Clinical trial · Interventional
Combination Chemotherapy With or Without Rituximab in Treating Participants With Stage III-IV Classic Hodgkin Lymphoma
A Randomized Phase II Study of Rituximab With ABVD Versus Standard ABVD for Patients With Advanced-Stage Classical Hodgkin Lymphoma With Poor Risk Features (IPS Score > 2)
- 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 phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classic Hodgkin Lymphoma | Classic Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lugano Classification Stage III Hodgkin Lymphoma AJCC v8 | — | UNRESOLVED | — |
| Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (rituximab, combination chemotherapy)
- description
- Participants receive rituximab intravenously IV over 7 hours on days 1, 8, 15, and 22 of course 1 and on days 1 and 8 of course 2. Participants also receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine IV over 1 hour on days 1 and 15. Treatment with ABVD repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Bleomycin
- Drug: Dacarbazine
- Drug: Doxorubicin Hydrochloride
- Biological: Rituximab
- Drug: Vinblastine
- type
- ACTIVE_COMPARATOR
- label
- Arm B (combination chemotherapy)
- description
- Participants receive doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine as in Arm A.
- interventionNames
- Drug: Bleomycin
- Drug: Dacarbazine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV * International Prognostic Score of \> 2 (patient must have \> 2 of the following risk features: Male, \>= 45 years of age, stage IV, albumin \< 4, white blood cell count \[WBC\] \>= 15, lymphocytes \< 8% or \< 600, hemoglobin \[Hgb\] \< 10.5) * Must sign a consent form * Absolute neutrophil count (ANC) \>= 1,500/microL * Platelet \> 100,000/microL * Left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition (MUGA) scan or echocardiogram * Serum creatinine \< 2 mg/dl * Serum bilirubin \< 2 mg/dl * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) * Bi-dimensionally measurable disease Exclusion Criteria: * Lymphocyte predominant Hodgkin's lymphoma * Known human immunodeficiency virus (HIV) infection * Pregnant women and women of child bearing age who are not practicing adequate contraception * Prior chemotherapy or radiation therapy * Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma * Active infection requiring treatment with intravenous therapy * Presence of central nervous system (CNS) lymphoma * Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix) * Active hepatitis B or C infection
References
Publications (0)
Data not yet available