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Kinase Inhibitor
Triple Therapy for Chronic Lymphocytic Leukemia
Phase 1
Recruiting
Led By Stephen E Spurgeon
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years
Awards & highlights
Study Summary
This trial tests if giving 3 drugs together helps kill cancer cells in newly-diagnosed CLL patients.
Who is the study for?
This trial is for adults with previously untreated chronic lymphocytic leukemia (CLL). Participants must not have had any prior CLL treatment, be able to swallow pills, and agree to use contraception. They should have a life expectancy over 12 months and meet specific health criteria like adequate organ function. Those with certain other cancers or severe medical conditions are excluded.Check my eligibility
What is being tested?
The trial tests the combination of tafasitamab, acalabrutinib, and obinutuzumab in treating CLL. These drugs include monoclonal antibodies that may stop cancer cells from growing and a kinase inhibitor that blocks abnormal proteins in B-cell cancers.See study design
What are the potential side effects?
Potential side effects could include reactions related to the immune system such as infusion reactions, infections due to lowered immunity, liver issues indicated by changes in blood tests, fatigue, digestive problems like nausea or diarrhea, and possibly bleeding complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib 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
Incidence of dose limiting toxicities (DLTs)
Proportion of patients that achieve minimal residual disease (MRD) negativity in peripheral blood
Secondary outcome measures
Objective response rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tafasitamab, obinutuzumab, acalabrutinib)Experimental Treatment9 Interventions
Patients receive obinutuzumab IV over a rate titrated up to 400 mg/hour on days 1, 2, 8, and 15 for cycle 1 then on day 1 for cycles 2-6 and tafasitamab IV over 1.5-2 hours on days 1, 4, 8, 15, and 22 for cycle 2, on days 1, 8, 15, and 22 for cycles 3-4, and on days 1 and 15 for cycles 5-7. Patients also receive acalabrutinib PO BID in each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT throughout the trial. Patients may undergo an ECHO at baseline as clinically indicated and may also undergo bone marrow biopsy and/or aspiration at baseline and/or follow-up
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Tafasitamab
2016
Completed Phase 2
~180
Acalabrutinib
2020
Completed Phase 2
~2050
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,701 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
974 Previous Clinical Trials
7,385,887 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow is failing or I have symptoms related to my disease.I am currently taking proton pump inhibitors.I have or had another blood cancer diagnosis.I have not received a live vaccine in the last 14 days.I do not have any ongoing widespread infections.I have a bleeding disorder.I am 18 years old or older.I can swallow and keep down pills.My cancer has a specific gene signature detectable by a test.I have swollen lymph nodes that can be measured.I have received treatment for CLL, but only used allowed steroids.I haven't taken certain medications or inhibitors recently.I am on high-dose medication for my autoimmune disease.My CLL diagnosis is confirmed and I haven't received any treatment yet.I meet at least one guideline for CLL treatment.I can take care of myself but might not be able to do heavy physical work.I have a history of certain solid tumors or specific health conditions.I have a history of PML.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tafasitamab, obinutuzumab, acalabrutinib)
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.
Is this investigation currently recruiting participants?
"The information posted to clinicaltrials.gov reveals that this study is not presently accepting applicants, though it originally became available on August 1st 2023 and was last modified on July 5th 2023. While applications are being rejected for this trial, there are 1528 other trials currently recruiting patients at the moment."
Answered by AI
Are the effects of tafasitamab, obinutuzumab, and acalabrutinib regulated by the FDA?
"As this is a Phase 1 trial, with only limited efficacy and safety data available, our team at Power judged the Treatment (tafasitamab, obinutuzumab, acalabrutinib) to be of relatively low risk with a score of 1."
Answered by AI
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