Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Daunorubicin

Idarubicin

Crenolanib

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients will be given cytarabine and daunorubicin during induction therapy plus crenolanib at 100 mg TID.

Patients will be given cytarabine and idarubicin during induction therapy plus crenolanib at 100 mg TID.

crenolanib

cytarabine

daunorubicin

idarubicin

Richard Stone, MD

This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.

A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

A Safety and Tolerability Trial of Crenolanib and Chemotherapy With Cytarabine and Anthracyclines in Patients With Newly Diagnosed Acute Myeloid Leukemia With FLT3 Activating Mutations

To determine the response rate to crenolanib. Complete remission (CR) response criteria includes a post-baseline bone marrow (BM) biopsy or aspiration % blasts \<5%, the absence of Auer rods and extramedullary leukemia, absolute neutrophil count (ANC) \>1×10\^9/L and platelet count \>100×10\^9/L. Complete remission with incomplete blood count recovery (CRi) response includes all CR criteria met, except participant do not achieve either platelet or ANC recovery. Composite Complete CR response includes all subjects who achieve a CR and CRi. Partial Response (PR) response includes all CR criteria met except a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but within 5-25% or bone marrow blasts \<5% with persistent Auer rods. Refractory Disease response includes subjects who do not satisfy the criteria for CR, CRi or PR.

Overall survival (OS) was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive. OS at 3-years is presented.

Arog Pharmaceuticals, Inc.

Participants ≤60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.

Participants Less Than or Equal to 60 Years of Age

Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.

Participants Greater Than 60 Years of Age

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Asian

Black or African American

American Indian or Alaska Native

Other

Race/Ethnicity, Customized

ITD only

TKD only

ITD and TKD

Mutations in the gene encoding the trans-membrane tyrosine kinase FLT3. The type of FLT3 mutation detected by bone marrow assessment at diagnosis was collected. Subjects had either internal tandem duplications (ITD) in the juxtamembrane domain, point mutations or deletions in the tyrosine kinase domain (TKD) or both ITD and TKD mutations together.

FLT3 Mutations

Normal

Abnormal, not complex

Complex

Not Available

Cytogenetics is the study of the structure and properties of chromosomes. Cytogenetics data was provided by local labs through karyotyping and fluorescent in situ hybridization (FISH). Participants either had normal cytogenetics, abnormal cytogenetics that did not fulfil the definition of complex and abnormal complex cytogenetics. Abnormal cytogenetics represents an irregularity in the number or structure of chromosomes. Complex cytogenetics is defined as the presences of more than or equal to 3 independent abnormalities. Cytogenetics data was not available for 1 participant.

Cytogenetics

Whether or not subjects had a prior history of antecedent hematological disease. Subjects with de novo AML do not have a history of antecedent hematological disease, while subjects with secondary AML do.

AML with Antecedent Hematological Disorders

Edward McDonald

Composite Complete Remission (CR + CRi)

Complete Remission (CR)

Complete Remission with incomplete count recovery (CRi)

Partial Remission (PR)

Refractory Disease

Not evaluable

Participants who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transplant received 12 cycles of crenolanib post-transplant.

All Patients

Clinical Response to Crenolanib With Standard Induction Chemotherapy

3-Year Overall Survival

Participants \>60yrs old who had AML with FLT3 activating mutations received 7+3 induction therapy with cytarabine and either daunorubicin or idarubicin followed by 100 mg crenolanib besylate administered orally three times a day. The participants then received up to four cycles of consolidation chemotherapy with high dose cytarabine followed by 100 mg crenolanib besylate three times a day. Participants not undergoing hematopoietic stem cell transplant received crenolanib for an additional 12 cycles and participants undergoing transpolant received 12 cycles of crenolanib post-transplant.

Overall Study

Spots Global Cancer Trial Database for A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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