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Monoclonal Antibodies
Brentuximab Vedotin + CHP for T-Cell Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist
Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights
Study Summary
This trial will study the effects of brentuximab vedotin when used with CHP to treat PTCL. It will also study any side effects that occur when the two drugs are used together.
Who is the study for?
This trial is for adults with specific types of peripheral T-cell lymphoma (PTCL) that express less than 10% CD30. Eligible participants include those newly diagnosed with PTCL, excluding systemic anaplastic large cell lymphoma, and have a performance status allowing daily activity. People who've had certain prior cancer treatments or have severe pre-existing conditions are excluded.Check my eligibility
What is being tested?
The study tests brentuximab vedotin combined with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) in treating PTCL. It aims to determine the effectiveness and side effects of this combination therapy compared to standard treatments for patients whose tumors show low CD30 expression.See study design
What are the potential side effects?
Potential side effects from brentuximab vedotin and CHP may include nerve damage, immune system reactions, blood disorders, heart issues due to doxorubicin use, infection risks from lowered white blood cells count, nausea from chemotherapy drugs and general fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show active cancer that's at least 1.5 cm big.
Select...
I have a slow-growing T-cell lymphoma in my digestive system.
Select...
I have been diagnosed with hepatosplenic T-cell lymphoma.
Select...
My lymphoma is a specific type called TFH.
Select...
My cancer shows low CD30 levels in the biopsy.
Select...
I have been diagnosed with a specific type of intestinal lymphoma.
Select...
I have acute or lymphoma-type adult T-cell leukemia/lymphoma and am HTLV-1 positive.
Select...
I have been diagnosed with EATL.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been diagnosed with follicular T-cell lymphoma.
Select...
I have been newly diagnosed with PTCL, not including sALCL.
Select...
My condition is PTCL-NOS.
Select...
I have been diagnosed with Angioimmunoblastic T-cell lymphoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) per blinded independent central review (BICR) using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)
Secondary outcome measures
Complete response (CR) rate per BICR
Duration of response (DOR) per BICR
Incidence of adverse events
+4 moreSide effects data
From 2020 Phase 3 trial • 452 Patients • NCT0177715251%
Nausea
50%
Peripheral sensory neuropathy
44%
Constipation
42%
Diarrhoea
39%
Neutropenia
39%
Pyrexia
37%
Fatigue
32%
Hypertension
29%
Anaemia
27%
Vomiting
26%
Alopecia
24%
Weight decreased
24%
Decreased appetite
23%
Insomnia
21%
Night sweats
20%
Back pain
18%
Oedema peripheral
17%
Dyspnoea
17%
Headache
17%
Cough
16%
Asthenia
14%
Dizziness
14%
Febrile neutropenia
14%
Arthralgia
13%
Stomatitis
13%
Hypokalaemia
13%
Anxiety
12%
Myalgia
12%
Rash
12%
Abdominal pain
10%
Gastrooesophageal reflux disease
10%
Pruritus
10%
Pain in extremity
10%
Abdominal pain upper
9%
Thrombocytopenia
9%
Oropharyngeal pain
8%
Upper respiratory tract infection
8%
Leukopenia
8%
Dyspepsia
7%
Bone pain
7%
Mucosal inflammation
7%
Depression
7%
Hypotension
6%
Dysgeusia
6%
Chest pain
6%
Diabetes mellitus
6%
Paraesthesia
5%
Neck pain
5%
Hyperglycaemia
5%
Hypothyroidism
5%
Urinary tract infection
5%
Alanine aminotransferase increased
5%
Hyperuricaemia
5%
Pneumonia
4%
Nasopharyngitis
4%
Haemorrhoids
4%
Hypercholesterolaemia
4%
Dry skin
4%
Hyperlipidaemia
4%
Malaise
4%
Benign prostatic hyperplasia
4%
Peripheral motor neuropathy
2%
Pneumonitis
2%
Sepsis
1%
Pulmonary embolism
1%
Cellulitis
1%
Pneumocystis jirovecii pneumonia
1%
Respiratory failure
1%
Neutropenic infection
1%
Clostridium difficile colitis
1%
Cutaneous T-cell lymphoma
1%
Acute kidney injury
1%
Deep vein thrombosis
1%
Tumour lysis syndrome
1%
Dehydration
1%
Device related infection
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
A+CHP
CHOP
A+CHP Subgroup
Trial Design
2Treatment groups
Experimental Treatment
Group I: CD30-positive CohortExperimental Treatment4 Interventions
Participants with CD30 expression level ≥1% to < 10%
Group II: CD30-negative CohortExperimental Treatment4 Interventions
Participants with CD30 expression level < 1%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
doxorubicin
2005
Completed Phase 3
~9130
prednisone
1999
Completed Phase 3
~10920
brentuximab vedotin
2010
Completed Phase 3
~1880
cyclophosphamide
1994
Completed Phase 3
~8140
Find a Location
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
69,075 Total Patients Enrolled
Robert Sims, MDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
356 Total Patients Enrolled
Scott Knowles, MD, PhDStudy DirectorSeagen Inc.
2 Previous Clinical Trials
964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show active cancer that's at least 1.5 cm big.I have a slow-growing T-cell lymphoma in my digestive system.I have been diagnosed with hepatosplenic T-cell lymphoma.I have been treated with brentuximab vedotin or doxorubicin.My lymphoma is a specific type called TFH.My heart function is below normal, or I have had heart issues or a heart attack in the last 6 months.I have had cancer before, but it's been in remission for over 3 years or was a type with low risk of spreading.My cancer shows low CD30 levels in the biopsy.I have had progressive multifocal leukoencephalopathy in the past.I haven't had a severe infection in the last 2 weeks.I have acute or lymphoma-type adult T-cell leukemia/lymphoma and am HTLV-1 positive.I have been diagnosed with a specific type of intestinal lymphoma.My cancer type is eligible for the study.I have been diagnosed with anaplastic large cell lymphoma.I have been diagnosed with EATL.I do not have severe nerve damage or Charcot-Marie-Tooth disease.I can take care of myself but might not be able to do heavy physical work.My cancer has spread to my brain or its coverings.I have a type of skin lymphoma.I have been diagnosed with follicular T-cell lymphoma.I have been newly diagnosed with PTCL, not including sALCL.My condition is PTCL-NOS.I have been diagnosed with Angioimmunoblastic T-cell lymphoma.I have a current diagnosis.I have been diagnosed with mycosis fungoides or its advanced form.
Research Study Groups:
This trial has the following groups:- Group 1: CD30-positive Cohort
- Group 2: CD30-negative Cohort
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.
How many research facilities are currently participating in this trial?
"19 different medical centres are currently running this trial. These facilities can be found in Aurora, Cleveland and Knoxville, among other cities. It is recommended that participants find the closest location to reduce travel needs associated with their participation."
Answered by AI
Has brentuximab vedotin been given the green light by the FDA?
"Brentuximab vedotin has been awarded a safety rating of 2, since Phase 2 trials have provided some evidence that the drug is safe but not yet effective."
Answered by AI
Does this trial bring anything new to the table in terms of research?
"Currently, 1180 clinical trials involving brentuximab vedotin are taking place in 73 countries and 2813 cities. The inaugural study was sponsored by Alfacell in 1997, with 300 patients participating up until the Phase 3 approval stage. Since then, 1,834 studies have been concluded."
Answered by AI
What condition is brentuximab vedotin primarily utilized to treat?
"Brentuximab vedotin has been known to effectively treat lung cancer, thyroiditis, and the rare childhood nb (neuroblastoma)."
Answered by AI
What evidence exists for the efficacy of brentuximab vedotin in treating various ailments?
"In 1997, Spectrum Health Hospital - Butterworth Campus was the first to research brentuximab vedotin. Since then, 1834 clinical trials have been concluded and 1180 are still active; many of these studies're taking place in Aurora, Colorado."
Answered by AI
Are there any vacant enrolment slots in this experiment yet?
"Affirmative. According to the information supplied on clinicaltrials.gov, this research project is currently hunting for participants; it was first posted on November 12th 2020 and has been recently modified as of November 11th 2022. The study requires 80 people from 19 different locations."
Answered by AI
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