Your session is about to expire
← Back to Search
Combination Chemotherapy +/− Bortezomib for Lymphoma
Study Summary
This trial is comparing how well two different combination chemotherapies work in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic 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.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have been recently diagnosed with T-ALL or T-LLy at stage II-IV.I've taken steroids for no more than 5 days in the last week or 14 days in the last month.I have not had chemotherapy for my current T-ALL or T-L-Ly diagnosis before starting treatment on AALL1231.I have received or need 600 cGy of chest radiation for medical reasons.I am between 1 and 31 years old.I have significant nerve damage affecting my senses or movement.I have been diagnosed with T-ALL based on specific markers in my blood or bone marrow.I have been treated with hydroxyurea.I haven't been in other drug trials within the last 14 days, or taken bortezomib in the last 30 days.I haven't taken dexamethasone in the last 28 days, except possibly a single dose for sedation.I have had a spinal fluid test before starting chemotherapy, except for steroids.You have a severe medical or mental health condition that could make it difficult for you to take part in this study.You are allergic to bortezomib, boron, or mannitol.I have seizures that are not controlled by medication.I have been diagnosed with Down syndrome.I am not pregnant and willing to take a pregnancy test if capable of becoming pregnant.
- Group 1: Arm A (combination chemotherapy)
- Group 2: Arm B (combination chemotherapy, bortezomib)
- 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
Are there harmful side effects to Arm B (combination chemotherapy, bortezomib)?
"Arm B, which is a combination chemotherapy treatment involving bortezomib, has been given a 3 for safety. This decision was made by our team at Power because Phase 3 trials have shown some efficacy and multiple rounds of data support the notion that it is safe."
How many individuals are part of this research project?
"This clinical trial is not currently recruiting participants. It was first posted on 9/30/2014 and last updated on 1/26/2022. There are 2972 other trials actively recruiting participants with lymphoma and 2277 trials for Arm B (combination chemotherapy, bortezomib) enrolling patients at this time."
What cancerous growths does Arm B (combination chemotherapy, bortezomib) work best against?
"Arm B (combination chemotherapy, bortezomib) is not only for macular edema. It can also help with pheochromocytomas, eye conditions, and ulcerative colitis."
Is this clinical trial being run in many places across North America?
"Right now, this trial is looking for volunteers from a total of 100 hospitals. The specific locations are Durham, Greenville and Sacramento; however, there are many other options available too. By selecting the location closest to you, participating will be more convenient."
What are the goals that researchers are hoping to achieve with this clinical trial?
"The aim of this trial, which will take place over a period of 3 years, is to improve Event-free Survival (EFS) rates for patients with modified Augmented Berlin-Frankfurt-Munster Backbone cancer. Additionally, the study hopes to observe differences in EFS between those treated with or without bortezomib. Secondary objectives include understanding EFS rates for very high risk (VHR) T-cell lymphoblastic lymphoma patients treated according different intensification blocks – specifically among those who enter remission and those who do not respond to therapy. Three-year EFS will be calculated for all"
What is the age limit for participants in this research project?
"This particular clinical trial is only for patients that are aged 1 to 30 years old. Out of the 1145 trials taking place for patients under 18 and the 4427 trials available for adults over 65, this is one of the few."
Could you please list any other research that has been conducted on Arm B (combination chemotherapy, bortezomib)?
"The first trial for Arm B (combination chemotherapy, bortezomib) was at National Institutes of Health Clinical Center in 1995. 4410 trials have completed since then. There are 2277 studies currently being performed with many taking place in Durham, North carolina."
Is there still room for participants in this research project?
"This specific trial is not currently looking for more participants, as it was last updated over half a year ago. However, there are nearly 3000 other trials actively enrolling patients with lymphoma and almost 2300 trials specifically involving Arm B (combination chemotherapy, bortezomib)."
If I wanted to help out with this research, how could I get involved?
"This study is searching for 847 individuals between the ages of 1 year and 30 who have been diagnosed with lymphoma. Tissue samples must be available for flow cytometry analysis, and patients must meet the following criteria: All patients must be > 1 and < 31 years of age, For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be"
Share this study with friends
Copy Link
Messenger