Anti-CD30NCT07171827
Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
A study testing Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine and Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine in people with Anti-CD30 and Brentuximab, run by Helwan University at 1 site in Egypt.
Trial summary
This study will be held in the clinical oncology department, Helwan University, and Police Hospital, aiming to compare the efficacy and safety of anti-CD30 (BV) + Doxorubicin, Vinblastine, and Dacarbazine (AVD) versus the standard of care Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as frontline therapy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anti-CD30, Brentuximab, Doxorubicin
- What is being tested?
- Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine and Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Feb 2025
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18- 70 Years.
- Histopathology: confirmed classical Hodgkin Lymphoma according to the current World Health Organization (WHO) classification. CD30 positive by immunohistochemistry.
- Stage III or IV Hodgkin lymphoma (HL) by the Ann Arbor classification system.
- Treatment-naïve.
- Laboratory:
- complete blood count: absolute neutrophil counts (≥1500 per cubic millimeter), platelet counts (≥75,000 per cubic millimeter), and hemoglobin levels (≥8 g per deciliter) (except for patients with involvement of the marrow).
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- liver function test: total bilirubin level <1.5 times the upper limit of normal and alanine aminotransferase or aspartate aminotransferase levels <3 times the upper limit of normal.
- kidney function test: serum creatinine level, <2.0 mg per deciliter or creatinine clearance or calculated creatinine clearance, >40 ml per minute.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Who cannot join
- Histopathology: Nodular lymphocyte predominant Hodgkin lymphoma and non-Hodgkin lymphoma.
- Cerebral/meningeal disease.
- Prior treatment with chemotherapy, radiotherapy, or any immunotherapy within 12 weeks of first study drug dose.
- Known human immunodeficiency virus (HIV) positive, known hepatitis B surface antigen-positive, or known active hepatitis C infection.
- Known organ failure.
- Cardiac: left ventricular ejection fraction < 50%, myocardial infarction within 2 years of randomization or current uncontrolled cardiovascular conditions, including arrhythmias, congestive heart failure, angina, evidence of acute ischemia, or active conduction system abnormalities.
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- Female patients who are breastfeeding or having a positive serum pregnancy test during the randomization period or on day 1 before starting treatment.
- Neurotoxicity, including symptomatic neurologic disease, comprising normal daily activities, any sensory or motor peripheral neuropathy.
- Pulmonary diffusion capacity >25 % lower than predicted value as retrieved by pulmonary function test for each patient before randomization.
- Known hypersensitivity to recombinant proteins, murine proteins, or any component of the included drugs formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Comparing Anti CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
This study will be held in the clinical oncology department, Helwan University, and Police Hospital, aiming to compare the efficacy and safety of anti-CD30 (BV) + Doxorubicin, Vinblastine, and Dacarbazine (AVD) versus the standard of care Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as frontline therapy in patients with advanced classical Hodgkin lymphoma.
Read the detailed description
Hodgkin lymphoma (HL) is a malignancy that typically originates from germinal center B-lymphocytes. It is subdivided into classical type, which represents 95% of histopathology of HL cases (with four histological subtypes, namely, nodular sclerosis, mixed-cellularity, lymphocyte-rich, and lymphocyte-depleted), and nodular lymphocyte-predominant HL.
For patients with newly diagnosed Ann Arbor stage III/IV (advanced stage) HL, 70% are expected to be cured after treatment with Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD), which has been the preferred standard of care in the United States for many years.
The Risk-adapted therapy for advanced-stage Hodgkin lymphoma (RATHL) study assessed de-escalation to Doxorubicin, Vinblastine, and Dacarbazine (AVD) in patients with stage IIB, III, or IV HL (Deauville 1-3) and found that positron emission tomography (PET)-adapted de-escalation to AVD failed to demonstrate noninferiority compared with ABVD.
- Conditions
- Anti-CD30, Brentuximab, Doxorubicin, Vinblastine, Dacarbazine, Frontline
- Being tested
- Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine, Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin + Doxorubicin, Vinblastine, and DacarbazineDrug
Patients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.
Doxorubicin, Bleomycin, Vinblastine, and DacarbazineDrug
Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| BV+AVD group | Experimental | Patients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. Receives: Drug: Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine |
| ABVD group | Experimental | Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. Receives: Drug: Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free Survival was recorded.
Measured: 2 years post-procedure
Secondary outcomes (3)
Overall response rate
Overall Response Rate (ORR) is the percentage of participants who achieved complete remission (CR) or partial remission (PR) at the end of treatment with randomized regimen.
Measured: 30 days after the end of treatment
Overall survival
Overall survival was recorded.
Measured: 2 years post-procedure
Incidence of adverse events
Incidence of adverse events such as toxicity, incidence, severity and type starting after administration of the first dose till 30 days after end of frontline therapy were recorded.
Measured: 30 days after the end of frontline therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Mar 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-CD30Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Nazih Abdel Gawad, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171827
- Sponsor's protocol ID
- 40-2023
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Anti CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07171827
- Acronym / sponsor ID
- 40-2023
- Conditions
- Anti-CD30, Brentuximab, Doxorubicin, Vinblastine, Dacarbazine, Frontline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 15 Sep 2025 (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.
This study will be held in the clinical oncology department, Helwan University, and Police Hospital, aiming to compare the efficacy and safety of anti-CD30 (BV) + Doxorubicin, Vinblastine, and Dacarbazine (AVD) versus the standard of care Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as frontline therapy in patients with advanced classical Hodgkin lymphoma.
Detailed description
Hodgkin lymphoma (HL) is a malignancy that typically originates from germinal center B-lymphocytes. It is subdivided into classical type, which represents 95% of histopathology of HL cases (with four histological subtypes, namely, nodular sclerosis, mixed-cellularity, lymphocyte-rich, and lymphocyte-depleted), and nodular lymphocyte-predominant HL.
For patients with newly diagnosed Ann Arbor stage III/IV (advanced stage) HL, 70% are expected to be cured after treatment with Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD), which has been the preferred standard of care in the United States for many years.
The Risk-adapted therapy for advanced-stage Hodgkin lymphoma (RATHL) study assessed de-escalation to Doxorubicin, Vinblastine, and Dacarbazine (AVD) in patients with stage IIB, III, or IV HL (Deauville 1-3) and found that positron emission tomography (PET)-adapted de-escalation to AVD failed to demonstrate noninferiority compared with ABVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BV+AVD group | Experimental | Drug: Brentuximab Vedotin + Doxorubicin, Vinblastine, and DacarbazinePatients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. |
| ABVD group | Experimental | Drug: Doxorubicin, Bleomycin, Vinblastine, and DacarbazinePatients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18- 70 Years.
- Histopathology: confirmed classical Hodgkin Lymphoma according to the current World Health Organization (WHO) classification. CD30 positive by immunohistochemistry.
- Stage III or IV Hodgkin lymphoma (HL) by the Ann Arbor classification system.
- Treatment-naïve.
- Laboratory:
Key exclusion criteria (10 listed)
- Histopathology: Nodular lymphocyte predominant Hodgkin lymphoma and non-Hodgkin lymphoma.
- Cerebral/meningeal disease.
- Prior treatment with chemotherapy, radiotherapy, or any immunotherapy within 12 weeks of first study drug dose.
- Known human immunodeficiency virus (HIV) positive, known hepatitis B surface antigen-positive, or known active hepatitis C infection.
- Known organ failure.
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 Vedotin + Doxorubicin, Vinblastine, and DacarbazinePatients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. | Drug | BV+AVD group |
| Doxorubicin, Bleomycin, Vinblastine, and DacarbazinePatients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle. | Drug | ABVD group |
Primary outcome
Progression-free survival
Time frame: 2 years post-procedure
Progression-free Survival was recorded.
3 secondary outcomes
Overall response rate
Time frame: 30 days after the end of treatment
Overall survival
Time frame: 2 years post-procedure
Incidence of adverse events
Time frame: 30 days after the end of frontline therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine and Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine in people with Anti-CD30 and Brentuximab, run by Helwan University at 1 site in Egypt.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 years post-procedure). 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 15 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.