Your session is about to expire
← Back to Search
Chemotherapy Agent
Gilteritinib + Chemotherapy for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For subject undergoing hematopoietic stem cell transplant (HSCT), at least 90 days must have elapsed since HSCT and subject must not have active graft-versus-host disease (GVHD).
Prior to screening, 90 days must have elapsed if the subject had a prior traumatic brain injury or has received craniospinal XRT.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will study gilteritinib in combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) to see if it is safe and effective in treating people with relapsed or refractory acute myeloid leukemia (AML).
Who is the study for?
This trial is for children, adolescents, and young adults aged ≥6 months to <21 years with FLT3/ITD positive relapsed or refractory AML. They must have recovered from prior treatments, not be pregnant or breastfeeding, agree to use contraception, and not have active CNS leukemia or significant heart disease.Check my eligibility
What is being tested?
The study tests gilteritinib combined with chemotherapy (fludarabine, cytarabine, G-CSF) in two phases: Phase 1 finds the safest dose; Phase 2 checks how well it works. It measures remission rates after two cycles and monitors safety over a potential two-year treatment period.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drug combination (like inflammation), digestive issues due to chemotherapy agents used alongside gilteritinib, liver function changes, blood disorders such as anemia or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It's been over 90 days since my stem cell transplant and I don't have active GVHD.
Select...
It has been over 90 days since my last brain injury or craniospinal radiation.
Select...
My blood or bone marrow has a FLT3 mutation.
Select...
My liver enzymes, AST and ALT, are within normal limits.
Select...
I have been diagnosed with a type of leukemia called AML with at least 5% cancer cells in my bone marrow.
Select...
My AML did not respond to the first treatment or it has returned after initial success.
Select...
I am receiving a specific chemotherapy at a low dose.
Select...
My blood or bone marrow has the FLT3 mutation.
Select...
I am between 6 months and 21 years old.
Select...
My total bilirubin levels are within normal range for my age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Remission (CR) rate after 2 cycles of therapy (phase 2)
Composite complete remission (CRc) rate after 2 cycles of therapy (phase 2)
Number of participants with dose limiting toxicity (DLT) (phase 1/dose escalation)
Secondary outcome measures
Clinical Outcome Assessment of Taste
Duration of Event Free Survival (EFS)
Duration of Overall survival (OS)
+14 moreSide effects data
From 2021 Phase 1 & 2 trial • 11 Patients • NCT03730012100%
Dyspnoea
100%
Muscular weakness
100%
Febrile neutropenia
100%
Decreased appetite
100%
Dizziness
67%
Oedema peripheral
67%
Confusional state
67%
Epistaxis
67%
Delirium
67%
Insomnia
67%
Fatigue
67%
Neck pain
67%
Contusion
67%
Abdominal pain
67%
Constipation
67%
Arthralgia
67%
Weight decreased
67%
Rash maculo-papular
67%
Hypertension
67%
Hypotension
33%
Diarrhoea
33%
Enterococcal infection
33%
Cerebrovascular accident
33%
Device leakage
33%
Malaise
33%
Non-cardiac chest pain
33%
Anxiety
33%
Depression
33%
Hyperuricaemia
33%
Sepsis
33%
Hypertriglyceridaemia
33%
Hypoxia
33%
Rales
33%
Supraventricular extrasystoles
33%
Nodule
33%
Paraesthesia
33%
Ocular icterus
33%
Blood lactate dehydrogenase increased
33%
Dehydration
33%
Hepatitis
33%
Rhinitis allergic
33%
Bacteraemia
33%
Sinus tachycardia
33%
Fall
33%
Chloroma
33%
Tremor
33%
Multiple organ dysfunction syndrome
33%
Arrhythmia supraventricular
33%
Hyperglycaemia
33%
Sinus bradycardia
33%
Head injury
33%
Pyrexia
33%
Localised oedema
33%
Hepatomegaly
33%
Anaemia
33%
Peripheral sensory neuropathy
33%
Pneumonia
33%
Aphasia
33%
Subdural haematoma
33%
Aspartate aminotransferase increased
33%
Dry eye
33%
Dry mouth
33%
Dyspepsia
33%
Flatulence
33%
Oral pain
33%
Paraesthesia oral
33%
Bacterial test positive
33%
Blood alkaline phosphatase increased
33%
Acidosis
33%
Hypoalbuminaemia
33%
Hypomagnesaemia
33%
Hyponatraemia
33%
Back pain
33%
Muscle spasms
33%
Musculoskeletal chest pain
33%
Lethargy
33%
Memory impairment
33%
Haematuria
33%
Pollakiuria
33%
Cough
33%
Nasal congestion
33%
Oropharyngeal pain
33%
Productive cough
33%
Upper-airway cough syndrome
33%
Hyperhidrosis
33%
Infusion related reaction
33%
Squamous cell carcinoma
33%
Endocarditis
33%
Platelet count decreased
33%
Respiratory syncytial virus test positive
33%
Somnolence
33%
Syncope
33%
Skin ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gilteritinib 120 mg + Atezolizumab 420 mg
Gilteritinib 120 mg + Atezolizumab 840 mg
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment4 Interventions
Participants will be administered fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) chemotherapy on days -1 to 5 and gilteritinib will be administered once per day on days 8 to 21 at the dose determined in dose escalation portion. Participants may receive prophylactic intrathecal cytarabine at the start of the cycle, as per institutional standards. A participant completing 2 cycles (cycle is defined as 28 days) will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
Group II: Dose Escalation - 6 months to less than 1 year of ageExperimental Treatment4 Interventions
Participants will be administered fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) chemotherapy on days -1 to 5 and gilteritinib will be administered once per day on days 8 to 21 at the assigned dose. Participants may receive prophylactic intrathecal cytarabine at the start of the cycle, as per institutional standards. A participant completing 2 cycles (cycle is defined as 28 days) will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
Group III: Dose Escalation - 2 years to less than 21 years of ageExperimental Treatment4 Interventions
Participants will be administered fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) chemotherapy on days -1 to 5 and gilteritinib will be administered once per day on days 8 to 21 at the assigned dose. Participants may receive prophylactic intrathecal cytarabine at the start of the cycle, as per institutional standards. A participant completing 2 cycles (cycle is defined as 28 days) will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
Group IV: Dose Escalation - 1 year to less than 2 years of ageExperimental Treatment4 Interventions
Participants will be administered fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) chemotherapy on days -1 to 5 and gilteritinib will be administered once per day on days 8 to 21 at the assigned dose. Participants may receive prophylactic intrathecal cytarabine at the start of the cycle, as per institutional standards. A participant completing 2 cycles (cycle is defined as 28 days) will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gilteritinib
2016
Completed Phase 3
~430
fludarabine
2012
Completed Phase 3
~6760
cytarabine
1997
Completed Phase 3
~10270
granulocyte colony-stimulating factor (G-CSF)
2014
Completed Phase 2
~890
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,989 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development
2,777 Previous Clinical Trials
8,063,647 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing infection that hasn't improved with treatment, but I've been off pressors and had negative blood cultures for 48 hours.It's been over 90 days since my stem cell transplant and I don't have active GVHD.My blood or bone marrow has a FLT3 mutation.I will not donate eggs during and for 6 months after the study.My liver enzymes, AST and ALT, are within normal limits.I need medication that strongly affects certain liver enzymes and proteins.It's been over a week since I last received treatment with growth factors.I am allergic to gilteritinib, cytarabine, fludarabine, G-CSF, or their ingredients.I will not donate sperm during and for 4 months after the study.I do not have serious heart problems.My potassium or magnesium levels are low, but I can take supplements to increase them.I have been diagnosed with a type of leukemia called AML with at least 5% cancer cells in my bone marrow.I have received X-ray treatment.I am not planning to receive any cancer treatment outside of what this study involves.I am currently being treated for or have significant ongoing issues from a transplant complication.I have active leukemia in my brain or spinal cord.I have recovered from side effects of my previous cancer treatments.I tested negative for active hepatitis B but had it before, and my viral load is undetectable.I am not pregnant and meet one of the specific conditions for the study.I am between 6 months and 2 years old, eligible based on phase 1 results.It has been over 90 days since my last brain injury or craniospinal radiation.I have waited the required time after stopping any experimental treatment before starting gilteritinib.I have taken FLT3 inhibitors like lestaurtinib or sorafenib.My high blood pressure is not under control.My AML did not respond to the first treatment or it has returned after initial success.I am mostly able to care for myself, despite my age or leukemia.It has been over 6 weeks since I received any live vaccines.I have or might have a heart condition that affects my heartbeat's timing.I have cancer types other than acute myeloid leukemia.I am a man who will use birth control during and for 6 months after treatment.I can start a specific treatment to reduce my tumor up to 24 hours before my main therapy begins.I am receiving a specific chemotherapy at a low dose.I have a history of serious heart rhythm problems but I have a pacemaker.My blood or bone marrow has the FLT3 mutation.My cancer has returned or didn't respond after 1 initial treatment attempt.I am between 6 months and 21 years old.I have active hepatitis B, C, or another liver condition.I had local XRT for CNS chloromas more than 14 days ago.I am known to have HIV.I am not currently on chemotherapy that lowers my blood cell counts.I am on low dose or maintenance therapy as recommended by my doctor.I am taking hydroxyurea.It's been over 21 days since my last chemotherapy, or I've recovered sooner.It's been over a week since my last biologic cancer treatment.My total bilirubin levels are within normal range for my age.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 180 days after.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation - 2 years to less than 21 years of age
- Group 2: Dose Escalation - 1 year to less than 2 years of age
- Group 3: Dose Escalation - 6 months to less than 1 year of age
- Group 4: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial encompass participants under the age of forty?
"The requisite standard for entry in this medical study is that candidates must be between 6 months and 21 years of age. Clinicaltrials.gov states there are 701 trials seeking participants under 18, while 1,715 experiments target individuals over 65."
Answered by AI
Are there any opportunities for enrollment in this trial presently?
"That is correct. According to clinicaltrials.gov, this medical trial opened up for recruitment on February 27th 2020 and the latest update was posted November 15th 2022. The study requires 97 participants from 5 different sites."
Answered by AI
What additional research has been conducted utilizing gilteritinib?
"Gilteritinib was initially researched back in 1997 at the City of Hope Comprehensive Cancer Center. Since then, 1172 studies have been completed and 672 are currently live across research centres, with a significant number being located within Nashville and Ohio."
Answered by AI
What qualifications do participants need to fulfill in order to be eligible for this trial?
"This medical trial is recruiting 97 individuals aged 6 months to 21 years old with a diagnosis of acute myeloid leukemia (AML) in the French-American-British classification, displaying at least 5% blasts in their bone marrow. In addition, participants must have recovered from any prior chemotherapy or radiotherapy and should not be actively experiencing CNS leukemia. During Phase 1, patients can only be enrolled if they are in first relapse or resistant to induction therapy with no more than one attempt at remission induction. For those that experience relapse during cytotoxic therapy treatment, there needs to be a minimum of 21 days since its completion before screening for study"
Answered by AI
How many research sites are currently conducting this experiment?
"Sarah Cannon Research Institute in Nashville, Ohio; Cincinnati Childrens Hospital Medical Centre in Cincinatti, Pennsylvania and The Children's Hospital of Philadelphia (CHOP) in Philadelphia Quebec are the primary sites for this trial. Additionally, there are 5 other locations participating as well."
Answered by AI
What therapeutic applications is gilteritinib typically utilized for?
"Gilteritinib can not only help patients recovering from bone marrow transplantations, but also those suffering from febrile neutropenia, generalised neutropenia and recurrent infections."
Answered by AI
Is there a cap on the amount of participants in this clinical investigation?
"To successfully complete this clinical trial, 97 qualifying patients are necessary. It is being organised by Astellas Pharma Global Development, Inc., with Sarah Cannon Research Institute in Nashville and Cincinnati Children's Hospital Medical Center located within Pennsylvania both offering their services to the project."
Answered by AI
What are the prospective outcomes of this experimental study?
"The primary outcome of this trial, which is to be evaluated over a period not exceeding 56 days, will assess the Complete Remission (CR) rate after two cycles of therapy. Secondary objectives include ascertaining how many participants experienced adverse events or abnormalities in vital signs as well as analysing Event Free Survival and any laboratory value abnormalities/adverse events that may have arisen from their participation."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger