Lymphoma, T-Cell, PeripheralPhase 2NCT05006664
Brentuximab Vedotin in Combination With CHEP in Patient With PTCL
A Phase 2 study testing Adcetris 50 MG Injection, Endoxan and Doxorubicin in people with Lymphoma, T-Cell, Peripheral, run by Czech Lymphoma Study Group at 7 sites in Czechia.
Trial summary
A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- Adcetris 50 MG Injection, Endoxan and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesCzechia
- Study dates
- Oct 2021to Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Written informed consent
- Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible:
- Systemic anaplastic large cell lymphoma (ALCL) ALK+ with age-adjusted international prognostic index (aaIPI) ≥1
- Systemic anaplastic large cell lymphoma (ALCL) ALK-
- Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
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- Angioimmunoblastic T-cell lymphoma (AITL)
- Adult T-cell leukaemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukaemia virus 1)
- Enteropathy-associated T-cell lymphoma (EATL)
- Hepatosplenic T-cell lymphoma
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
- Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
- Follicular T-cell lymphoma
- Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
- Positive CD30 expression by local pathology assessment.
- Patients must have at least one measurable disease site. The lesion must be fluorodeoxyglucose (FDG)-avid by PET and must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm by CT, as assessed by the site radiologist.
- Eastern Cooperative Oncology Group (ECOG, Appendix B) performance status of 0 to 1
- Patient must be autologous stem cell transplant (ASCT)-eligible
- Patient must be appropriate candidate for treatment with anthracyclines
- Patient must have the following laboratory criteria at screening:
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (unless secondary to bone marrow involvement by PTCL)
- Platelet count ≥ 50 x 109/L (unless secondary to bone marrow involvement by PTCL)
- Total serum bilirubin < 1.5 × upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤3 × ULN
- Alanine transaminase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 × ULN, or <5 × ULN in cases of documented liver involvement by lymphoma
- Serum creatinine clearance must be >40 mL/minute/1.73m2 either measured or calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 1976, Appendix A) and serum creatinine must be <175 µmol/L.
- Females of childbearing potential (FCBP) must not be pregnant or breastfeeding and must agree to use at least two effective contraception method during the study and for 6 months following the last dose of treatment.
- Male participants must: Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of treatment.
- In the opinion of investigator, the patient must:
- be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations
- not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative
Who cannot join
- Current diagnosis of any following lymphomas:
- Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumour spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible)
- Mycosis fungoides (MF), including transformed MF
- PTCL CD30-negative
- History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non- melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- History of progressive multifocal leukoencephalopathy (PML).
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- Known central nervous system (CNS) lymphoma involvement
- Prior treatment with brentuximab vedotin.
- Baseline peripheral neuropathy ≥Grade 2 (per the NCI CTCAE, Version 5.0)
- Left ventricular ejection fraction (LVEF) of < 45% or history of myocardial infarction ≤6 months, or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias) or prior treatment with anthracyclines.
- Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- History of hypersensitivity to any component of CHEP, to compounds of similar biological or chemical composition as brentuximab vedotin, and/or the excipients contained in any of the drug formulations of study treatment.
- Females who are pregnant or breastfeeding
- Planned CNS prophylaxis with intravenous high-dose methotrexate.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Czechia7 sites
University Hospital Brno
Brno, 625 00
University Hospital Hradec Králové
Hradec Králové, 500 05
University Hospital Olomouc
Olomouc, 775 20
University Hospital Ostrava
Ostrava, 70852
University Hospital Plzeň
Pilsen, 323 00
University Hospital Kralovske Vinohrady
Prague, 100 00
Charles University General Hospital
Prague, 128 08
About this study
Official title: A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)
A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)
Read the detailed description
Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson B et al. 2014) and will be based on investigator assessment Efficacy will be evaluated in terms of CR rate, ORR, PFS, EFS, OS.
The safety and tolerability of study treatment will be evaluated by means of AE reports (nature, severity, frequency, causality), performance status, physical examinations, ECG and laboratory safety evaluations.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- Adcetris 50 MG Injection, Endoxan, Doxorubicin, Etoposide, Prednisone tablet
- Keywords
- CD30-expressing, brentuximab vedotin, CHEP
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adcetris 50 MG InjectionDrug
Also called Brentuximab Vedotin
Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.
EndoxanDrug
Also called Cyclophosphamide
Treatment by study drug Cyclophosphamide (Endoxan) in combination.
DoxorubicinDrug
Also called Doxorubicin Ebewe, Doxorubicin Medac
Treatment by study drug Doxorubicin in combination.
EtoposideDrug
Also called Etoposide ACCORD
Treatment by study drug Etoposide in combination.
Prednisone tabletDrug
Also called Prednison Léčiva
Treatment by study drug Prednisone in combination.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin (Adcetris) in Combination with CHEP | Experimental | Single arm, open label, Brentuximab Vedotin (Adcetris) in Combination with CHEP Receives: Drug: Adcetris 50 MG Injection; Drug: Endoxan; Drug: Doxorubicin; Drug: Etoposide; Drug: Prednisone tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-negative complete response (CR) rate at the end of treatment
Complete response
Measured: 6m months
Secondary outcomes (8)
Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.
Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.
Measured: 38 months
Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.
ype, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.
Measured: 38 months
Progression-free survival (PFS)
PFS is defined as the time from C1D1 to the date of the first clinically or radiologically or histologically/cytologically documented disease progression or death due to any cause. If a patient has not progressed, relapsed, or died as of the clinical cut-off date for final analysis, PFS will be censored on the date of last disease assessment when the patient is known to be alive and progression-free. If no tumour assessments are performed after the baseline visit or all post-baseline tumour assessment results have overall responses of "not evaluable", PFS will be censored on the date of study entry.
Kaplan Meier plots will be used to estimate the distribution of PFS. The PFS probabilities at 12 and 24 months, and the associate 95% CI will be summarized.
Measured: 12 months, 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time from C1D1 until death from any cause and documented by the date of death.
Kaplan Meier plots will be used to estimate the distribution of OS. The OS probabilities at 12 and 24 months, and the associate 95% CI will be summarized for each treatment arm.
Measured: 12months, 24 months,
Event-free survival (EFS)
EFS is defined as the time from C1D1 to the date of the first clinically or radiologically documented disease progression or death due to any cause or start of new anti-lymphoma treatment (pre-planned radiotherapy or pre-planned HDT with ASCT are not counted as an event). If a patient has not progressed, relapsed, or died or started a new anti-lymphoma treatment at the analysis cut-off date, EFS will be censored on the date of last contact.
Kaplan Meier plots will be used to estimate the distribution of EFS. The EFS probabilities at 12 and 24 months, and the associate 95% CI will be summarized.
Measured: 12months, 24 months,
Objective Response Rate (ORR) at the end of treatment
The ORR is defined as the proportion of patients with CR or PR based on the response achieved at the end of treatment.
The ORR along with 95% CI will be presented. The number and percentage of patients with CR and the number of patients with PR will also be presented.
Measured: 38 months
Rate of pre-planned upfront HDT/ASCT
The rate of pre-planned upfront HDT/ASCT is defined as the proportion of patients who underwent the pre-planned HDT/ASCT after end of treatment.
The rate of pre-planned upfront HDT/ASCT along with 95% CI will be presented.
Measured: 38 months
Duration of response (DoR)
Duration of response (DoR) is defined as the time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of patients with the CR or PR assessment at EoT evaluation. For patients achieving a response who have not experienced disease progression, relapse, or died prior to the time of the analysis, the duration of response will be censored on the date of last disease assessment.
Kaplan Meier plots will be used to estimate the distribution of DoR.
Measured: 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm, combination - brentuximab vedotin+cyclophosphamide+doxorubicin+etoposide+prednison
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Lymphoma Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magdaléna Zikmundová, MD, Ph.D., Study director, Subinvestigator, Protocol completation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006664
- Sponsor's protocol ID
- CLSG-PTCL-CHEPA
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)
- ClinicalTrials.gov ID
- NCT05006664
- Acronym / sponsor ID
- CLSG-PTCL-CHEPA
- Conditions
- Lymphoma, T-Cell, Peripheral
- Keywords
- CD30-expressing, brentuximab vedotin, CHEP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Czech Lymphoma Study GroupUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)
Detailed description
Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson B et al. 2014) and will be based on investigator assessment Efficacy will be evaluated in terms of CR rate, ORR, PFS, EFS, OS.
The safety and tolerability of study treatment will be evaluated by means of AE reports (nature, severity, frequency, causality), performance status, physical examinations, ECG and laboratory safety evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm, combination - brentuximab vedotin+cyclophosphamide+doxorubicin+etoposide+prednison
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin (Adcetris) in Combination with CHEP | Experimental | Drug: Adcetris 50 MG Injection, Drug: Endoxan, Drug: Doxorubicin, Drug: Etoposide, Drug: Prednisone tabletSingle arm, open label, Brentuximab Vedotin (Adcetris) in Combination with CHEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Age >18 years
- Written informed consent
- Histologically confirmed diagnosis of CD30-expressing PTCL. The following histological subtypes according to the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification are eligible:
- Positive CD30 expression by local pathology assessment.
- Patients must have at least one measurable disease site. The lesion must be fluorodeoxyglucose (FDG)-avid by PET and must have a greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm by CT, as assessed by the site radiologist.
Key exclusion criteria (15 listed)
- Current diagnosis of any following lymphomas:
- History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non- melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- History of progressive multifocal leukoencephalopathy (PML).
- Known central nervous system (CNS) lymphoma involvement
- Prior treatment with brentuximab vedotin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adcetris 50 MG InjectionAlso: Brentuximab VedotinTreatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP. | Drug | Brentuximab Vedotin (Adcetris) in Combination with CHEP |
| EndoxanAlso: CyclophosphamideTreatment by study drug Cyclophosphamide (Endoxan) in combination. | Drug | Brentuximab Vedotin (Adcetris) in Combination with CHEP |
| DoxorubicinAlso: Doxorubicin Ebewe, Doxorubicin MedacTreatment by study drug Doxorubicin in combination. | Drug | Brentuximab Vedotin (Adcetris) in Combination with CHEP |
| EtoposideAlso: Etoposide ACCORDTreatment by study drug Etoposide in combination. | Drug | Brentuximab Vedotin (Adcetris) in Combination with CHEP |
| Prednisone tabletAlso: Prednison LéčivaTreatment by study drug Prednisone in combination. | Drug | Brentuximab Vedotin (Adcetris) in Combination with CHEP |
Primary outcome
PET-negative complete response (CR) rate at the end of treatment
Time frame: 6m months
Complete response
8 secondary outcomes
Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.
Time frame: 38 months
Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.
Time frame: 38 months
Progression-free survival (PFS)
Time frame: 12 months, 24 months
Overall survival (OS)
Time frame: 12months, 24 months,
Event-free survival (EFS)
Time frame: 12months, 24 months,
Objective Response Rate (ORR) at the end of treatment
Time frame: 38 months
Rate of pre-planned upfront HDT/ASCT
Time frame: 38 months
Duration of response (DoR)
Time frame: 38 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdaléna Zikmundová, MD, Ph.D. study director
Subinvestigator, Protocol completation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adcetris 50 MG Injection, Endoxan and Doxorubicin in people with Lymphoma, T-Cell, Peripheral, run by Czech Lymphoma Study Group at 7 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Trněný, prof. MD (+420 224 962 527, trneny@cesnet.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-negative complete response (CR) rate at the end of treatment (time frame: 6m months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.