brentuximab vedotin for Peripheral T-cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Peripheral T-cell Lymphomabrentuximab vedotin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Peripheral T-cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Approximately 3 years

Approximately 3 years
Duration of response (DOR) per BICR
Month 7
Complete response (CR) rate per BICR
Incidence of adverse events
Incidence of laboratory abnormalities
ORR per BICR per modified Lugano criteria (Cheson 2014)
Objective response rate (ORR) per blinded independent central review (BICR) using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)
Year 3
Overall survival
Progression-free survival (PFS) per BICR

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

CHOP
48%Peripheral sensory neuropathy
42%Constipation
40%Nausea
36%Neutropenia
35%Fatigue
33%Pyrexia
30%Hypertension
28%Night sweats
25%Alopecia
24%Diarrhoea
22%Anaemia
22%Insomnia
21%Decreased appetite
19%Weight decreased
19%Back pain
19%Cough
16%Headache
16%Vomiting
16%Oedema peripheral
15%Dyspnoea
12%Stomatitis
12%Febrile neutropenia
11%Hypokalaemia
11%Dizziness
10%Abdominal pain
9%Rash
9%Arthralgia
9%Asthenia
9%Pain in extremity
9%Myalgia
8%Peripheral motor neuropathy
8%Paraesthesia
8%Oropharyngeal pain
8%Dry skin
7%Gastrooesophageal reflux disease
7%Dysgeusia
7%Depression
7%Pruritus
6%Leukopenia
6%Anxiety
6%Mucosal inflammation
6%Thrombocytopenia
6%Hyperlipidaemia
6%Diabetes mellitus
6%Benign prostatic hyperplasia
6%Hypotension
5%Upper respiratory tract infection
5%Malaise
5%Nasopharyngitis
5%Hypothyroidism
5%Anaplastic large cell lymphoma T- and null-cell types
5%Haemorrhoids
5%Dyspepsia
5%Hypercholesterolaemia
5%Bone pain
4%Urinary tract infection
4%Neck pain
4%Hyperuricaemia
4%Chest pain
4%Abdominal pain upper
4%Hyperglycaemia
3%Pulmonary embolism
2%Sepsis
1%Tachycardia
1%Escherichia sepsis
1%Septic shock
1%Metastases to central nervous system
1%Respiratory failure
1%Dehydration
1%Staphylococcal infection
1%Neutropenic sepsis
1%Skin infection
1%Pneumonia
1%Deep vein thrombosis
1%Multiple organ dysfunction syndrome
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT01777152) in the CHOP ARM group. Side effects include: Peripheral sensory neuropathy with 48%, Constipation with 42%, Nausea with 40%, Neutropenia with 36%, Fatigue with 35%.

Trial Design

2 Treatment Groups

CD30-positive Cohort
1 of 2
CD30-negative Cohort
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: brentuximab vedotin · No Placebo Group · Phase 2

CD30-positive CohortExperimental Group · 4 Interventions: prednisone, cyclophosphamide, doxorubicin, brentuximab vedotin · Intervention Types: Drug, Drug, Drug, Drug
CD30-negative CohortExperimental Group · 4 Interventions: prednisone, cyclophosphamide, doxorubicin, brentuximab vedotin · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Brentuximab vedotin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 3 years

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
185 Previous Clinical Trials
61,499 Total Patients Enrolled
2 Trials studying Peripheral T-cell Lymphoma
417 Patients Enrolled for Peripheral T-cell Lymphoma
Scott Knowles, MD, PhDStudy DirectorSeagen Inc.
1 Previous Clinical Trials
140 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
, are eligible People who have recently been diagnosed with a specific kind of lymphoma called PTCL are eligible for this study
Adult T-cell leukemia is a rare type of cancer that affects cells in the lymph system
PTCL-NOS is a medical term used to describe a medical condition that is not otherwise specified.
is a rare type of T-cell lymphoma
is a rare type of T-cell lymphoma
You have indolent T-cell lymphoproliferative disorder (T-LPD) of the GI tract.
A type of lymphoma that affects the nodes and that has a T-follicular helper (TFH) phenotype.
You have a monomorphic epitheliotropic intestinal T-cell lymphoma.