Clinical trial · Interventional
Rituximab and ABVD for Hodgkin's Patients
A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
NCT00504504CI-TRIAL-00011238completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Primary Objective: \- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy. ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Bleomycin | Drug | Bleomycin | ALIAS |
| Dacarbazine (DTIC) | Drug | Dacarbazine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + ABVD Chemotherapy
- description
- Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
- interventionNames
- Drug: Rituximab
- Drug: Adriamycin
- Drug: Bleomycin
- Drug: Vinblastine
- Drug: Dacarbazine (DTIC)
Primary outcomes (1)
- measure
- 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
- timeFrame
- Baseline to 5 Years or until disease progression
- description
- Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: 1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD. 2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity). 3. Must have bidimensionally measurable disease. 4. Must sign a consent form. 5. Must be older than 16 years of age. 6. Must have adequate bone marrow reserve (ANC \> 1,000/microL, Platelet \> 100,000/microL 7. Left Ventricular Ejection Fraction (LVEF) \>/= 50% by multigated acquisition (MUGA) scan or echocardiogram. 8. Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl Exclusion Criteria: 1. HIV positive. 2. Pregnant women and women of child bearing age who are not practicing adequate contraception. 3. Prior chemotherapy. 4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
References
Publications (1)
- RESULTYounes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4123-8. doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27. PMID 22371887