Sites	11 locations across Germany

Drugs / interventions tested

Enasidenib (ENASIDENIB) — full drug profile →

Conditions studied

Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →
Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
IDH2 Gene Mutation — all drugs for IDH2 Gene Mutation →

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, any sex, with Leukemia, Myeloid, Acute or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open label, single arm, multi-centre phase II trial aiming to evaluate the safety and efficacy of Enasidenib (investigational product) as prophylactic consolidation in patients with IDH2-mutated MDS, CMML and AML in remission after allo-SCT.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6
New drugs before, during, and after hematopoietic stem cell transplantation for patients with acute myeloid leukemia.
Mohty R, El Hamed R, Brissot E, Bazarbachi A, et al · · 2023 · cited 28× · PMID 36722403 · DOI 10.3324/haematol.2022.280798
Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation.
Kunadt D, Stasik S, Metzeler KH, Röllig C, et al · · 2022 · cited 20× · PMID 36064577 · DOI 10.1186/s13045-022-01339-8
Current Status and Perspectives of Allogeneic Hematopoietic Stem Cell Transplantation in Elderly Patients with Acute Myeloid Leukemia.
Sophie S, Yves B, Frédéric B. · · 2022 · cited 15× · PMID 35438781 · DOI 10.1093/stcltm/szac015
New Perspectives in Treating Acute Myeloid Leukemia: Driving towards a Patient-Tailored Strategy.
Andreozzi F, Massaro F, Wittnebel S, Spilleboudt C, et al · · 2022 · cited 15× · PMID 35409248 · DOI 10.3390/ijms23073887
How I reduce and treat posttransplant relapse of MDS.
Mina A, Greenberg PL, Deeg HJ. · · 2024 · cited 12× · PMID 38306658 · DOI 10.1182/blood.2023023005

Verify or expand the search:

Other trials of Enasidenib

Trials testing the same drug.

NCT06577441 — Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myel · Phase 2 · recruiting
NCT06672146 — Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMAT · Phase 2 · recruiting
NCT06240754 — Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial · Phase 2 · recruiting
NCT05564390 — MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Wi · Phase 2 · recruiting
NCT06176989 — Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors · Phase 2 · recruiting

Other recruiting trials for Leukemia, Myeloid, Acute

Currently open trials in the same condition.

NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting

Other Heinrich-Heine University, Duesseldorf trials

Trials by the same sponsor.

NCT04993508 — Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Co · NA · not yet recruiting
NCT07385482 — Chronic and Acute Cardiovascular Diseases in Elderly Intensive Care Patients · not yet recruiting
NCT07455097 — COMBINED PSMA-PET/CT AND MRI STAGING IN INTERMEDIATE AND HIGH-RISK PATIENTS PROSTATA-CANCER (COMBINE-P) · active not recruiting
NCT07254663 — GEL & MEDication Dysphagia · recruiting
NCT06313944 — German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04522895 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Heinrich-Heine University, Duesseldorf
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04522895.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing