Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Drug combinations described in this section:

• ABVD: doxorubicin plus bleomycin plus vinblastine plus dacarbazine.
• MOPP: mechlorethamine plus vincristine plus procarbazine plus prednisone.
• MOPP/ABV hybrid: mechlorethamine plus vincristine plus procarbazine plus prednisone/doxorubicin plus bleomycin plus vinblastine.
• Stanford V: doxorubicin plus vinblastine plus mechlorethamine plus etoposide plus vincristine plus bleomycin plus prednisone.
• MOPPEBVCAD: mechlorethamine plus vincristine plus procarbazine plus prednisone plus epidoxorubicin plus bleomycin plus vinblastine plus lomustine plus doxorubicin plus vindesine.

Patients are designated as having advanced favorable Hodgkin lymphoma (HL) if they have clinical stage III or stage IV disease and three or fewer risk factors on the International Prognostic Index for HL, which corresponds to a freedom-from-progression at greater than 60% at 5 years with combination chemotherapy.[1]

ABVD therapy for 6 to 8 months is as effective as 12 months of MOPP alternating with ABVD, and both are superior to MOPP alone in terms of failure-free survival (FFS) (50% vs. 36% with a 14-year median follow-up; P = .03).[2,3][Level of evidence: 1iiA] The Intergroup trial comparing ABVD with MOPP/ABV hybrid showed equivalent efficacy in FFS and overall survival (OS), but increased toxic effects in the hybrid arm, especially from second malignancies.[4][Level of evidence: 1iiA] A prospective randomized study, from the Medical Research Council (MRC) (MRC-UKLG-LY09), of 807 patients compared ABVD with two multidrug regimens also incorporating etoposide, chlorambucil, vincristine, and procarbazine. With 52 months' median follow-up, the 3-year event-free survival was 75% (confidence interval [CI], 71%–79%) for all three regimens, and 88% to 90% OS (CI, 84%–93%) for all three regimens, but there were significantly fewer toxic effects with ABVD.[5][Level of evidence: 1iiA] Stanford V is an alternative drug combination currently under clinical evaluation with the Eastern Cooperative Oncology Group (ECOG) (ECOG-2496).[6] A prospective randomized trial of 355 patients compared Stanford V to ABVD and a variation of MOPP/ABV (MOPPEBVCAD).[7] With a median follow-up of 5.1 years, the FFS was worse for patients on Stanford V compared with those on the other regimens (54% vs. 78% and 81% at 5 years; P < .01).[7][Level of evidence: 1iiDiii]

In a meta-analysis of 1,740 patients treated on 14 different trials, no improvement was observed in 10-years' OS for patients with advanced-stage HL who received combined modality therapy versus chemotherapy alone.[8][Level of evidence: 1iiA] Three prospective randomized trials and a meta-analysis did not show a benefit in OS from the addition of consolidative radiation therapy to chemotherapy for patients with advanced-stage disease.[9-12] The lack of difference in OS was attributed to a greater number of second malignancies and poorer response and survival after relapse among patients who received combined modality therapy.

Proposed clinical trials will explore consolidation for patients with positive positron emission tomography testing after four cycles of ABVD.

Treatment options:

• ABVD for six to eight cycles.
• ABVD for six to eight cycles plus IF-XRT for some patients with bulky disease.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage III adult Hodgkin lymphoma and stage IV adult Hodgkin lymphoma. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. Hasenclever D, Diehl V: A prognostic score for advanced Hodgkin's disease. International Prognostic Factors Project on Advanced Hodgkin's Disease. N Engl J Med 339 (21): 1506-14, 1998.  [PUBMED Abstract]
   
   
2. Canellos GP, Anderson JR, Propert KJ, et al.: Chemotherapy of advanced Hodgkin's disease with MOPP, ABVD, or MOPP alternating with ABVD. N Engl J Med 327 (21): 1478-84, 1992.  [PUBMED Abstract]
   
   
3. Canellos GP, Niedzwiecki D: Long-term follow-up of Hodgkin's disease trial. N Engl J Med 346 (18): 1417-8, 2002.  [PUBMED Abstract]
   
   
4. Duggan DB, Petroni GR, Johnson JL, et al.: Randomized comparison of ABVD and MOPP/ABV hybrid for the treatment of advanced Hodgkin's disease: report of an intergroup trial. J Clin Oncol 21 (4): 607-14, 2003.  [PUBMED Abstract]
   
   
5. Johnson PW, Radford JA, Cullen MH, et al.: Comparison of ABVD and alternating or hybrid multidrug regimens for the treatment of advanced Hodgkin's lymphoma: results of the United Kingdom Lymphoma Group LY09 Trial (ISRCTN97144519). J Clin Oncol 23 (36): 9208-18, 2005.  [PUBMED Abstract]
   
   
6. Horning SJ, Hoppe RT, Breslin S, et al.: Stanford V and radiotherapy for locally extensive and advanced Hodgkin's disease: mature results of a prospective clinical trial. J Clin Oncol 20 (3): 630-7, 2002.  [PUBMED Abstract]
   
   
7. Gobbi PG, Levis A, Chisesi T, et al.: ABVD versus modified stanford V versus MOPPEBVCAD with optional and limited radiotherapy in intermediate- and advanced-stage Hodgkin's lymphoma: final results of a multicenter randomized trial by the Intergruppo Italiano Linfomi. J Clin Oncol 23 (36): 9198-207, 2005.  [PUBMED Abstract]
   
   
8. Loeffler M, Brosteanu O, Hasenclever D, et al.: Meta-analysis of chemotherapy versus combined modality treatment trials in Hodgkin's disease. International Database on Hodgkin's Disease Overview Study Group. J Clin Oncol 16 (3): 818-29, 1998.  [PUBMED Abstract]
   
   
9. Fabian CJ, Mansfield CM, Dahlberg S, et al.: Low-dose involved field radiation after chemotherapy in advanced Hodgkin disease. A Southwest Oncology Group randomized study. Ann Intern Med 120 (11): 903-12, 1994.  [PUBMED Abstract]
   
   
10. Aleman BM, Raemaekers JM, Tirelli U, et al.: Involved-field radiotherapy for advanced Hodgkin's lymphoma. N Engl J Med 348 (24): 2396-406, 2003.  [PUBMED Abstract]
    
    
11. Fermé C, Mounier N, Casasnovas O, et al.: Long-term results and competing risk analysis of the H89 trial in patients with advanced-stage Hodgkin lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte (GELA). Blood 107 (12): 4636-42, 2006.  [PUBMED Abstract]
    
    
12. Franklin JG, Paus MD, Pluetschow A, et al.: Chemotherapy, radiotherapy and combined modality for Hodgkin's disease, with emphasis on second cancer risk. Cochrane Database Syst Rev (4): CD003187, 2005.  [PUBMED Abstract]
    
    

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