Clinical trial · Interventional
OPTmizing Advanced Stage HodgkIn LymphoMa patIentS Therapy
A Phase II, Multicenter, Open Label Study of Treatment Intensification With ACVD and Brentuximab-Vedotin in Advanced-stage Hodgkin Lymphoma Patients With a Positive Interim PET Scan After 2 ABVD Cycles
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multi-center, open-label, phase II clinical trial, aims to assess the effectiveness of the combination ACVD (Adriamycin, Cyclophosphamide, Vinblastine and Dacarbazine) and BV (Brentuximab Vedotin) in PET-2 positive advanced-stage HL patients, in order to improve the overall long-term disease control in the entire cohort of advanced-stage HL.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Hodgkin Lymphoma (Category) | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVD | Drug | — | UNRESOLVED |
| Adriamycin | Drug | — | UNRESOLVED |
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Patients with PET-2 Negative Result
- description
- After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results PET-2 negative patients will be treated with 4 cycles of ACVD (Adriamycin, Cyclophosphamide, Vinblastine And Dacarbazine)
- interventionNames
- Drug: Adriamycin
- Drug: Cyclophosphamide
- Drug: Vinblastine
- Drug: Dacarbazine
- Drug: ABVD
- type
- OTHER
- label
- Patients with PET-2 Positive Result
- description
- After 2 ABVD cycles an interim PET-2 will be performed, and treatment will be adapted according to to PET results PET-2 positive patients will be treated with 4 cycles of ACVD with addition of Brentuximab Vedotin
- interventionNames
- Drug: Adriamycin
- Drug: Cyclophosphamide
- Drug: Vinblastine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria:
* All the following parameters should be met
* Newly diagnosed untreated ,histologically proven CD30 positive classical Hodgkin Lymphoma (cHL)
* Advanced stage (Stage IIB to IVB) as defined by Ann Arbor Staging System (Appendix 1)
* Age ≥ 14, \< 60 years
* ECOG performance status 0-2
* Written informed consent for the trial
* Adequate contraceptive precautions for all patients of childbearing potential
* All prognostic group
Exclusion Criteria:
* Any of the following:
* Pregnant or lactating women.
* Presence of the following:
1. Heart failure with LVEF \<50%
2. Liver enzymes, \>2 ULN not attributed to Hodgkin Lymphoma.
3. Another malignancy that is currently clinically significant or requires active intervention
* Early-stage disease (Stage I- IIA).
* Patients who are already participating to another clinical trial.
* Known history of HIV seropositive status
* ECOG performance status 3-4
* Creatinin clearance \<50 ml/min
* Prior treatment for Hodgkin Lymphoma excluding steroids
* Medical or psychiatric conditions compromising the patient's ability to give informed consent
* Patients with serious active infection
* Pre-existing peripheral neuropathy (grade 2 or more).References
Publications (0)
Data not yet available