Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Combination Therapy for Acute Lymphoblastic Leukemia
Phase 1
Recruiting
Led By Jessica T Leonard
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to take oral medication
Eastern Cooperative Oncology Group (ECOG) status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing the effects of a combination of drugs on patients with a specific type of leukemia. The drugs may work by stopping the growth of cancer cells or by interfering with the ability of cancer cells to grow and spread.
Who is the study for?
Adults with newly diagnosed or relapsed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) can join this trial. They must have good kidney function, no prior dasatinib treatment for relapsed cases, and be able to take oral medication. Pregnant or breastfeeding individuals, those with certain heart conditions, recent other cancer treatments, or active serious infections cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination of venetoclax with dasatinib, prednisone, and rituximab in patients. Venetoclax targets proteins that cancer cells need to survive; dasatinib blocks enzymes for cell growth; prednisone lowers immune response; rituximab may stop cancer spread.See study design
What are the potential side effects?
Possible side effects include risk of infection due to lowered immunity from prednisone and rituximab. Venetoclax might cause digestive issues or fatigue. Dasatinib could lead to fluid retention and muscle pain. Each drug has its own profile of potential side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidneys work well, with a creatinine clearance of 50 mL/min or more.
Select...
I have B-cell acute lymphoblastic leukemia with the Philadelphia chromosome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Incidence of dose-limiting toxicities
Secondary outcome measures
Duration of complete molecular response (CMR)
Overall survival
Progression-free survival
+1 moreOther outcome measures
Cell viability percentage
Distribution of gene mutations
Frequency of BCR-ABL fusion protein subtypes
+2 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (prednisone, dasatinib, venetoclax, rituximab)Experimental Treatment9 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumbar Puncture
2016
Completed Phase 3
~510
Biospecimen Collection
2004
Completed Phase 2
~1730
Blinatumomab
2014
Completed Phase 3
~1210
Dasatinib
2012
Completed Phase 3
~2320
Methotrexate
2013
Completed Phase 4
~3800
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
955 Previous Clinical Trials
501,210 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,009 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,706 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take pills by mouth.I haven't taken any experimental cancer treatments recently.I am not pregnant or breastfeeding.I can take care of myself but might not be able to do heavy physical work.You have had allergic reactions to drugs similar to dasatinib or other drugs being used in the study.My kidneys work well, with a creatinine clearance of 50 mL/min or more.I can take pills without issues absorbing them.I have a specific type of advanced leukemia.I have fluid buildup in the lining of my lungs or heart.I do not have any serious heart conditions like heart failure or irregular heartbeats.I am over 100 days post-stem cell transplant and not on active GVHD treatment except for topical meds.I am 18 years old or older and open to all genders and ethnicities.I have ALL and have been treated with chemotherapy, radiotherapy, immunotherapy, or dasatinib.I haven't taken certain strong medications or supplements in the last week.I have HIV, HBV, or HCV but am under effective treatment with an undetectable viral load.I haven't had cancer in the past year, except for certain treated early-stage cancers.I have B-cell acute lymphoblastic leukemia with the Philadelphia chromosome.I have newly diagnosed ALL and have only been treated with steroids, hydrea, or IT methotrexate.I have relapsed disease and have not been treated with dasatinib, but may have received other tyrosine kinase inhibitors.My condition is not due to leukemia.My condition is not due to leukemia affecting my organs.I have been diagnosed with a long QT syndrome.I am currently on antibiotics for a serious infection, not including treatment for neutropenic fever.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (prednisone, dasatinib, venetoclax, rituximab)
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.
What is the estimated sample size for this experiment?
"True. Clinicaltrials.gov attests that this clinical trial is actively recruiting applicants, which started on October 2nd 2022 and was last updated August 17th 2022. Recruitment entails 20 patients from a single medical facility."
Answered by AI
Has Venetoclax been given the regulatory OK by the Food and Drug Administration?
"Given that this is a Phase 1 trial, the safety of Venetoclax has been rated as a 1 on our scale due to limited data in regards to both its efficacy and security."
Answered by AI
What medical conditions have been most frequently addressed by Venetoclax treatments?
"Venetoclax is a common therapy for ulcerative colitis, but also can be beneficial in treating other conditions like varicella-zoster virus acute retinal necrosis, hematopoietic stem cells and subarachnoid block."
Answered by AI
Is the research team currently seeking participants for this study?
"According to information present on clinicaltrials.gov, applicants are actively being sought for this trial which was initially posted in October of 2022 and recently updated in August."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger