Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

Last updated: August 11, 2015
Sponsor: Fondazione Michelangelo
Overall Status: Completed

Phase

3

Condition

Lymphoma

Platelet Disorders

Hematologic Cancer

Treatment

N/A

Clinical Study ID

NCT01251107
41/99
  • Ages 17-60
  • All Genders

Study Summary

The choice of a preferred first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related effects. To fully assess this balance, the treatment decision process should ideally take into account the outcome following a consistent second-line therapy, in particular when tolerated, widely applicable and highly effective salvage regimens exist, like in Hodgkin lymphoma failing initial chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological reviewdiagnosis available)

  • No prior treatment

  • Stage II B, III A and B, IV A and B

  • Normal hematopoietic function as measured by leucocytes equal to or greater than 3500/mm3, neutrophils equal to or greater than 1500/mm3, platelets equal to or greaterthan 100000/mm3

  • Normal renal function (serum creatinine < 1,5x ULN) and normal liver function (SGOT/SGPT equal to or lower than 2.5x ULN; bilirubin equal to or lower than 1.5x ULN)

  • No significant history or current evidence of cardiovascular disease, or majorrespiratory disease

  • No severe neurologic or psychiatric disease

  • No other malignancy except basal cell carcinoma of the skin and/or in situ cervicalcarcinoma of the uterus

  • Serological negativity for hepatitis B or C or HIV infection

  • ECOG performance status equal to or lower than 2

  • Life expectancy of at least three months

  • Effective contraception in all patients and a negative pregnancy test for women ofchildbearing potential

  • Written informed consent and consent to a regular follow-up in the outpatient clinic

Exclusion

Exclusion criteria:

  • Sever central nervous system or psychiatric disease

  • History or current evidence of clinically significant cardiac disease (congestiveheart failure, uncontrolled hypertension, unstable coronary artery disease ormyocardial infarction or severe arrhythmias. Left ventricular ejection fraction < 50%at rest by echocardiography or < 55% by isotopic measurement

  • Serological positivity for HBV, HCV or HIV

  • History or current evidence of malignancy other than basal cell carcinoma of the skin,carcinoma in situ of the cervix

  • Lactating or pregnant women

Study Design

Total Participants: 331
Study Start date:
March 01, 2000
Estimated Completion Date:
November 30, 2009

Study Description

During the last two decades ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) has been considered as the standard of care for advanced HL, however 20-30% of the patients fail to achieve a durable complete remission and need a salvage treatment. After a state-of-the art-salvage program including high-dose chemotherapy and autologous hematopoietic stem cell support (ASCT) at least half of these patients achieve a durable disease control. Recently the German Hodgkin Study Group (GHSG) has developed a new regimen, BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone), administered with or without dose escalation. In an interim analysis after 23 months follow-up, BEACOPP demonstrated a higher activity compared to COPP/ABVD with a superior freedom from treatment failure (84% versus 75%, P=.034). Despite the improved efficacy a substantial proportion of patients receiving escalated BEACOPP experienced severe acute hematologic toxicity (grade 3-4 leucopoenia, thrombocytopenia and anemia occurred in 78% , 36% and 27% of the cycles administered, respectively) and 1.8% fatal acute toxicities were reported. Moreover of greater concern is the incidence of almost fatal secondary acute leukemia and myelodysplastic syndrome (3 cases in 323 patients). The choice of first-line treatment requires balancing the desire for optimal disease control with the occurrence of early and late treatment-related toxicities. Long-term outcome following an optimal salvage treatment, consisting in high-dose chemotherapy with ASCT should also be taken into consideration. In the present study we plan to compare the efficacy and toxicity of two therapeutic strategies consisting in two different first-line treatments followed by a pre-planned salvage program, when indicated

Connect with a study center

  • Fondazione IRCCS Istituto Nazionale di Tumori di Milano

    Milano,
    Italy

    Site Not Available

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