R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma

NCT00992030 | Terminated Phase 3

• 2 other identifiers: FM-HD09-012009-009431-30
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 11

Brief Summary

Combined modality therapy has then emerged as the standard of care for limited-stage Hodgkin's lymphoma and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy that is devoid of alkylating agents and associated with a low potential for gonadal toxicity and leukemogenesis, is currently considered a gold standard. Nevertheless, the disadvantage to combine radiotherapy to ABVD is represented by late cardiovascular events (myocardial dysfunction and coronary or valvular disease), especially when the heart is within the radiation field; bleomycin pulmonary toxicity also is increased in conjunction with RT and secondary tumors, in particular in the RT fields. This study aims at treating patients with limited disease with multiagent chemotherapy alone, without irradiation, and using radiotherapy only for relapses.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• 3-year failure free survival. Failure is defined as disease progression during treatment, achievement of less than complete remission (CR) after the total planned therapy, relapse during follow-up or death from any cause.

  Three-year failure free survival from randomization

Secondary Outcomes (2)

• Event-free survival including, besides failures, late serious treatment-related events

  7 years from randomization

• Overall survival, all causes included

  7 year from randomozation

Study Arms (2)

ARM A

EXPERIMENTAL

Rituximab plus ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 4 cycles

Drug: Rituximab

ARM B

ACTIVE COMPARATOR

ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for 4 cycles followed by involved field irradiation

Radiation: Involved field irradiation

Interventions

Rituximab DRUG

I.V. infusion weekly x 6 weeks at a dose of 375 mg/m2

Also known as: Drug: rituximab, Drug: ABVD regimen, Drug: doxorubicin hydrocloride, Drug: bleomycin, Drug: vinblastine, Drug: dacarbazine

ARM A

Involved field irradiation RADIATION

Radiation therapy, limited to initially involved nodal sites, will start within four weeks from the last cycle of ABVD chemotherapy and after complete restaging with TAC total-body and PET total-body. The planned total dose is 30,6 Gy.

Also known as: Drug: ABVD regimen, Drug: doxorubicin hydrochloride, Drug: bleomycin, Drug: vinblastine, Drug: dacarbazine, Radiation: radiation therapy

ARM B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically confirmed classical Hodgkin lymphoma (cHL)
• Limited-stage disease defined as stage I or IIA with no areas of bulky disease
• Measurable disease according to the Cheson criteria
• Age \>=18 years
• Adequate bone marrow reserve (ANC \>= 1,500/uL, Platelet \> 100,000/uL)
• LVEF \>= 50% by MUGA scan or echocardiogram
• Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl, AST or ALT \<2x ULN
• Bi-dimensionally measurable disease
• Use of effective means of contraception
• Signed informed consent form

You may not qualify if:

• Lymphocyte predominant HL
• Prior chemotherapy or radiation therapy
• Severe pulmonary disease as judged by the PI including COPD and asthma
• Presence of CNS lymphoma
• Concomitant malignancies or previous malignancies (exception made for adequately treated basal or squamous cell carcinoma of the skin)
• Active infection requiring treatment with intravenous therapy
• Known HIV infection
• Active hepatitis B or C
• Pregnancy or lactation and women of child bearing age who are not practicing adequate contraception

Sponsors & Collaborators

• Fondazione Michelangelo: lead

Study Sites (11)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Ospedali Riuniti Umberto I

Ancona, 60020, Italy

Location

Ospedali Riuniti

Bergamo, 24100, Italy

Location

Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Ospedale Roberto Binaghi

Cagliari, 09126, Italy

Location

Azienda Ospedaliera Vittorio Emanuele Ferrarotto

Catania, 95124, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Azienda Ospedaliero Universitaria S. Luigi Gonzaga

Orbassano, 10043, Italy

Location

Gianpietro Semenzato

Padua, 35128, Italy

Location

Ospedali Riuniti Villa Sofia Cervello

Palermo, 90146, Italy

Location

Ospedale San Carlo

Potenza, 85100, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Rituximab; ABVD protocol; Bleomycin; Vinblastine; Dacarbazine; Doxorubicin; Radiotherapy

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)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Therapeutics

Study Officials

• Alessandro M Gianni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 19, 2021

Record last verified: 2019-07

Locations

IT (10); US (1)