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CAR T-cell Therapy
Brexucabtagene Autoleucel + Dasatinib for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Lori Muffly, M.D.
Research Sponsored by Stanford University
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
No Placebo-Only Group
Summary
This trial tests a new treatment for adults with a type of leukemia, which involves taking medication 3 days per week for the first month after an infusion.
Who is the study for?
Adults with B-cell acute lymphoblastic leukemia that's come back or hasn't responded to treatment can join. They need good liver, kidney, heart, and lung function; a normal heartbeat; not pregnant; willing to use birth control for six months after treatment; and no severe active infections or recent serious heart issues.
What is being tested?
The trial tests if taking dasatinib orally for three days a week after getting brexucabtagene autoleucel (Tecartus) is doable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia.
What are the potential side effects?
Possible side effects include liver problems, changes in blood counts leading to increased infection risk or bleeding complications, nausea, rash, muscle pain, fluid retention around the heart or lungs, and potential impact on fertility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of dasatinib pulses
Secondary study objectives
Complete Response (CR)
MRD-negative Complete Response (CR)
Overall Survival (OS) following Tecartus plus dasatinib
+3 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Small intestinal obstruction
2%
Lower gastrointestinal hemorrhage
2%
Fungemia
2%
Peripheral motor neuropathy
2%
Typhlitis
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Kidney infection
2%
Edema limbs
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DasatinibExperimental Treatment1 Intervention
Oral dasatinib 100mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,962 Total Patients Enrolled
Kite PharmaUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Lori Muffly, M.D.Principal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function is good and my bilirubin levels are normal or near normal.My kidneys are working well.My heart is strong and works well.I have brain involvement with changes in my neurological condition.My cancer has spread to my brain but I don't have symptoms.My leukemia did not respond well to initial treatment.I have an autoimmune disease and have been on immunosuppressive drugs in the past year.I have not taken corticosteroids in the week before joining.I have had GVHD needing treatment in the last 4 weeks.I have a genetic condition like Fanconi anemia affecting my bone marrow.My B-precursor ALL has returned after treatment.I have had a bad reaction to dasatinib.I haven't had a heart attack or other major heart issues in the last year.I do not have any severe infections requiring IV antibiotics.My cancer shows CD19 expression and I've been treated with blinatumomab before.I can verbally agree to participate, and I have someone legally authorized to make decisions for me.I have received specific chemotherapy for acute lymphoblastic leukemia within the last week.My leukemia has returned or didn't respond to treatment, confirmed by specific tests.I am 18 years old or older.I am able to get out of my bed or chair and move around.My liver tests are within normal limits.I have a history of brain disorders like seizures or strokes.I have not received a live vaccine in the last 4 weeks.My condition worsened or didn't improve after a stem cell transplant, and it's been over 100 days since the transplant.I have HIV, hepatitis B, or untreated hepatitis C.I have been cancer-free for at least 2 years, except for non-melanoma skin cancer or carcinoma in situ.
Research Study Groups:
This trial has the following groups:- Group 1: Dasatinib
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.
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