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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Crenolanib besylate
Idarubicin
Cytarabine
Azacytidine
Mitoxantrone
Etoposide
Fludarabine
G-CSF
Sponsored by
Arog Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. FLT3 mutation positive (ITD, TKD or other)
  3. ECOG PS 0-2
  4. Adequate liver and renal function
  5. Negative pregnancy test
  6. Extramedullary leukemia allowed except CNS disease

Exclusion Criteria:

  • Arm 1 and 2 Exclusion:

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

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1 crenolanib besylate combination

Arm 2 crenolanib besylate combination

Arm Description

Arm 1 patients will receive crenolanib besylate, combined with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin

Arm 2 patients will receive crenolanib besylate and azacytidine.

Outcomes

Primary Outcome Measures

Dose-limiting toxicities of crenolanib besylate combination therapy
Response rate of crenolanib besylate combination therapy

Secondary Outcome Measures

Duration of response
Progression free survival
Overall survival

Full Information

First Posted
March 18, 2015
Last Updated
July 17, 2020
Sponsor
Arog Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02400281
Brief Title
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arog Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 crenolanib besylate combination
Arm Type
Experimental
Arm Description
Arm 1 patients will receive crenolanib besylate, combined with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin
Arm Title
Arm 2 crenolanib besylate combination
Arm Type
Experimental
Arm Description
Arm 2 patients will receive crenolanib besylate and azacytidine.
Intervention Type
Drug
Intervention Name(s)
Crenolanib besylate
Other Intervention Name(s)
CP-868,596-26
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Other Intervention Name(s)
4-demethoxydaunorubicin
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
cytosine arabinoside
Intervention Type
Drug
Intervention Name(s)
Azacytidine
Other Intervention Name(s)
5-azacytidine
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Other Intervention Name(s)
Novantrone
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
etoposide phosphate
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
G-CSF
Primary Outcome Measure Information:
Title
Dose-limiting toxicities of crenolanib besylate combination therapy
Time Frame
6 months
Title
Response rate of crenolanib besylate combination therapy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
2 years
Title
Progression free survival
Time Frame
2 years
Title
Overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cortes, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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