Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Acute Myeloid Leukemia Clinical Trial

Official title:
Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Status Terminated

Clinical Trial Summary

The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion /exclusion criteria. An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine (MC) in 18 patients according to the experimental arm of the study. After completion of this dose-finding run-in phase I, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded, placebo-controlled, randomized phase of the study. The double-blinded, placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee. Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant. Sample size randomized phase: 276 patients Primary objective: To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating mutations.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02298166
Study type	Interventional
Source	University of Ulm
Contact
Status	Terminated
Phase	Phase 3
Start date	November 17, 2016
Completion date	March 9, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04460235` - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	Phase 4
Completed	`NCT03678493` - A Study of FMT in Patients With AML Allo HSCT in Recipients	Phase 2
Completed	`NCT04022785` - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT05424562` - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Terminated	`NCT03224819` - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)	Early Phase 1
Completed	`NCT03197714` - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia	Phase 1
Active, not recruiting	`NCT04070768` - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Active, not recruiting	`NCT04107727` - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)	Phase 2
Recruiting	`NCT04920500` - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients	N/A
Recruiting	`NCT04385290` - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)	Phase 1/Phase 2
Recruiting	`NCT03897127` - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics	Phase 3
Active, not recruiting	`NCT04021368` - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT03665480` - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML	Phase 2/Phase 3
Completed	`NCT02485535` - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant	Phase 1
Enrolling by invitation	`NCT04093570` - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers	Phase 2
Recruiting	`NCT04069208` - IA14 Induction in Young Acute Myeloid Leukemia	Phase 2
Recruiting	`NCT05744739` - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)	Phase 1
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2