Clinical Trial to Evaluate R-COMP Versus R-CHOP in Newly Diagnosed Patients With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb

NCT02012088 | Completed Phase 2 DMC

• 1 other identifier: GEL-R-COMP-2013
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 14

Brief Summary

The Phase II study proposed here assesses the hypothesis that replacing doxorubicin by Myocet® in the R-CHOP regimen would yield comparable antitumour efficacy with a lower cardiotoxicity for first-line treatment in elderly patients with non-localised DLBCL/Follicular lymphoma grade IIIb

Conditions

Lymphoma

Keywords

Follicular lymphoma, large B-cell lymphoma

Outcome Measures

Primary Outcomes (2)

• Subclinical cardiac toxicity

  Subclinical cardiac toxicity determined by the percentage of measurings experiencing a decrease in LEVF determined by echocardiography with final LEVF \<55% at day 135

  Day 135

• Subclinical cardiac toxicity

  Subclinical cardiac toxicity determined by the percentage of measurings experiencing a decrease in LEVF determined by echocardiography with final LEVF \<55% at day 225

  Day 225

Secondary Outcomes (5)

• Survival

  2 and 5 years

• Response rate

  Day 135

• Cardiac/cardiovascular toxicity

  During 5 years

• Toxicity (except cardiac)

  During 2 years

• Cardiac biomarkers

  During 12 months

Study Arms (2)

RCOMP

EXPERIMENTAL

R-COMP Regimen: Day 1: Rituximab 375 mg/m2; Myocet® 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

Drug: RCOMP

RCHOP

ACTIVE COMPARATOR

R-CHOP Regimen: Day 1: Rituximab 375 mg/m2; Doxorubicin 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

Drug: RCHOP

Interventions

RCOMP DRUG

Day 1: Rituximab 375 mg/m2; Myocet® 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

Also known as: Rituximab, Myocet, Cyclophosphamide, Vincristine, Prednisone

RCOMP

RCHOP DRUG

Day 1: Rituximab 375 mg/m2; Doxorubicin 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles

Also known as: Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone 60 mg/m2

RCHOP

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥60 years of age
• Histological confirmed DLBCL/follicular lymphoma grade IIIb by WHO classification, with any IPI (International Prognostic Index)
• Newly diagnosed, with no previous treatment
• Non-localised stage, i.e. lymphoma that does not fit into a single radiotherapy field (including clinical stage IA with large tumour mass until stage IV) with at least one measurable lesion
• ECOG performance status 0 to 2
• Present appropriate haematologic, liver (ALT or AST \< 2.5 ULN ? upper limit of normal) and renal functions (creatinine \< 2.5 ULN) , unless changes are secondary to lymphoma
• LVEF at rest ? 55%, with no documented history of congestive heart failure (CHF), serious arrhythmia or acute myocardial infarction

You may not qualify if:

• Clinical stage I without large tumour mass or clinical stage IIA with fewer than three affected areas (stage-IIB patients are considered suitable, regardless of the number of affected areas)
• CNS infiltration
• Transformed lymphoma, although with no previous treatment, as well as other histological subtypes such as mantle cell lymphoma, peripheral T-cell lymphoma and its variants and post-transplant lymphoproliferative syndrome
• Clinically significant secondary cardiovascular disease
• Signs of any severe, acute or chronic and active infection
• Concurrent malignancy or history of other neoplasia except basal cell carcinoma (BCC) and cervical or breast carcinoma in situ (CIN)
• Patients with positive results in the HBV, HIV or HCV RNA tests
• Any previous treatment for DLBCL/follicular lymphoma grade IIIb

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (14)

Hospital Universitario de Alava

Vitoria-Gasteiz, Alava, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, 50009, Spain

Location

Hospital de Cabueñes

Gijón, Asturas, 33203, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

ICO- Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, 47005, Spain

Location

Hospital Fundación de Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Related Publications (8)

• Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

  PMID: 17242396 BACKGROUND

• Rigacci L, Mappa S, Nassi L, Alterini R, Carrai V, Bernardi F, Bosi A. Liposome-encapsulated doxorubicin in combination with cyclophosphamide, vincristine, prednisone and rituximab in patients with lymphoma and concurrent cardiac diseases or pre-treated with anthracyclines. Hematol Oncol. 2007 Dec;25(4):198-203. doi: 10.1002/hon.827.

  PMID: 17654614 RESULT

• Luminari S, Montanini A, Caballero D, Bologna S, Notter M, Dyer MJS, Chiappella A, Briones J, Petrini M, Barbato A, Kayitalire L, Federico M. Nonpegylated liposomal doxorubicin (MyocetTM) combination (R-COMP) chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL): results from the phase II EUR018 trial. Ann Oncol. 2010 Jul;21(7):1492-1499. doi: 10.1093/annonc/mdp544. Epub 2009 Dec 11.

  PMID: 20007997 RESULT

• Levine AM, Tulpule A, Espina B, Sherrod A, Boswell WD, Lieberman RD, Nathwani BN, Welles L. Liposome-encapsulated doxorubicin in combination with standard agents (cyclophosphamide, vincristine, prednisone) in patients with newly diagnosed AIDS-related non-Hodgkin's lymphoma: results of therapy and correlates of response. J Clin Oncol. 2004 Jul 1;22(13):2662-70. doi: 10.1200/JCO.2004.10.093.

  PMID: 15226333 RESULT

• Cardinale D, Sandri MT, Colombo A, Colombo N, Boeri M, Lamantia G, Civelli M, Peccatori F, Martinelli G, Fiorentini C, Cipolla CM. Prognostic value of troponin I in cardiac risk stratification of cancer patients undergoing high-dose chemotherapy. Circulation. 2004 Jun 8;109(22):2749-54. doi: 10.1161/01.CIR.0000130926.51766.CC. Epub 2004 May 17.

  PMID: 15148277 RESULT

• Cardinale D, Sandri MT. Role of biomarkers in chemotherapy-induced cardiotoxicity. Prog Cardiovasc Dis. 2010 Sep-Oct;53(2):121-9. doi: 10.1016/j.pcad.2010.04.002.

  PMID: 20728699 RESULT

• Cardinale D, Salvatici M, Sandri MT. Role of biomarkers in cardioncology. Clin Chem Lab Med. 2011 Sep 6;49(12):1937-48. doi: 10.1515/CCLM.2011.692.

  PMID: 21892906 RESULT

• Sancho JM, Fernandez-Alvarez R, Gual-Capllonch F, Gonzalez-Garcia E, Grande C, Gutierrez N, Penarrubia MJ, Batlle-Lopez A, Gonzalez-Barca E, Guinea JM, Gimeno E, Penalver FJ, Fuertes M, Bastos M, Hernandez-Rivas JA, Moraleda JM, Garcia O, Sorigue M, Martin A. R-COMP versus R-CHOP as first-line therapy for diffuse large B-cell lymphoma in patients >/=60 years: Results of a randomized phase 2 study from the Spanish GELTAMO group. Cancer Med. 2021 Feb;10(4):1314-1326. doi: 10.1002/cam4.3730. Epub 2021 Jan 25.

  PMID: 33492774 DERIVED

Related Links

• Sponsor web page

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; Doxorubicin; Cyclophosphamide; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; 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; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Dr. Alejandro Martin

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Dr. Juan Manuel Sancho

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Dr. Francisco Gual

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: December 16, 2013
• Study Start: October 11, 2013
• Primary Completion: October 1, 2016
• Study Completion: August 1, 2021
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

ES (14)