Phase 2
N=13
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations
Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Bottom Line
View on ClinicalTrials.gov: NCT01522469 ↗Enrolled (actual)
13
Serious AEs
92.3%
Results posted
Jan 2024
Primary outcome: Primary: Overall Response Rate — 5; 2; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Crenolanib Besylate (CP-868,596-26) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arog Pharmaceuticals, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
5; 2; 3; 1; 1; 0 | — |
Summary
This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight hours), taken orally at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
Eligibility Criteria
Inclusion Criteria
- Relapsed/refractory primary AML or AML secondary to antecedent hematologic disorder with an expected survival of 3 months or greater
- Patients must have tested positive for FLT3-ITD and /or other FLT3 activating mutations within /=Grade 2 persistent non hematological toxicity related to the transplant or did not receive crenolanib prior to HSCT
- Evidence of lack of engraftment if post allogeneic transplant
- Unable to swallow pills
- Major surgical procedures within 14 days of Cycle 1 Day 1 administration of crenolanib
- Unwillingness or inability to comply with protocol.
Data sourced from ClinicalTrials.gov (NCT01522469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.