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

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Other Dietary Supplements

Benzocaine

Crenolanib

Tannic Acid

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.

Crenolanib Besylate (CP-868,596-26)

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.

Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations

A Phase II Study of Crenolanib Besylate in Subjects With Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

To determine the response rate to crenolanib.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. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but \>5%. Hematologic improvement (HI) response included erythroid response where Hgb increased ≥ 1.5 g/dL, platelet response where platelets increased ≥ 30 x 10\^9/L for patient starting with \>20 x 10\^9/L platelets or increase from \<20 x 10\^9/L to \>20 x 10\^9/L and by at least 100% and neutrophil response where at least 100% increase and an increase \>0.5 x 10\^9/L. Resistant Disease (RD) was defined as the absence of CR, CRi, CRp, PR or HI.

Arog Pharmaceuticals, Inc.

Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their prior TKI exposure and their response to crenolanib therapy.

Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses 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 were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.

All Patients

Participants who had relapsed/refractory AML with FLT3 activating mutations whose leukemia progressed and have a history of prior therapy with one or more FLT3 TKIs received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses 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 were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.

TKI Pre-treated

Participants who had relapsed/refractory AML with FLT3 activating mutations who progressed on one or more prior chemotherapy regimens excluding any FLT3 TKI received either 200mg/m2 /day crenolanib divided in three doses daily or 100mg TID depending on the version of the protocol at the time of their enrolment. (preferably every eight hours), taken orally at least 30 minutes pre or post meal. Crenolanib was taken orally at the abovementioned doses 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 were able to proceed to allogeneic stem cell transplant were able to resume crenolanib therapy post-transplant in an attempt to maintain remission.

TKI Naive

Total

18 to 44 years

45 to 60 years

Greater than 60 years

Age, Customized

Sex: Female, Male

Black or African American

White

Race/Ethnicity, Customized

FLT3-ITD

FLT3-D835

FLT3-ITD and D835

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 status

Number of prior therapies

ECOG 0

ECOG 1

ECOG 2

ECOG performance status graded by the investigator during a physical assessment. A greater ECOG grade is associated with greater impact of the disease on the ability of the subject to live. Grade 0 indicates subjects who are fully active and able to carry on all pre-disease performance. Grade 1 indicates subjects restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 indicates subjects who are ambulatory and capable of all selfcare but unable to carry out any work activities.

Baseline ECOG Performance

Edward McDonald

CR/CRi

ORR (CR+PR)

Clinical Benefit (CR+PR+HI)

Overall Response Rate

Overall Study

Anti-Infective Agents

Analgesics

Cytarabine

Mitoxantrone

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

chemotherapy (MC) in combination with placebo

chemotherapy (MC) in combination with crenolanib

Induction therapy:

* Mitoxantrone 10 mg/m² IV, push (8 mg/m² for patients \> 60 years of age and/or previous allogeneic HCT) d 1-3
* Cytarabine 1000 mg/m² IV (500 mg/m² for patients \> 60 years of age and/or previous allogeneic HCT), over 3 hours, d 1-6

Consolidation therapy:

Younger adult patients (18 to 60 yrs):

Cytarabine 1500 mg/m² by i.v infusion over 3 hours BID on days 1-3 (total dose 9000 mg/m²).

Older patients (\> 60 yrs) and or previous allogeneic HCT:

Cytarabine 1000 mg/m² by i.v. infusion over 3 hours BID on days 1-3 (total dose 6000 mg/m²).

chemotherapy (Mitoxantrone, Cytarabine)

Induction therapy:

Placebo to be given as p.o. TID starting d 7+, given continuously thereafter until 48 hours prior to the next chemotherapy.

Consolidation therapy:

Placebo will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.

Maintenance therapy with placebo is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.

Maintenance with placebo will be given at the same dose tolerated during induction therapy.

Placebo

Induction therapy:

Crenolanib to be given as p.o. TID starting d 7+, given continuously until 48 hours prior to the next chemotherapy.

Consolidation therapy:

Crenolanib will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.

Maintenance therapy with Crenolanib is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.

Maintenance with Crenolanib will be given at the same dose tolerated during induction therapy.

In patients achieving a CR or CRi after salvage-reinduction chemotherapy allogeneic HCT from a matched related or unrelated donor is the preferred form of consolidation. Preferred source of allogeneic HSC are mobilized peripheral blood stem cells. Other forms of allogeneic transplantation (haploidentical donor; cord blood) are allowed.

Allogeneic HCT should be conducted at the earliest time point after the start of the last chemotherapy but no later than after 56 days. A delay of transplant beyond this time window need to be discussed with the Coordinating Investigator. Patients can receive allogeneic HCT directly after salvage re-induction chemotherapy with MC, but also later on following consolidation with IDAC.

Allogeneic stem cell transplantation

The main trial is a double-blinded, placebo-controlled, randomized, phase III, multi-center trial in adult patients with relapsed or refractory AML harboring an activating FLT3 mutation as defined in the inclusion /exclusion criteria.

An initial open label dose-finding run-in phase I of the study will be performed administering the study drug crenolanib with salvage chemotherapy consisting of mitoxantrone and cytarabine (MC) in 18 patients according to the experimental arm of the study. After completion of this dose-finding run-in phase I, toxicity and response data will be provided to the external Data and Safety Monitoring Board (DSMB) and the Trial Committee by the Coordinating Investigator. The Trial Committee will decide on the basis of these data and the recommendation of the DSMB on dose modification and the further conduct of the study with regard to the double-blinded, placebo-controlled, randomized phase of the study.

The double-blinded, placebo-controlled randomized portion will start after the completion of the dose-finding run-in phase I and positive opinion of the Trial Committee.

Crenolanib starts on day 7 of MC and is given continuously until 48 hours prior to the next chemotherapy; if receiving allogeneic HCT, crenolanib is held 48 hours prior to conditioning and restarts no sooner than 30 days and not later than day 100 after transplant.

Sample size randomized phase: 276 patients

Primary objective: To evaluate the impact of crenolanib given in combination with salvage chemotherapy and consolidation including allogeneic hematopoietic cell transplantation and ongoing single agent maintenance therapy with crenolanib on event-free (EFS) and overall survival (OS) in adult patients with relapsed or refractory AML harboring FLT3 activating mutations.

Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Dose-Finding Run-in Phase I Followed by a Phase III, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics (24) at the Screening visit, after last induction cycle, after last consolidation cycle, at end of treatment visit and every year thereafter.

Type, frequency, severity, timing and relatedness of hematologic and non-hematologic toxicities

University of Ulm

Prof. Dr.

Hematologic Neoplasms

Micronutrients

Anti-Inflammatory Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Hematinics

Vitamins

Leucovorin

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Methotrexate

Sorafenib

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antidotes

Protective Agents

Trace Elements

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

All participants who consent and are enrolled on the study.

Interventions: Crenolanib, sorafenib, triple intrathecal chemotherapy (methotrexate, hydrocortisone and cytarabine with leucovorin).

Day 1 of Course 1: once followed by pharmacokinetic analysis. Days 2-28 of cycle 1: 3 times per day Crenolanib dose will not be adjusted unless the participant experiences side effects.

All subsequent courses: 3 times per day on Days 1-28. At least 50% of participants in each dose level must be ≤ 18 years old.

Days 8-28 of course 1: given orally once each day.

All subsequent courses: given orally on days 1-28 once per day

This is a dose-finding study for the use of sorafenib in combination with crenolanib. Different doses will be given to several participants, with the first participants receiving a lower dose than typically used in children as a single agent. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. If side effects occur, the dose will be lowered.

Triple IT therapy includes methotrexate, hydrocortisone and cytarabine with leucovorin rescue given on day 8. All participants will receive one IT chemotherapy on Day 8 of the first cycle. If they do not have leukemia cells in their spinal fluid, they will receive only one IT chemotherapy per cycle. If leukemia cells are present in their spinal fluid, they will receive IT chemotherapy weekly during the course. Triple IT therapy will be repeated on Day 1 of Cycle 2 and with each subsequent cycle in all participants.

methotrexate, hydrocortisone and cytarabine with leucovorin

Hiroto Inaba, MD, PhD

PRIMARY OBJECTIVE:

This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs in patients with relapsed or refractory hematologic malignancies, including acute myeloid leukemia (AML), AML with prior myelodysplastic syndrome (MDS), and myeloperoxidase (MPO)-positive mixed phenotype acute leukemia with FLT3-internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.

The study will include two phases:

* The dose-escalation phase will characterize the dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of crenolanib when given in combination with sorafenib.
* The dose-expansion cohort will further assess the safety and explore the efficacy of this combination.

Each course of therapy will be 28 days (±5 days), unless disease progression is seen while on the combination of crenolanib with sorafenib. Patients may receive subsequent courses (up to a total of 365 days) if there is no disease progression or unacceptable toxicity.

In Day 1 of Course 1, crenolanib is given once in the morning followed by characterization of the pharmacokinetic profile over the following 24-hour period. Starting with day 2 of Course 1, crenolanib will be given 3 times per day through day 28. On Days 8 to 28 of Course 1, sorafenib will be given once per day. Inter-patient dose escalation or de-escalation of crenolanib will be performed based on tolerability and toxicity.

Response will be assessed on days 8 and at end of course. If disease progresses prior to day 8, then sorafenib can be given before day 8.

In subsequent courses (up to 365 days), crenolanib and sorafenib are given on days 1 through 28. The treating physician may increase or decrease the sorafenib dose and frequency of administration per the trial's dosing table on the basis of effects and tolerability. If necessary, the crenolanib dose can be decreased per protocol.

Maintenance therapy must start no sooner than 30 days and no later than 120 days after hematopoietic stem cell therapy (HSCT). Single agent crenolanib will start at the last dose tolerated prior to HSCT. Crenolanib maintenance can be given for up to 365 days and additional therapy can be provided after discussion after discussion with the PI, in patients who continue to benefit after 1 year.

Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies

A Phase I Pharmacokinetic, Pharmacodynamic and Feasibility Study of Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies (ARO-008)

Any participant who experiences DLT at any time during cycle 1 of protocol therapy is considered evaluable for toxicity. Participants without DLT and can be followed for 28 days are also considered evaluable for toxicity. Participants who are not evaluable for toxicity (such as those removed early from therapy to start alternate therapy) at a given dose level will be replaced.

The MTD is empirically defined as the highest dose level at which six participants have been treated with at most one participant experiencing a DLT and the next higher dose has been determined to be too toxic. If the lowest dose level studied is too toxic or the highest dose level studied is considered safe, the MTD will not have been considered estimated.

Ohio State University

St. Jude Children's Research Hospital

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Paclitaxel

Albumin-Bound Paclitaxel

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Crenolanib continuously on Days 1-28 at 1 of 3 BID doses - 60 mg, 80 mg or 100 mg

Ramucirumab IV 8 mg/kg on Days 1 and 15 q28 days

Paclitaxel IV 80 mg/m2 on Days 1, 8 and 15 q28 days

Geoffrey Ku, MD

This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus, GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose expansion phase.

Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

Phase I/Ib Study of Crenolanib With Ramucirumab and Paclitaxel as Second Line Therapy for Advanced Esophagogastric Adenocarcinoma

The DLT is based on the first cycle (35 days) adverse events. If at least 2 of 3 or 2 of up to 6 patients experience a DLT at the starting dose level, then the study will be paused and the starting dose will be re-assessed. The MTD is defined as the highest dose level in which \<2 of 6 patients develop a DLT. This will constitute the first part of the study which will enroll a maximum of 18 patients.

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioma

Brain Neoplasms

Diffuse Intrinsic Pontine Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Brain Stem Neoplasms

Infratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Mitogens

The patients are newly diagnosed Diffuse Intrinsic Pontine Glioma patients. Patients may take crenolanib as an intact tablet or crushed in apple sauce/juice. Currently accruing to dose level 3 (170 mg/m\^2).

The patients are recurrent, refractory or progressive high-grade glioma including Diffuse Intrinsic Pontine Glioma patients. Patients may take crenolanib as an intact tablet or crushed in apple sauce/juice. Currently accruing to dose level 4 (220 mg/m\^2).

Crenolanib orally administered as whole or crushed tablets once per day with concurrent Radiation Therapy. Crenolanib will continue at the same dose level post Radiation Therapy

Alberto Broniscer, MD

This is a Phase I clinical trial evaluating crenolanib (CP-868,596), an inhibitor of Platelet Derived Growth Factor Receptor (PDGFR)-kinase in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) or in recurrent, progressive or refractory High Grade Glioma (HGG) including DIPG (Stratum B). This study drug targets the most commonly amplified region of genome found in DIPG and pediatric high grade glioma (HGG) which encodes for the PDGF receptor kinase. An oral investigational agent crenolanib will be administered daily during and after local radiation therapy (RT) in Diffuse Intrinsic Pontine Glioma DIPG (Stratum A), or daily for children with recurrent/refractory HGG (Stratum B).

Primary Objectives:

* To estimate the maximum tolerated dose (MTD) of crenolanib administered concurrently with RT in pediatric research participants with DIPG
* To estimate the MTD of crenolanib in children and young adults with recurrent/refractory HGG including DIPG
* To characterize the pharmacokinetics of crenolanib in pediatric patients and relate drug disposition to toxicity

Exploratory Secondary Objectives:

* To characterize toxicities and/or adverse events associated with the chronic use of crenolanib
* To evaluate the association between specific polymorphisms of drug metabolizing enzymes and the pharmacokinetics of crenolanib
* To evaluate changes in phosphorylation of targets of PDGF pathway activation in peripheral blood mononuclear cells and investigate the possible relationship between these changes, plasma drug levels of crenolanib and outcome measures
* To evaluate PDGFR, genotype, protein expression and DNA amplification in tumor tissue where available
* To investigate whether magnetic resonance imaging (MRI) techniques that reflect tumor pathophysiology (metabolism, oxygenation, perfusion and vessel wall integrity) are correlated with clinical response
* To characterize the neural tract involvement and tumor progression routes of pediatric brainstem glioma based upon anatomical magnetic resonance imaging and diffusion tensor imaging
* To assess the pattern of failure in radiation therapy in Stratum A participants.
* To describe the research participants' and parents' perspective of symptoms and the quality of life of children enrolled on this phase I trial
* To describe the quality of life and the impact of self-care activities of parents of pediatric research participants enrolled on this phase I trial
* To assess the impact of therapeutic alliance and social support on peace of mind, hope, anxiety/depression and quality of life among parents of pediatric research participants enrolled on this phase I trial

Stratum A- Appropriate dose RT will be administered in 30-33 fractions over approximately 6 weeks for Stratum A patients. Treatment with crenolanib will start on the same day as RT and continue daily during and after Radiation Therapy for a maximum treatment duration of 2 years. We plan to treat a maximum of 5 cohorts of research participants (dosage levels 0, 1, 2, 3, and 4) with escalating doses of crenolanib. A cycle is defined as 28 days and the first 8 weeks of therapy will constitute the dose-limiting toxicity (DLT)-evaluation period.

Stratum B - Crenolanib will be administered orally on a daily basis continuously for 28 days, which defines one cycle. The maximum treatment duration will be 2 years. We plan to treat a maximum of 5 cohorts of research participants (dosage levels 0, 1, 2, 3, and 4) with escalating doses of crenolanib. Dose escalation will be independent of Stratum A escalation. The DLT evaluation period will be four weeks.

PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma

Platelet Derived Growth Factor Receptor (PDGFR) Inhibitor Crenolanib in Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma Including Diffuse Intrinsic Pontine Glioma

Individual pharmacokinetic parameters will be estimated using nonlinear mixed effects modeling methods (NONMEM) to estimate both the inter- and intra-subject variability.

The V Foundation for Cancer Research

Daunorubicin

Idarubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

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.

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

Age, Continuous

Ethnicity (NIH/OMB)

Asian

American Indian or Alaska Native

Other

ITD only

TKD only

ITD and TKD

FLT3 Mutations

Normal

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations	NCT01522469	Relapsed or Ref...	Crenolanib Besy...	18 Years -	Arog Pharmaceuticals, Inc.
Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations	NCT02298166	Acute Myeloid L...	chemotherapy (M... Placebo Crenolanib Allogeneic stem...	18 Years -	University of Ulm
Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies	NCT02270788	Acute Myeloid L...	Crenolanib Sorafenib methotrexate, h...	1 Year - 39 Years	St. Jude Children's Research Hospital
Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma	NCT03193918	Esophagogastric...	Crenolanib Ramucirumab Paclitaxel	18 Years -	Arog Pharmaceuticals, Inc.
Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma	NCT03193918	Esophagogastric...	Crenolanib Ramucirumab Paclitaxel	18 Years -	Arog Pharmaceuticals, Inc.
PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma	NCT01393912	Diffuse Intrins... Progressive or ...	Crenolanib	18 Months - 21 Years	St. Jude Children's Research Hospital
A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations	NCT02283177	Newly Diagnosed...	crenolanib cytarabine daunorubicin idarubicin	18 Years -	Arog Pharmaceuticals, Inc.
A Phase II Study of Crenolanib in Relapsed/Refractory Acute Myeloid Leukemia Patients With FLT3 Activating Mutations	NCT01657682	Acute Myeloid L...	Crenolanib besy...	18 Years -	Arog Pharmaceuticals, Inc.
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS	NCT04477291	Acute Myeloid L... Myelodysplastic...	CG-806	18 Years -	Aptose Biosciences Inc.
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST	NCT02847429	GIST With D842V...	Crenolanib Placebo	18 Years -	Arog Pharmaceuticals, Inc.
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST	NCT02847429	GIST With D842V...	Crenolanib Placebo	18 Years -	Arog Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for crenolanib

Every month we try and update this database with for crenolanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for crenolanib

Every month we try and update this database with for crenolanib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for crenolanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.