Skip to main content
OpenTrials
Completed

NCT Number: NCT02400281

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

For each arm:

The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design.

Phase II total of 52 patients (26 per arm) will be treated at established phase I dose.

Enrollment to be simultaneous to each arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of refractory/relapsed AML or high-risk MDS
  • Arm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapies
  • Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
  • FLT3 mutation positive (ITD, TKD or other)
  • ECOG PS 0-2
  • Adequate liver and renal function
  • Negative pregnancy test
  • Extramedullary leukemia allowed except CNS disease

Exclusion criteria

  • Arm 1 and 2 Exclusion:
  • <5% blasts in marrow or blood at time of screening
  • Active HIV, hepatitis B or C
  • CNS leukemia
  • Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
  • Patient with AML-M3 (APL)
  • Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)

Treatment and study plan

Crenolanib besylate

Drug

Other names: CP-868,596-26

Idarubicin

Drug

Other names: 4-demethoxydaunorubicin

Cytarabine

Drug

Other names: cytosine arabinoside

Azacytidine

Drug

Other names: 5-azacytidine

Mitoxantrone

Drug

Other names: Novantrone

etoposide

Drug

Other names: etoposide phosphate

Fludarabine

Drug

Other names: Fludarabine phosphate

G-CSF

Drug

Primary outcomes

  1. Response Rate of Crenolanib Besylate Combination Therapy

    Time frame: Baseline up to first documented response, persistent disease, or death (whichever occurs first), 1 year.

    To determine the response rate to crenolanib. CR Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not experience either platelet recovery or ANC recovery. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or MLFS. Death in aplasia response include deaths occurring following chemotherapy while cytopenic with an aplastic or hypoplastic BM prior to death without evidence of persistent leukemia.

Sponsors and collaborators

Lead sponsor

Arog Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2015
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.