Clinical trial · Interventional
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
NCT00049595CI-TRIAL-00093111completedPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.
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 (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVD regimen | Drug | — | UNRESOLVED |
| BEACOPP regimen | Drug | — | UNRESOLVED |
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ABVD
- description
- 8 cycles of ABVD
- interventionNames
- Biological: bleomycin sulfate
- Drug: ABVD regimen
- Drug: dacarbazine
- Drug: doxorubicin hydrochloride
- Drug: vinblastine sulfate
- type
- EXPERIMENTAL
- label
- BEACOPP
- description
- 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
- interventionNames
- Biological: bleomycin sulfate
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: BEACOPP regimen
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: prednisone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * No lymphocyte predominant, nodular type (nodular paragranuloma) * Clinical stage III or IV disease * At least 1 bidimensionally measurable target lesion or extranodal lesion * International Prognostic Score of at least 3 PATIENT CHARACTERISTICS: Age * 16 to 60 Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * No prior uncontrolled hepatitis B viral infection * Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma) Renal * Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma) Cardiovascular * No severe cardiac disease that would limit normal life expectancy or preclude study * LVEF at least 50% Pulmonary * No severe pulmonary disease that would limit normal life expectancy or preclude study * Respiratory function at least 30% Other * HIV negative * HTLV1 negative * No severe active infection * No severe neurological or metabolic disease that would limit normal life expectancy or preclude study * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix * No psychological, familial, sociological, or geographical condition that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * No prior therapy for Hodgkin's lymphoma
References
Publications (1)
- DERIVEDCarde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score >/= 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25. PMID 27114593