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Small Molecule Kinase Inhibitor
Combination Chemotherapy for Lymphoma
Phase 2
Recruiting
Led By Jason Westin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to take aspirin (81 mg) daily or alternative therapy as prophylactic anticoagulation
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time between study entry and death from any cause, assessed up to 2 years post-treatment
Awards & highlights
Study Summary
This trial is testing rituximab, lenalidomide, acalabrutinib, tafasitamab to see if they can help control non-germinal center diffuse large B-cell lymphoma.
Who is the study for?
Adults diagnosed with non-germinal center diffuse large B-cell lymphoma who haven't had treatment, except possibly a short course of steroids or one dose of cyclophosphamide for urgent issues. They must have measurable disease, acceptable liver and kidney function, no significant neuropathy or serious medical conditions, not be pregnant or breastfeeding, able to sign consent form, willing to follow birth control requirements and join the REMS program.Check my eligibility
What is being tested?
The trial is testing rituximab, lenalidomide, acalabrutinib, tafasitamab alone and in combination with chemotherapy drugs (prednisone, doxorubicin hydrochloride, cyclophosphamide, vincristine) for treating newly diagnosed non-germinal center diffuse large B-cell lymphoma. The goal is to see how well these treatments work together in controlling this type of lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions related to monoclonal antibodies like rituximab and tafasitamab; organ inflammation; blood disorders from chemotherapy agents; increased risk of infections due to immune system suppression; fatigue; digestive issues from anti-inflammatory drugs like prednisone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take daily aspirin or a similar medication for blood thinning.
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I am registered and can follow the Revlimid REMS program requirements.
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My cancer can be measured and is larger than 1.5cm.
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I am 18 years or older and can give my consent.
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My kidneys work well enough, with a creatinine clearance of 30ml/min or more.
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I am willing to receive blood transfusions.
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My diagnosis is diffuse large B-cell lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time between study entry and death from any cause, assessed up to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time between study entry and death from any cause, assessed up to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate
Overall response rate
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival
Progression free survival
Side effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (uLTRA, CHOP)Experimental Treatment8 Interventions
COHORT I (SMART STOP): Patients receive rituximab IV over 4-6 hours on day 1, acalabrutinib PO BID on days 1-21, lenalidomide QD on days 1-10, and tafasitamab IV over 2 hours on days 1, 8, and 15. Treatments repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
COHORT II (uLTRA-CHOP): Patients who achieve a complete response to the Smart Stop in Cohort I, receive rituximab IV over 4-6 hours on day 1, acalabrutinib PO BID on days 1-21, lenalidomide QD on days 1-10, and tafasitamab IV over 2 hours on days 1, 8, and 15. Treatments repeat every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, vincristine IV over 15 minutes on day 1, and prednisone PO QD on days 1-5. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progr
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Tafasitamab
2016
Completed Phase 2
~180
Vincristine
2003
Completed Phase 4
~2910
Acalabrutinib
2020
Completed Phase 2
~2050
Cyclophosphamide
1995
Completed Phase 3
~3770
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,286 Total Patients Enrolled
Jason WestinPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
113 Total Patients Enrolled
Jason Westin, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take certain medications or treatments due to other health issues.I have only had limited radiotherapy, short-term steroids, or a single dose of cyclophosphamide for urgent issues.I can take daily aspirin or a similar medication for blood thinning.I need to take medication for stomach acid, like omeprazole.I have not received any live vaccines in the last 4 weeks.I am registered and can follow the Revlimid REMS program requirements.I have severe slow heart rate, low blood pressure, or fainting spells.My cancer can be measured and is larger than 1.5cm.I am allergic to specific cancer drugs like lenalidomide or thalidomide.I need ongoing treatment with strong medications that affect liver enzymes.I have not had a blood clot in my lungs or deep veins in the last 30 days.I am a woman who can have children and have a negative pregnancy test.My lymphoma has spread to my brain or spinal cord.I have severe nerve pain or discomfort recently.I am 18 years or older and can give my consent.I have not had major surgery in the last 4 weeks and all my wounds from past surgeries or injuries are healed.I have not had a stroke or brain bleed in the last 6 months.My kidneys work well enough, with a creatinine clearance of 30ml/min or more.I am willing to receive blood transfusions.I do not have a bleeding disorder like hemophilia.I have uncontrolled AIHA or ITP.I am using or willing to use effective birth control during and after the study.I have HIV and my hepatitis status meets the study's requirements.My liver functions are within safe ranges and I have enough white blood cells and platelets.I need warfarin or a similar drug for blood thinning.My diagnosis is diffuse large B-cell lymphoma.I do not have any serious health conditions that are uncontrolled or would interfere with the trial.I had cancer in the past 2 years, but it was either skin cancer treated successfully or another type now in remission.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (uLTRA, CHOP)
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 other clinical examinations have been conducted utilizing Rituximab?
"At present, 1750 clinical trials are being conducted to study the efficacy of Rituximab. Of these, 377 have entered Phase 3 and can be found across 69161 locations with a majority in Joliet, Illinois."
Answered by AI
Has the FDA sanctioned Rituximab as a safe and effective drug?
"The safety of Rituximab has been estimated by the Power team to be a 2, as its efficacy is yet unproven but some supporting data exists for its safety."
Answered by AI
What types of treatments is Rituximab commonly prescribed for?
"Rituximab can be employed to treat pheochromocytomas, ulcerative colitis, as well as varicella-zoster virus acute retinal necrosis."
Answered by AI
Are there opportunities to become involved in this investigation?
"Affirmative. Clinicaltrials.gov data corroborates that this research is actively recruiting, with the first listing being posted on March 3rd 2022 and last update occurring on July 10th of the same year. The study requires 60 individuals from a single medical facility to participate in its activities."
Answered by AI
What is the scope of subjects currently under evaluation in this clinical exploration?
"Affirmative. According to information in clinicaltrials.gov, this medical study initially opened for recruitment on March 3rd 2022 and has recently been updated on July 10th 2022. This research requires 60 participants based at a single site."
Answered by AI
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