Relapsed/Refractory Classical Hodgkin LymphomaPhase 2NCT05243693
Brentuximab Vedotin Plus DHAP in Relapsed or Refractory Hodgkin's Lymphoma
A Phase 2 study testing Brentuximab vedotin in people with Relapsed/Refractory Classical Hodgkin Lymphoma, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment. < Treatment Schedule > 1. Induction phase Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Relapsed/Refractory Classical Hodgkin Lymphoma
- What is being tested?
- Brentuximab vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2022to 31 Mar 2026
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of classical Hodgkin's lymphoma. CD30 has to be positive
- Refractory to the first-line treatment or relapse after the first-line treatment (radiologically confirmed)
- Deauville score 5 as a result of the restaging PET-CT after 2 to 3 cycles of ABVD treatment
- Deauville score 4 to 5 even after the completion of ABVD treatment or radiotherapy and are not candidates for ISRT (involved site radiation therapy)
- Radiologically confirmed relapsed after achieving CR
- At least one measurable lesion(s)
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- nodal lesion longest transverse diameter (LDi) ≥ 1.5 cm
- extranodal lesion LDi ≥ 1.0 cm)
- Age 19 to 70 years
- ECOG PS 0 - 2
- Appropriate organ functions to tolerate the protocol treatment and ASCT Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L Platelets ≥ 75 x 10^9/L Hemoglobin ≥ 8.0 g/dL Serum Creatinine ≤ 1.5 x upper limit normal (ULN) Serum Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3 x ULN Corrected diffusing capacity for carbon monoxide (DLCO) ≥50 percent
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- Written informed consent
Who cannot join
- Non-Hodgkin's lymphoma or nodular lymphocyte predominant Hodgkin's lymphoma
- 2 or more prior lines of treatment (Palliative radiotherapy or high-dose steroid therapy for symptom control are allowed)
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- Confirmed CNS involvement and/or symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- Patients who cannot tolerate high-dose therapy followed by ASCT described in the inclusion criteria 6.
- Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders. For example, i. severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and/or O2 saturation that is 90% or less at rest on room air ii. any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study iii. nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication iv. creatinine clearance < 30 mL/min
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- Known history of any of the following cardiovascular conditions i. Myocardial infarction within 2 years of enrollment ii. New York Heart Association (NYHA) Class III or IV heart failure iii. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities iv. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
- Synchronous or metachronous malignant tumor other than HL within 5 years (except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, carcinoma in situ of the uterine cervix, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).
- Hypersensitivity to the investigational products.
- Peripheral neuropathy ≥ Grade 2
- Pregnant or nursing women
- Human immunodeficiency virus (HIV)-positive
- Active hepatitis B or hepatitis C infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hyeon-Seok Eom
Goyang-si, Gyeonggi-do, 10408
Hyeon-Seok Eom, 0319201505, hseom@ncc.re.kr
Jun-Ho Yi, xuno@daum.net
About this study
Official title: Brentuximab Vedotin Plus Cisplatin, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Hodgkin's Lymphoma Who Are Eligible for Transplant
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
Read more
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days.
- Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy.
- Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study.
- Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy.
Read the detailed description
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days. Study Drug Dosage will be as follows; Brentuximab vedotin: 1.8 mg/kg IV over 30 minutes D1 Cisplatin* 100 mg/m2 + NS 1000 mL CIV over 24 hours D1 Cytarabine* 2.0 g/m2 + 5% DW 250 mL IV over 3 hours twice a day D2 Dexamethasone 40 mg IV or PO D1-4 *If baseline or on treatment creatinine clearance is less than 60 mL/min, 25% dose reduction should strongly be considered (cisplatin 75 mg/m2, cytarabine 1.5 g/m2)
- Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy.
- Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study.
- Each cycle is implemented at an interval of 21 days (± 3 days).
- Consolidation phase
- ASCT is performed in accordance with a protocol based on the relevant site's policy.
- Conditioning regimen will be determined by the attending physician. For example, BEAM, BuCyEtopo, BeEAM (Bendamustine+EAM), etc.
- Other conservative managements will be carried out according to the policy of participating site
< Follow-Up Schedule >
- Patients will be recruited up to 3 years from the start date of this study.
- Primary analysis and reporting will be carried out at the completion of ASCT of the last patient.
- PFS and OS will be followed up for up to 2 years from the completion of ASCT of the last patient. Final analysis will be reported at this point.
- After completion of ASCT, a patient will be followed up at an interval of 3 months for 2 years
- Being tested
- Brentuximab vedotin
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab vedotinDrug
Also called Adcetris
3 cycles of Brentuximab vedotin and DHAP
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin and DHAP | Experimental | A clinical study of safety and efficacy of treatment with Brentuximab vedotin and DHAP in patients with relapsed/refractory Hodgkin lymphoma Receives: Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Tumor response is evaluated following 3 cycles (each cycle is 21 days) of BV + DHAP induction therapy
Measured: up to 3 months
Secondary outcomes (4)
Progression free survival
PFS after BV + DHAP induction treatment \& ASCT
Measured: up to 24 months
Overall survival
PFS after BV + DHAP induction treatment \& ASCT
Measured: up to 24 months
Overall response rate
Tumor response is evaluated following 3 cycles (each cycle is 21 days) of BV+ DHAP induction therapy
Measured: up to 3 months
Safety profiles
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 5.0
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study startMar 2022 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Classical Hodgkin LymphomaStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hyeon-Seok Eom, MD, PhD, National Cancer Center, Korea
- Investigators
- Hyeon-Seok Eom, MD, PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243693
- Sponsor's protocol ID
- NCC2020-0293
- Status last verified
- Feb 2022
- First submitted
- 2 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brentuximab Vedotin Plus Cisplatin, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Hodgkin's Lymphoma Who Are Eligible for Transplant
- ClinicalTrials.gov ID
- NCT05243693
- Acronym / sponsor ID
- NCC2020-0293
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2022 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 17 Feb 2022 (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.
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days.
- Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy.
- Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study.
- Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy.
Detailed description
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days. Study Drug Dosage will be as follows; Brentuximab vedotin: 1.8 mg/kg IV over 30 minutes D1 Cisplatin* 100 mg/m2 + NS 1000 mL CIV over 24 hours D1 Cytarabine* 2.0 g/m2 + 5% DW 250 mL IV over 3 hours twice a day D2 Dexamethasone 40 mg IV or PO D1-4 *If baseline or on treatment creatinine clearance is less than 60 mL/min, 25% dose reduction should strongly be considered (cisplatin 75 mg/m2, cytarabine 1.5 g/m2)
- Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy.
- Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study.
- Each cycle is implemented at an interval of 21 days (± 3 days).
- Consolidation phase
- ASCT is performed in accordance with a protocol based on the relevant site's policy.
- Conditioning regimen will be determined by the attending physician. For example, BEAM, BuCyEtopo, BeEAM (Bendamustine+EAM), etc.
- Other conservative managements will be carried out according to the policy of participating site
< Follow-Up Schedule >
- Patients will be recruited up to 3 years from the start date of this study.
- Primary analysis and reporting will be carried out at the completion of ASCT of the last patient.
- PFS and OS will be followed up for up to 2 years from the completion of ASCT of the last patient. Final analysis will be reported at this point.
- After completion of ASCT, a patient will be followed up at an interval of 3 months for 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin and DHAP | Experimental | Drug: Brentuximab vedotinA clinical study of safety and efficacy of treatment with Brentuximab vedotin and DHAP in patients with relapsed/refractory Hodgkin lymphoma |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed diagnosis of classical Hodgkin's lymphoma. CD30 has to be positive
- Refractory to the first-line treatment or relapse after the first-line treatment (radiologically confirmed)
- At least one measurable lesion(s)
- Age 19 to 70 years
- ECOG PS 0 - 2
Key exclusion criteria (13 listed)
- Non-Hodgkin's lymphoma or nodular lymphocyte predominant Hodgkin's lymphoma
- 2 or more prior lines of treatment (Palliative radiotherapy or high-dose steroid therapy for symptom control are allowed)
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- Confirmed CNS involvement and/or symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- Patients who cannot tolerate high-dose therapy followed by ASCT described in the inclusion criteria 6.
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 |
|---|---|---|
| Brentuximab vedotinAlso: Adcetris3 cycles of Brentuximab vedotin and DHAP | Drug | Brentuximab vedotin and DHAP |
Primary outcome
Complete response rate
Time frame: up to 3 months
Tumor response is evaluated following 3 cycles (each cycle is 21 days) of BV + DHAP induction therapy
4 secondary outcomes
Progression free survival
Time frame: up to 24 months
Overall survival
Time frame: up to 24 months
Overall response rate
Time frame: up to 3 months
Safety profiles
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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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.
Hyeon-Seok Eom, MD, PhD principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brentuximab vedotin in people with Relapsed/Refractory Classical Hodgkin Lymphoma, run by National Cancer Center, Korea at 1 site in South Korea.
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 14 inclusion and 13 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 Hyeon-Seok Eom, MD, PhD (+82-31-920-2402, hseom@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: up to 3 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 17 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.