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Rituximab + Stem Cell Transplant for Mantle Cell Lymphoma
Study Summary
This trial is testing if rituximab works better with or without stem cell transplant for mantle cell lymphoma in patients who are in first complete remission.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 665 Patients • NCT00567567Trial Design
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Who is running the clinical trial?
Media Library
- I have completed at least 4 cycles of initial cancer treatment.I am not pregnant or breastfeeding.I am using or willing to use effective birth control during the study.I have been cancer-free for over 3 years, except for certain low-risk types or stable prostate cancer.I finished my initial cancer treatment within the last 4 months and started it no more than 10 months ago. If I'm assigned to certain treatment groups, my transplant was within a year of starting treatment.I am HIV positive and meet all required health criteria.My cancer responded to initial treatment without showing signs of getting worse.I started or finished my initial cancer treatment within the last 60 days, and it has been less than 300 days since I began this treatment.My scans show my cancer has responded well to treatment.I have a preserved tissue sample from my initial diagnosis for testing.My doctor thinks I am a good candidate for a stem cell transplant.I have had up to two chemotherapy treatments and my cancer responded to them without stopping.My lymphoma is confirmed to be mantle cell type with specific genetic markers.My lymphoma has not spread to my brain or spinal cord.I can take care of myself and am up and about more than half of my waking hours.I meet the health requirements for a stem cell transplant.
- Group 1: Group II (rituximab alone)
- Group 2: Group I (auto-HCT, rituximab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Does this research project have more than one location in this state?
"There are many hospitals participating in this trial, but to list a few; Saint Louis University Hospital (Saint Louis, Missouri), The James Graham Brown Cancer Center at University of Louisville (Louisville, Kentucky), and Marshfield Medical Center-Rice Lake (Rice Lake, Wisconsin) are just some of the 100 other locations."
Could you explain what Autologous Hematopoietic Stem Cell Transplantation is commonly used to treat?
"Autologous Hematopoietic Stem Cell Transplantation is a treatment that uses the patient's own stem cells. It is most often used to treat dlbcl, but can also be used for other conditions such as b-cell lymphomas, polyangium, and pemphigus vulgaris."
Does Autologous Hematopoietic Stem Cell Transplantation have a lot of risks?
"There is prior clinical data supporting Autologous Hematopoietic Stem Cell Transplantation's safety, so it received a score of 3."
Are people who are 30 years or older being recruited for this clinical trial?
"The age requirements for this trial are that patients must be over 18 years old and cannot be above the age of 70."
How many patients are approved to enroll in this clinical trial?
"Accurate, the listing on clinicaltrials.gov does show that this trial is actively recruiting patients. The posting date was 8/29/2017 with the most recent edit on 12/22/2021. 100 medical sites are looking to enroll a total of 689 individuals for this research project."
What are some other research examples of Autologous Hematopoietic Stem Cell Transplantation?
"The first study into Autologous Hematopoietic Stem Cell Transplantation was completed in 1993 at the National Institutes of Health Clinical Center. As of now, 1363 trials have been completed with 420 more presently recruiting patients. A large number of these active studies are based out of Saint Louis, Missouri."
Are people with the required medical conditions able to participate in this trial at this time?
"This clinical trial, which was originally posted on 8/29/2017 and most recently edited on 12/22/2021, is currently recruiting candidates."
If I wanted to, could I be a subject in this experiment?
"689 people, ranging in age from 18 to 70 and currently diagnosed with mantle cell lymphoma (mcl) are being enrolled in this study. To be eligible, potential patients must meet the following conditions: They should be considered a willing candidate for auto-HCT by their enrolling physician and have the potential to respond well to treatment; For those who have completed induction therapy, restaging evaluation needs to show that they are in partial (PR) or complete response (CR); Patients who have been registered post-induction with evidence of clinical disease progression are not allowed; Those who have received or completed induction therapy within 60 days prior"
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