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Ibrutinib + Stem Cell Transplant for Lymphoma
Study Summary
This trial is studying whether adding ibrutinib to chemotherapy before and after stem cell transplant helps the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
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?
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- I am not on high doses of steroids, or can stop them 14 days before treatment.I am not using HIV protease inhibitors for my HIV treatment.My lymphoma has not affected my brain or spinal cord, or if it did, I've been in remission for over 3 months.I have not had a stroke or brain bleed in the last 6 months.I can take care of myself and am up and about more than half of my waking hours.I am not taking Zidovudine.I can provide tissue samples from my diagnosis for review.I am approved for high-dose chemotherapy and stem cell transplant.My heart functions well during normal activities and I'm over 60 with an LVEF of 40% or more.My condition worsened or didn't respond to previous chemotherapy that included anthracyclines.I am not pregnant or nursing and, if capable of bearing children, have a recent negative pregnancy test.I am using or willing to use effective birth control during and for one month after the study.I don't use strong medication that affects liver enzyme levels regularly.I am HIV positive without AIDS, not on certain HIV meds, and my long-term survival prospects are good.I have a bleeding disorder.An HIV expert believes I would live long if I didn't have lymphoma.I have had up to 3 treatments for my large cell cancer, excluding certain antibody and radiotherapy treatments.I haven't had major surgery in the last week or minor surgery in the last 3 days.I have hepatitis B or C but my PCR test for the virus is negative.I have never had AIDS or related conditions, except for low CD4+ T-cell count or B-cell lymphoma.I am not taking HIV medication that includes a booster like cobicistat.I have used ibrutinib before, but my disease did not worsen on it.I do not have multi-drug resistant HIV.My cancer responded to the most recent chemotherapy.My tests show early signs of a bone marrow disorder before starting treatment.I have not taken warfarin or similar drugs in the last 28 days.I have significant liver problems (Child-Pugh class B or C).My lung function, measured by FEV1, is at least 40% of the expected value.My lymphoma is confirmed as non-GCB diffuse large B-cell type.My kidney function, measured by creatinine levels or clearance, is within the required range.I am 18 years old or older.
- Group 1: Arm I (ibrutinib, chemotherapy, autoHCT)
- Group 2: Arm II (placebo, chemotherapy, autoHCT)
- 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
What is the FDA's opinion on Autologous Hematopoietic Stem Cell Transplantation?
"Autologous Hematopoietic Stem Cell Transplantation is considered safe, as it has received a score of 3."
What are some precedents for this type of blood-based stem cell therapy?
"City of Hope Comprehensive Cancer Center first studied Autologous Hematopoietic Stem Cell Transplantation in 1997. So far, 2255 clinical trials have completed with 1331 still active. Many of these studies are based out of Clackamas, Oregon."
Are there any current vacancies in this trial for new participants?
"That is correct, the online clinical database has this study listed as 'seeking participants'. The trial was created on 7/6/2016 and updated for the last time on 11/11/2022. They are looking for 302 individuals from 100 different locations to take part in the study."
How many people are being given the opportunity to participate in this clinical trial?
"That is correct. The trial, which was originally posted on July 6th 2016 and updated November 11th 2020, is still recruiting patients at 100 sites across the United States of America. They are looking for a total of 302 participants."
What are the most frequent diagnoses that Autologous Hematopoietic Stem Cell Transplantation is used to treat?
"Autologous Hematopoietic Stem Cell Transplantation is a standard treatment for various lung cancers, as well as other diseases such as small cell lung cancer (sclc), multiple sclerosis, leukemia, myelocytic, and acute."
In how many different settings is this experiment being conducted today?
"There are 100 medical centres enrolling patients for this trial, with locations in Clackamas, Hazleton and Norton Shores. If you wish to minimize travel time and distance, please select the nearest site to your location."
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