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NCT02400281 · ClinicalTrials.gov registry record · Phase 1
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Arog Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT02400281: Completed Phase 1 study of Acute Myeloid Leukemia, sponsored by Arog Pharmaceuticals.
NCT02400281 is a Phase 1 study of Acute Myeloid Leukemia that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 28 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02400281, a Phase 1 study of Acute Myeloid Leukemia, has completed, sponsored by Arog Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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 d
Conditions Studied
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Mitoxantrone
- DRUG Azacytidine
- DRUG Crenolanib besylate
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 1 |
What the finished NCT02400281 record still lists
NCT02400281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cytarabine is the first listed.
NCT02400281 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02400281 about?
NCT02400281 is a clinical study titled "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
What is the current status of trial NCT02400281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-09. Estimated completion is 2020-07-15.
What conditions does trial NCT02400281 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT02400281?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Mitoxantrone (DRUG), Azacytidine (DRUG), Crenolanib besylate (DRUG).
Who is sponsoring clinical trial NCT02400281?
This trial is sponsored by Arog Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02400281 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02400281's enrollment target sits among peer trials
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