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Monoclonal Antibodies
Brentuximab + Chemotherapy for T-Cell Lymphoma
Phase 2
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the time from enrollment to death from any cause assessed up to 1 year.
Awards & highlights
Study Summary
This trial is studying brentuximab vedotin and combination chemotherapy as a possible treatment for CD30-positive peripheral T-cell lymphoma.
Who is the study for?
This trial is for patients with CD30-positive peripheral T-cell lymphoma. Participants must have measurable disease, proper liver and kidney function, a certain level of blood cells, and no severe infections or other cancers in remission less than 3 years. Pregnant or breastfeeding women can't join, nor those with HIV or hepatitis B/C. Patients should not have had previous systemic anti-lymphoma treatments except possibly one cycle of specific therapies.Check my eligibility
What is being tested?
The trial tests brentuximab vedotin combined with chemotherapy drugs (cyclophosphamide, doxorubicin, etoposide phosphate, prednisone) against this type of lymphoma. Brentuximab vedotin targets cancer cells by attaching to CD30 and delivering a toxin to kill them while the chemo drugs work to stop cancer growth in various ways.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drug infusion, fatigue, nausea from chemotherapy agents; potential damage to organs like the liver due to toxicity; increased risk of infection; and blood-related issues such as low platelet counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the time from enrollment to death from any cause assessed up to 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the time from enrollment to death from any cause assessed up to 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
Secondary outcome measures
Overall Survival at 1 Year
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CHEP-BV)Experimental Treatment8 Interventions
INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide Phosphate
2011
Completed Phase 2
~160
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Etoposide
2010
Completed Phase 3
~2440
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,412 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,224 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
11 Previous Clinical Trials
1,513 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had progressive multifocal leukoencephalopathy in the past.I have been treated for PTCL with medications, experimental drugs, or radiation.I may have had one round of specific cancer treatments but started the study treatment after 19 days.I have had another type of cancer, but it has been in remission for at least 3 years.I have had skin cancer (not melanoma) or cervical cancer that did not spread.My lymphoma has spread to my brain or spinal cord.I am not pregnant or breastfeeding.I have moderate to severe nerve damage or Charcot-Marie-Tooth disease.I can take care of myself and am up and about more than half of my waking hours.My condition is PTCL-NOS.I have been diagnosed with Angioimmunoblastic T-cell lymphoma.I have been diagnosed with adult T-cell lymphoma/leukemia.My cancer is CD30 positive.My ALCL is ALK-positive with a high risk score and advanced stage.I have been diagnosed with EATL.I do not have HIV, hepatitis B, or active hepatitis C.I have not had a severe infection in the last 2 weeks.My lymphoma is of the T-cell or NK-cell type, as confirmed by testing.My cancer is ALK-negative.I have been diagnosed with hepatosplenic T-cell lymphoma.I agree to use birth control or abstain from sex for 6 months after my last treatment dose.My lymphoma has spread to my bone marrow.My bilirubin levels are within the normal range, or slightly higher if I have liver involvement.My liver enzyme (ALT) levels are within the normal range, or up to 5 times the normal limit if my lymphoma affects my liver.My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.I have not had heart issues, stroke, or heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CHEP-BV)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given clearance for Cyclophosphamide to be used as a medicinal treatment?
"Cyclophosphamide's safety has been documented to a measurable degree, thus it received an evaluation of 2. However, no clinical trials have established the efficacy of this medication yet."
Answered by AI
What existing accounts have been documented regarding the utilization of Cyclophosphamide in clinical trials?
"At present, there are 1451 studies in progress centred around the drug Cyclophosphamide; of these, 319 have reached Phase 3. While Bethesda is a hub for this research, trials can be found at 54325 different sites all over the world."
Answered by AI
How many participants have volunteered for this clinical trial?
"This trial has since ceased its recruitment of patients. Originally posted on May 25th 2017, it was last updated on June 2nd 2022. However, there are still 1774 studies that require individuals with enteropathy-associated T-cell lymphoma and 1451 trials for Cyclophosphamide seeking to enroll new participants."
Answered by AI
Is this research project currently open to enrollment?
"The information on clinicaltrials.gov indicates that the recruitment phase for this trial has been closed since June 2nd, 2022. However, there are 3225 other studies still actively seeking patients at present time."
Answered by AI
What indications are most commonly treated with Cyclophosphamide?
"Cyclophosphamide is a viable treatment option for prostate cancer, colitis ulcerosa, and acute retinal necrosis caused by the varicella-zoster virus."
Answered by AI
How many venues are overseeing this research project?
"At present, 5 different sites are admitting participants into this clinical trial. In addition to Vancouver, Houston and Duarte; 2 further locales have been identified. It would be advantageous for prospective patients to select the nearest location in order to reduce travelling costs."
Answered by AI
Is this a pioneering experiment in its field?
"Presently, 1451 active clinical trials for Cyclophosphamide are being conducted across 81 countries and 3076 cities. Alfacell's 1997 Phase 3 study of 300 patients was the first to utilize this medication. Since then, 2849 further studies have been performed."
Answered by AI
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