Study Comparing ABVD vs BEACOPP in Advanced Hodgkin's Lymphoma

NCT01251107 | Completed Phase 3

• 1 other identifier: 41/99
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin lymphoma; ABVD; BEACOPP; Salvage high dose chemotherapy

Outcome Measures

Primary Outcomes (1)

• Freedom from first progression at 5 years

  After a median of 5 years from start of the study

Secondary Outcomes (4)

• Freedom from second progression at 5 years

  After a median of 5 years from start of protocol

• Overall survival at 5 years

  After a median of 5 years from start of the protocol

• Number of participants with acute adverse events at initial therapy and at salvage therapy as a measure of safety and tolerability

  After 3 months from last intervention

• Number of participants long term sequelae

  After a median of 10 years

Study Arms (2)

Arm B

EXPERIMENTAL

BEACOPP (Bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) for 4 escalated cycles followed by 4 standard cycles

Drug: Bleomycin; Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone

Arm A

ACTIVE COMPARATOR

ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 6 to 8 cycles

Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine

Interventions

Bleomycin DRUG

10 mg/m2 IV day 8 during cycles 1 to 8

Also known as: Bleomicina Teva

Arm B

Etoposide DRUG

200 mg/m2 iv on days 1 to 3 during cycles 1 to 4; 100 mg/m2 iv on days 1 to 3 during cycles 5 to 8

Also known as: VP-16, Etoposide Teva

Arm B

Doxorubicin DRUG

35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8

Also known as: Adriblastina Pfizer

Arm B

Cyclophosphamide DRUG

1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8

Also known as: Endoxan Baxter

Arm B

Vincristine DRUG

1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8

Also known as: Vincristina Teva Italia

Arm B

Procarbazine DRUG

100 mg/m2 po from day 1 to 7 during cycles 1 to 8

Also known as: Natulan

Arm B

Prednisone DRUG

40 mg/m2 po from day 1 to 14 during cycles 1 to 8

Also known as: Deltacortene

Arm B

Vinblastine DRUG

6 mg/m2 iv on days 1 and 15 in each cycle

Also known as: Velbe

Arm A

Dacarbazine DRUG

375 mg/m2 iv on days 1 and 15 in each cycle

Also known as: Dacarbazina Medac

Arm A

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed, newly diagnosed Hodgkin's lymphoma (pathological review diagnosis 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 greater than 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 major respiratory disease
• No severe neurologic or psychiatric disease
• No other malignancy except basal cell carcinoma of the skin and/or in situ cervical carcinoma 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 of childbearing potential
• Written informed consent and consent to a regular follow-up in the outpatient clinic

You may not qualify if:

• Sever central nervous system or psychiatric disease
• History or current evidence of clinically significant cardiac disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease or myocardial 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

Sponsors & Collaborators

• Fondazione Michelangelo: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale di Tumori di Milano

Milan, Italy

Location

Related Publications (1)

• Viviani S, Zinzani PL, Rambaldi A, Brusamolino E, Levis A, Bonfante V, Vitolo U, Pulsoni A, Liberati AM, Specchia G, Valagussa P, Rossi A, Zaja F, Pogliani EM, Pregno P, Gotti M, Gallamini A, Rota Scalabrini D, Bonadonna G, Gianni AM; Michelangelo Foundation; Gruppo Italiano di Terapie Innovative nei Linfomi; Intergruppo Italiano Linfomi. ABVD versus BEACOPP for Hodgkin's lymphoma when high-dose salvage is planned. N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340.

  PMID: 21774708 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Bleomycin; Etoposide; Doxorubicin; Cyclophosphamide; Vincristine; Procarbazine; Prednisone; deltacortene; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Alessandro M Gianni, MD

  Fondazione IRCCS Istituto Nazionale Tumori di Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: December 1, 2010
• Study Start: March 1, 2000
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 13, 2015

Record last verified: 2011-02

Locations

IT (1)