Study of Low-Dose Cytarabine & Etoposide With or Without All-Trans

Clinical Trial Summary

This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy.

Sample size: 144 patients

Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial)

Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)

See also
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Terminated	`NCT02927938` - Leukemia Stem Cell Detection in Acute Myeloid Leukemia	Phase 3
Completed	`NCT01772953` - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT	Phase 2
Recruiting	`NCT03188874` - Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Completed	`NCT00071006` - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)	Phase 2
Completed	`NCT04079296` - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)	Phase 1/Phase 2
Completed	`NCT04509622` - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)	Phase 3
Withdrawn	`NCT03699384` - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)	Phase 1/Phase 2
Recruiting	`NCT03613532` - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN	Phase 1
Terminated	`NCT02259348` - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation	Phase 2
Completed	`NCT02252107` - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1	Phase 2
Terminated	`NCT01463410` - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler	N/A
Completed	`NCT01242774` - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)	Phase 1
Terminated	`NCT02134782` - Yoga Fatigue Study	N/A
Completed	`NCT01685619` - AML-MDS Novel Prognostic Tests Clinical Study
Completed	`NCT03625505` - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia	Phase 1
Active, not recruiting	`NCT04266795` - A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy	Phase 2

NCT number	NCT01237808
Study type	Interventional
Source	University of Ulm
Contact
Status	Completed
Phase	Phase 3
Start date	March 2011
Completion date	July 13, 2018

Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms