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Cohort A for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Richard Champlin, MD
Research Sponsored by Arog Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission (CR) after allogeneic stem cell transplantation. Oral crenolanib will be administered daily post-transplant for up to two years.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients Who Relapsed
Secondary outcome measures
Transplantation
disease-free survival (DFS)
graft-versus-host disease
+1 more

Side effects data

From 2019 Phase 2 trial • 56 Patients • NCT01657682
85%
Nausea
77%
Diarrhoea
62%
Pneumonia
54%
Fatigue
46%
Oedema peripheral
38%
Febrile neutropenia
38%
Vomiting
38%
Decreased appetite
31%
Hypokalaemia
23%
Hypomagnesaemia
23%
Pleural effusion
15%
Mouth haemorrhage
15%
Dyspnoea
15%
Hypertension
15%
Dysgeusia
15%
Mental status changes
15%
Oropharyngeal pain
15%
Productive cough
15%
Chest pain
15%
Tachycardia
15%
Asthenia
15%
Dyspepsia
15%
Haemorrhoids
15%
Cough
15%
Headache
15%
Tumour lysis syndrome
15%
Pain in extremity
15%
Platelet count decreased
15%
Fluid overload
15%
Hypotension
8%
Abdominal discomfort
8%
Stenotrophomonas sepsis
8%
Vision blurred
8%
Oral pain
8%
Multi-organ failure
8%
Hyponatremia
8%
Pyrexia
8%
Oedema
8%
Deafness
8%
Constipation
8%
Bronchitis
8%
Embolism
8%
Anaemia
8%
Clostridium difficile infection
8%
Pericardial effusion
8%
Wheezing
8%
Mouth hemorrhage
8%
Pancreatitis
8%
Rectal hemorrhage
8%
Death
8%
Cholecystitis
8%
Tumor lysis syndrome
8%
Histiocytosis haematophagic
8%
Ventricular extrasystoles
8%
Respiratory failure
8%
Abdominal pain upper
8%
Gastric haemorrhage
8%
Arthralgia
8%
Lip exfoliation
8%
Septic shock
8%
Urinary tract infection
8%
Cardiac murmur
8%
Metabolic acidosis
8%
Back pain
8%
Acute kidney injury
8%
Epistaxis
8%
Pulmonary embolism
8%
Sinus congestion
8%
Nail discolouration
8%
Petechiae
8%
Rash
8%
Rash macular
8%
Skin irritation
8%
Swelling face
8%
Osteopenia
8%
Gastrointestinal hemorrhage
8%
Chills
8%
Edema peripheral
8%
Abdominal pain
8%
Diplopia
8%
Gastric hemorrhage
8%
Diarrhea
8%
Pain
8%
Hip fracture
8%
Hearing impaired
8%
Proctalgia
8%
Melaena
8%
Gastrointestinal haemorrhage
8%
Contusion
8%
Peripheral swelling
8%
Rectal haemorrhage
8%
Hyperbilirubinaemia
8%
Cellulitis
8%
Fall
8%
Weight increased
8%
Blood creatinine increased
8%
Dystonia
8%
Pruritus
8%
Claustrophobia
8%
Hypermagnesaemia
8%
Blood phosphorus increased
8%
Hyperphosphataemia
8%
White blood cell count increased
8%
Diaphragmalgia
8%
Palmar-plantar erythrodysaesthesia syndrome
8%
Rhinorrhoea
8%
Ingrowing nail
8%
Paraesthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort C - Antecedent Hematological Disorder
Cohort A - No Prior FLT3 TKI Exposure
All Patients
Cohort B - Prior Therapy With FLT3 TKI

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Cohort B will include patients who underwent HSCT with incomplete count recovery although they had ≤%10 bone marrow blasts at the time of HSCT. Crenolanib besylate maintenance therapy will start at the earliest time no sooner than 42 days but no later than 90 days after allogeneic HSCT.
Group II: Cohort AExperimental Treatment1 Intervention
Cohort A will include patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first or second complete remission with count recovery. Crenolanib besylate maintenance therapy will start at the earliest time no sooner than 42 days but no later than 90 days after allogeneic HSCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crenolanib besylate
2012
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Arog Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
1,296 Total Patients Enrolled
Richard Champlin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
2015. "Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02400255.
~3 spots leftby Apr 2025
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