Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML

Phase 1

Completed

• Conditions: Relapsed/Refractory Acute Myeloid Leukemia (AML)
• Interventions: Drug: Crenolanib; Drug: Mitoxantrone; Drug: Cytarabine; Drug: Fludarabine; Drug: Etoposide; Drug: G-CSF; Drug: Idarubicin

• Registration Number: NCT02626338
• Lead Sponsor: Arog Pharmaceuticals, Inc.

Brief Summary

The proposed study is designed to combine crenolanib with standard salvage chemotherapy to treat patients with R/R AML irrespective the FLT3 status.

Detailed Description

Open label, dose de-escalation, pilot trial of crenolanib with standard salvage chemotherapy. Subjects may receive up to 2 cycles of induction with standard salvage chemotherapy followed by crenolanib. Each arm will enroll approximately 24 patients (72 total); stratification to each arm will be per physician's choice

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-10
• Study Start: 2016-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Disposition First Submitted: 2019-05-06
• Disposition First Submitted QC: 2019-05-08
• Disposition First Posted: 2019-05-14
• Results First Submitted: 2021-04-28
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Results First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Idarubicin	* Fludarabine * Cytarabine * G-CSF * Idarubicin * Crenolanib
Arm C	Etoposide	* Mitoxantrone * Etoposide * Cytarabine * Crenolanib
Arm A	Crenolanib	* Mitoxantrone * Cytarabine * Crenolanib
Arm A	Cytarabine	* Mitoxantrone * Cytarabine * Crenolanib
Arm B	Crenolanib	* Fludarabine * Cytarabine * G-CSF * Idarubicin * Crenolanib
Arm A	Mitoxantrone	* Mitoxantrone * Cytarabine * Crenolanib
Arm B	Cytarabine	* Fludarabine * Cytarabine * G-CSF * Idarubicin * Crenolanib
Arm B	Fludarabine	* Fludarabine * Cytarabine * G-CSF * Idarubicin * Crenolanib
Arm B	G-CSF	* Fludarabine * Cytarabine * G-CSF * Idarubicin * Crenolanib
Arm C	Crenolanib	* Mitoxantrone * Etoposide * Cytarabine * Crenolanib
Arm C	Mitoxantrone	* Mitoxantrone * Etoposide * Cytarabine * Crenolanib
Arm C	Cytarabine	* Mitoxantrone * Etoposide * Cytarabine * Crenolanib

Primary Outcome Measures

Name	Time	Method
Clinical Response to Crenolanib With Standard Salvage Chemotherapy	1 year	To determine the response rate to crenolanib. 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 have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but \>5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy.

Trial Locations

Locations (4)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States