Your session is about to expire
← Back to Search
Bruton's Tyrosine Kinase (BTK) Inhibitor
Chemotherapy Combinations for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Led By Nina D Wagner-Johnston
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients are ineligible if they have any of the following: Malabsorption syndrome or disease significantly affecting gastrointestinal function, Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease), Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura), Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug, History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug, Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), History of severe allergic reaction attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine, cytarabine, or acalabrutinib
Patients may not have received the following within 7 days prior to the first dose of study drug: Strong and moderate CYP3A inhibitors, Strong and moderate CYP3A inducers.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years post randomization
Awards & highlights
Study Summary
This trial is testing different combinations of chemotherapy drugs and monoclonal antibodies to treat mantle cell lymphoma.
Who is the study for?
This trial is for adults with newly diagnosed mantle cell lymphoma. Participants should be in good physical condition (ECOG score 0-2), have acceptable blood counts, liver and kidney function, and not be pregnant or breastfeeding. They must agree to use contraception and cannot have certain heart conditions, active infections, bleeding disorders, severe allergies to the drugs being tested, or be on specific medications that affect drug metabolism.Check my eligibility
What is being tested?
The study compares three chemotherapy regimens using bendamustine, rituximab, high dose cytarabine, and acalabrutinib to see which works best for treating mantle cell lymphoma. It aims to determine if these combinations are more effective than current treatments by stopping cancer cells from growing.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site; low blood counts leading to increased infection risk; fatigue; nausea; liver issues; allergic reactions; potential heart problems due to some of the drugs used in treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.
Select...
I am able to care for myself and perform daily activities.
Select...
I agree to use effective birth control or abstain from sex during and for 12 months after the study.
Select...
My hepatitis B virus is under control with treatment.
Select...
You are not eligible for the study if you have any of the following conditions: problems with absorbing nutrients, a history of bleeding disorders or anemia, autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura that is not under control, taking blood thinners such as warfarin within 7 days of starting the study drug, significant cerebrovascular disease or events within 6 months before starting the study drug, active infections that are not responding to treatment, severe allergic reaction to similar drugs like rituximab, bendamustine, cytarabine, or acalabrutinib.
Select...
My lymphoma is confirmed to be mantle cell type with specific genetic markers.
Select...
I am not on strong medications that affect liver enzyme CYP3A.
Select...
I can provide a tissue sample from my initial diagnosis or a blood sample for the study.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.
Select...
I agree to use effective birth control or abstain from sex during and for 12 months after the study.
Select...
My lymphoma is confirmed to be mantle cell type with specific genetic markers.
Select...
I am not on strong medication that affects liver enzyme CYP3A.
Select...
I will switch from proton pump inhibitors before starting acalabrutinib.
Select...
My lymphoma is only in my liver and can be measured.
Select...
I will switch from proton pump inhibitors before starting acalabrutinib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate
Secondary outcome measures
Incidence of adverse events
Mobilization failure rate
Objective response rate (ORR)
+2 moreOther outcome measures
Change of qPET parameters
Incremental prognostic value of baseline qPET to Ki67
Incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI])
+5 moreSide effects data
From undefined Phase 3 trial • 1734 Patients • NCT0002525980%
Neutrophil count decreased
42%
Anemia
31%
Platelet count decreased
26%
Febrile neutropenia
18%
White blood cell decreased
16%
Infections and infestations - Other, specify
9%
Blood and lymphatic system disorders - Other, specify
5%
Lymphocyte count decreased
3%
Catheter related infection
3%
Dehydration
2%
Abdominal pain
2%
Mucositis oral
2%
Vomiting
2%
Anaphylaxis
2%
Hypokalemia
2%
Hypotension
1%
Hypoxia
1%
Depression
1%
Hyponatremia
1%
Immune system disorders - Other, specify
1%
Myalgia
1%
Dizziness
1%
Constipation
1%
Esophagitis
1%
Ileus
1%
Pain
1%
Carbon monoxide diffusing capacity decreased
1%
Hypoalbuminemia
1%
Neuralgia
1%
Peripheral sensory neuropathy
1%
Dyspnea
1%
Diarrhea
1%
Typhlitis
1%
Hyperglycemia
1%
Headache
1%
Seizure
1%
Syncope
1%
Nausea
1%
Cardiac disorders - Other, specify
1%
Hypophosphatemia
1%
Bone pain
1%
Peripheral motor neuropathy
1%
Thromboembolic event
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm III (RER With CR [ABVE-PC])
Arm I (Patients Off-therapy Before Callback-Induction Only)
Arm II (RER With CR [ABVE-PC, IFRT])
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
Arm VII (SER [ABVE-PC, IFRT])
Arm VI (SER [DECA, ABVE-PC, IFRT])
Arm V (RER With PD)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (acalabrutinib, bendamustine, rituximab)Experimental Treatment4 Interventions
Patients receive acalabrutinib PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (acalabrutinib, bendamustine, rituximab, cytarabine)Experimental Treatment5 Interventions
Patients receive PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive acalabrutinib PO BID on days 1-7 and 22-28, rituximab IV on day 1, and cytarabine IV Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (bendamustine, rituximab, cytarabine)Experimental Treatment4 Interventions
Patients receive bendamustine IV on days 1 and 2 and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive rituximab IV on day 1 and cytarabine IV every Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Bendamustine
FDA approved
Acalabrutinib
FDA approved
Bendamustine
FDA approved
Rituximab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,793 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,562 Total Patients Enrolled
Nina D Wagner-JohnstonPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not eligible for the study if you have any of the following conditions: problems with absorbing nutrients, a history of bleeding disorders or anemia, autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura that is not under control, taking blood thinners such as warfarin within 7 days of starting the study drug, significant cerebrovascular disease or events within 6 months before starting the study drug, active infections that are not responding to treatment, severe allergic reaction to similar drugs like rituximab, bendamustine, cytarabine, or acalabrutinib.My heart function is classified as class 2B or better, despite any history of heart issues or treatments.I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.I am able to care for myself and perform daily activities.I agree to use effective birth control or abstain from sex during and for 12 months after the study.My kidney function tests are within normal limits or my GFR is 40 or above.My blood clotting tests are within the normal range, not on warfarin.My hepatitis B virus is under control with treatment.I am HIV positive, on treatment, and my viral load is undetectable.My lymphoma is confirmed to be mantle cell type with specific genetic markers.I am not pregnant or breastfeeding and do not plan to become pregnant or father a child for the next year.I have another cancer type, but it won't affect this cancer treatment's safety or results.My heart function is classified as class 2B or better, despite my history of cardiac issues or treatments.I am not on strong medications that affect liver enzyme CYP3A.My heart's electrical cycle is within a safe range.I am not pregnant or breastfeeding and do not plan to become pregnant or father a child while on the study and for 12 months after.I can provide a tissue sample from my initial diagnosis or a blood sample for the study.My blood clotting tests are within the normal range, or I'm on certain blood thinners.I can provide a tissue sample from my initial diagnosis or a blood sample for the study.I am HIV positive, on treatment, and my viral load is undetectable.I have had recent scans showing measurable cancer.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I can take care of myself and am up and about more than half of my waking hours.My kidney function tests are within normal limits or my GFR is 40 or above.My bilirubin levels are within the normal range or slightly above if I have liver issues.My hepatitis B virus load is undetectable with treatment.I haven't taken strong or moderate CYP3A inhibitors or inducers in the last week.I agree to use effective birth control or abstain from sex during and for 12 months after the study.My lymphoma is confirmed to be mantle cell type with specific genetic markers.My heart's electrical system is functioning within a safe range.I am not on strong medication that affects liver enzyme CYP3A.I will switch from proton pump inhibitors before starting acalabrutinib.My lymphoma is only in my liver and can be measured.I have another cancer type, but it won't affect this trial's treatment.I will switch from proton pump inhibitors before starting acalabrutinib.My white blood cell count is healthy enough for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (bendamustine, rituximab, cytarabine)
- Group 2: Arm C (acalabrutinib, bendamustine, rituximab)
- Group 3: Arm B (acalabrutinib, bendamustine, rituximab, cytarabine)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Have there been any prior studies involving the use of Cytarabine?
"Since its initial study at the National Institutes of Health Clinical Center in 1993, cytarabine has been studied 1291 times. There are currently 724 ongoing studies, with a significant amount taking place around Battle Creek, Michigan."
Answered by AI
How many research centers have joined this investigation?
"This clinical research project is recruiting from a total of 100 medical centres, with prominent locations such as Bronson Battle Creek in Battle Creek, OSF Saint Francis Radiation Oncology at Peoria Cancer Center in Peoria and Wayne State University/Karmanos Cancer Institute in Detroit."
Answered by AI
To what degree is Cytarabine hazardous to human health?
"As this is a Phase 2 trial, with some evidence suggesting that Cytarabine may be safe but no data supporting its efficacy, Power assigned it a safety rating of 2."
Answered by AI
What is the aggregate participant count of this trial?
"Indeed, clinicaltrials.gov indicates that this medical exploration is still enrolling participants. Initially posted on October 3rd 2019 and most recently updated on August 9th 2022, the study aims to recruit 369 patients from 100 sites worldwide."
Answered by AI
Are there any available slots in this study for participants?
"Affirmative. Clinicaltrials.gov data reveals that this clinical trial, which was initially advertised on October 3rd 2019, is still open for recruitment. A total of 369 participants need to be enrolled from 100 sites around the world."
Answered by AI
Is there an age restriction for enrolment in this clinical trial?
"This trial is only available to those between 18 and 70. Accordingly, there are 435 clinical trials specifically tailored for minors while 2,171 trials have been developed with the elderly in mind."
Answered by AI
Could I potentially qualify for this research endeavor?
"In order to be accepted for this trial, applicants must have been diagnosed with lymphoma and fit within the age parameters of 18-70. A total of 369 individuals are required for successful enrolment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger