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Alkylating agents
Rituximab + Bendamustine/Cytarabine for Mantle Cell Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Candidate for ASCT
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.
Awards & highlights
Study Summary
This trial found that the combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine improved pre-ASCT complete response rates compared to historical rates.
Who is the study for?
This trial is for newly diagnosed, untreated patients with Mantle Cell Lymphoma who are eligible for a stem cell transplant. They must have measurable disease and agree to pathology review at specified hospitals. Excluded are those allergic to rituximab, on other trials, HIV positive on antiretrovirals, pregnant or breastfeeding women, and those with uncontrolled illnesses or prior lymphoma treatment.Check my eligibility
What is being tested?
The study tests Rituximab-Bendamustine followed by Rituximab-Cytarabine in MCL patients to see if it can increase the rate of complete response before stem cell transplantation compared to the historical rate of 55%, while keeping side effects manageable.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever and chills, low blood counts leading to increased infection risk or bleeding problems, nausea, fatigue and possible organ damage due to inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a stem cell transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. median follow-up in this study cohort was 13 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Remission (CR) Rate After 6 Cycles
Secondary outcome measures
1 Year Progression-Free Survival
Autologous Stem Cell Transplant (ASCT) Rate
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: RB/RCExperimental Treatment3 Interventions
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
2 g/m2 for age >60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
1.5 g/m2 for age >60 years old AND creatinine 114.9-176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;
1 g/m2 for age > 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Rituximab
1999
Completed Phase 4
~1880
Bendamustine
2015
Completed Phase 3
~2950
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,849 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,332 Total Patients Enrolled
Philippe Armand, MD, PhDStudy ChairDana-Farber Cancer Institute
4 Previous Clinical Trials
271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking part in another clinical trial.I do not have any unmanaged ongoing illnesses.You are allergic to rituximab.I am eligible for a stem cell transplant.You are pregnant or currently breastfeeding.I am HIV positive and on combination antiretroviral therapy.I have received treatment for lymphoma before.
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.
Research Study Groups:
This trial has the following groups:- Group 1: RB/RC
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what cases is Rituximab commonly prescribed?
"Rituximab has been employed to treat meningeal leukemia, as well as b-cell lymphomas, polyangium and myelocytic, acute leukemia."
Answered by AI
Does this medical trial accept participants of 45 years or younger?
"This clinical trial is reserved for patients aged 18 to 69. Separately, there are 426 trials available that cater exclusively to minors and 2093 trials suitable for seniors over 65 years old."
Answered by AI
Who qualifies to take part in this scientific investigation?
"This clinical trial seeks 23 individuals with a diagnosis of mantle-cell lymphoma, aged 18 to 69. Criteria for participation necessitates both pathologic evaluation at either Brigham and Women's Hospital or Massachusetts General Hospital as well as evidence of measurable disease that is amenable to autologous stem cell transplantation (ASCT)."
Answered by AI
What have been the findings regarding Rituximab's safety profile?
"Our team at Power assessed Rituximab's safety to be a 2 due to the Phase 2 trial that suggests some proof of its relative security, yet it lacks evidence for efficacy."
Answered by AI
Are there any vacancies left in this clinical investigation?
"This trial, which was initially listed on August 16th 2012 and updated June 3rd 2022 is not presently recruiting. However, there are 2,363 other studies actively searching for participants as of now."
Answered by AI
What is the current patient cohort for this research?
"At this time, no more participants are being sought for the study that was initially posted on August 16th 2012. If you're looking to join in a similar trial, there are 1720 studies currently recruiting patients with lymphoma or mantle-cell and 643 trials seeking volunteers to test Rituximab."
Answered by AI
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