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Hodgkin LymphomaPhase 2NCT06201507

BV-AVD-R Treatment Children Hodgkin's Lymphoma

A Phase 2 study testing Brentuximab vedotin, Rituximab and Doxorubicin in people with Hodgkin Lymphoma, run by Beijing Children's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to use modified Brentuximab Vedotin+doxorubicin+vinblastine+dacarbazine+Rituximab(BV-AVD-R) regimen in Chinese Classical Hodgkin's Lymphoma(HL) children. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Brentuximab vedotin, Rituximab and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
1 Oct 2022to 31 Dec 2025
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age ≤ 18 years old, regardless of gender;
  • According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive;
  • Newly diagnosed classic Hodgkin's lymphoma: all stages
  • The main organs function normally and meet the following definitions:
  • Blood routine examination: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 75 x 109/L, hemoglobin count ≥ 80 g/dL; Liver and kidney function: AST and ALT ≤ 2.0 upper limit of normal values; Bilirubin ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60 mL/min; 5) Functional status
  • For patients aged 1-16, the Lansky score is ≥ 60 points.
Show all 10Show fewer
  • For patients over 16 years old, the Karnofsky score is ≥ 60 points. 6) Previous treatment
  • Except for emergency mediastinal irradiation (<1000cGy) due to superior vena cava (SVC) syndrome, Hodgkin's lymphoma guidance treatment was not allowed before.
  • 8) Informed consent
  • Patients or their legally authorized guardians must have a thorough understanding of their illness and the nature of the study (including foreseeable risks and possible adverse reactions), and must sign an informed consent form.

Who cannot join

  • Karnofsky<60% or Lansky<60% for individuals under 16 years old.
  • Children with Hodgkin's lymphoma who have received other chemical and radiation treatments.
  • Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Duan Yanlong

    Beijing

Other trials in China

About this study

Official title: Efficacy and Safety of Modified BV-AVD-R Regimen in Chinese Children With Previously Untreated Intermediate- and High-risk Classical Hodgkin's Lymphoma: an Open Label, Non-randomized, Single-arm, Phase 2 Study From Single Center

The goal of this clinical trial is to use modified Brentuximab Vedotin+doxorubicin+vinblastine+dacarbazine+Rituximab(BV-AVD-R) regimen in Chinese Classical Hodgkin's Lymphoma(HL) children. The main questions it aims to answer are:

  • [Overall Response Rate(ORR) :Complete Response(CR)+Partial Response(PR)]
  • [progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.] Participants will be given modified BV-AVD-R regimen according to rapid early responders (RER) or slow early responders (SER) after 2 cycles.
Read the detailed description

This study is a prospective study with period from October 2022 to December 2024, and planned to enroll 44 children with newly diagnosed intermediate- and high-risk classical HL. All patients will undergo Positron Emission Tomography(PET)/Computed Tomography(CT) at the time of initial diagnosis and after 2 cycles of modified BV+R+AVD regimen to determine early response. Rapid early responders (RER) defined as CR after 2 cycles of therapy. Slow early responders (SER) defined as no CR (partial response (PR) or stable disease) after 2 cycles of therapy. Intermediate-risk patients were stage IA bulk/E, IB, IIA bulk/E, IIB, and IIIA. High-risk patients were stage IIB bulk/E, IIIA bulk/E, IIIB, and IVA/B.

The primary endpoints include ORR (CR+PR) and adverse events. The secondary endpoints include progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.

Being tested
Brentuximab vedotin, Rituximab, Doxorubicin, Vincristine, Dacarbazine
Keywords
CD30, Brentuximab vedotin, Children, Hodgkin lymphoma, Efficacy, Safety
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab vedotinDrug

    Also called Adcetris

    Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)

  • RituximabDrug

    Also called Rituxan

    Days: 2 and 16 Dose: 375 mg/m2/dose.

  • DoxorubicinDrug

    Also called Doxil, Adriamycin

    Days: 1 and 15 Dose: 25 mg/m2/dose.

  • VincristineDrug

    Also called Oncovin

    1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).

  • DacarbazineDrug

    Also called DTIC

    375 mg/m2 will be administered on days 1 and 15

Study groups in NCT06201507
Study groupRoleWhat they receive
Intermediate RiskExperimentalIntermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
Receives: Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Dacarbazine
High RiskExperimentalHigh Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
Receives: Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate(ORR)

    disease evaluations will be performed by PET-CT at the end of randomized regimen

    Measured: Baseline up to end of randomized regimen (approximately 1 year)

Secondary outcomes (1)

  1. Progression-free survival(PFS)

    disease evaluations will be performed at at 6 months and 1 year after the end of treatment

    Measured: 6 month and 1 year after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06201507
Sponsor's protocol ID
[2022]-E-233-Y
Status last verified
Jan 2024
First submitted
30 Oct 2023
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab vedotin, Rituximab and Doxorubicin in people with Hodgkin Lymphoma, run by Beijing Children's Hospital at 1 site in China.

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 10 inclusion and 3 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 12 Jan 2024. 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 China. 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?

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?

Overall Response Rate(ORR) (time frame: Baseline up to end of randomized regimen (approximately 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06201507.

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 12 Jan 2024.

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