Status:
WITHDRAWN
A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Conditions:
Relapsed/Refractory FLT3-mutated AML
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
This is a phase II, multicenter, single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsed/refracto...
Eligibility Criteria
Inclusion
- Age ≥ 1 years and ≤ 21 years
- Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
- Definitive evidence of a FLT3-ITD and/or FLT3-TKD (D835/I836) mutation at the time of enrollment
- Patients must have histologically or molecularly confirmed relapsed or refractory AML
- Karnofsky or Lansky performance score ≥ 50. Use Karnofsky for patients \> 16 years old and Lansky for patients ≤ 16 years of age.
- Adequate renal function, defined as:
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or
- Normal serum creatinine based on age/gender
- Adequate liver function, defined as:
- Serum total bilirubin ≤ 1.5x ULN for age,
- Serum aspartate aminotransferase (AST) ≤ 3.0x ULN for age, and
- Serum alanine aminotransferase (ALT) ≤ 3.0x ULN for age.
Exclusion
- Patients with any of the following current or previous diagnoses:
- Acute promyelocytic leukemia (APL)
- Down syndrome
- DNA fragility or bone marrow failure syndromes (such as Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Shwachman syndrome)
- AML secondary to prior MDS/MPN, including chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia
- Blastic plasmacytoid dendritic cell neoplasm
- Acute leukemia of ambiguous lineage
- B-lymphoblastic leukemia/lymphoma
- T-lymphoblastic leukemia/lymphoma, including early T-cell precursor lymphoblastic leukemia (ETP-ALL)
- Patients who are refractory to first line (induction and re-induction) and a second line (1st salvage) treatment for AML.
- Patients who have received more than 1 prior allogeneic HSCT
- Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection of which they exhibit ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
- Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
- Known severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia)
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Currently receiving prophylactic treatment of hepatitis B with anti-viral therapy
- Known infection with human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03324243
Start Date
January 1 2018
End Date
December 1 2020
Last Update
January 10 2019
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