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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

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ClinicalTrials.gov Identifier: NCT02012088
Recruitment Status : Active, not recruiting
First Posted : December 16, 2013
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

Condition or disease Intervention/treatment Phase
Lymphoma Drug: RCOMP Drug: RCHOP Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomised, Multicentre Study With Two Treatment Arms (R-COMP Versus R-CHOP) in Newly Diagnosed Elderly Patients (≥60 Years) With Non-localised Diffuse Large B-cell Lymphoma (DLBCL)/Follicular Lymphoma Grade IIIb.
Actual Study Start Date : October 11, 2013
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: RCOMP

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
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
Other Names:
  • Rituximab
  • Myocet
  • Cyclophosphamide
  • Vincristine
  • Prednisone

Active Comparator: RCHOP

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
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
Other Names:
  • Rituximab
  • Doxorubicin
  • Cyclophosphamide
  • Vincristine
  • Prednisone 60 mg/m2




Primary Outcome Measures :
  1. Subclinical cardiac toxicity [ Time Frame: Day 135 ]
    Subclinical cardiac toxicity determined by the percentage of measurings experiencing a decrease in LEVF determined by echocardiography with final LEVF <55% at day 135

  2. Subclinical cardiac toxicity [ Time Frame: Day 225 ]
    Subclinical cardiac toxicity determined by the percentage of measurings experiencing a decrease in LEVF determined by echocardiography with final LEVF <55% at day 225


Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 and 5 years ]
    Event free survial, progression free survival and overall survival at 2 and 5 years.

  2. Response rate [ Time Frame: Day 135 ]
    Overall response rates and complete responses evaluated by the International Harmonization Project for response criteria in lymphoma

  3. Cardiac/cardiovascular toxicity [ Time Frame: During 5 years ]
    Rate of cardiac/cardiovascular toxicity according to the CTC criteria (version 4.0) of the National Cancer Institute (NCI) during the treatment and during 5 years

  4. Toxicity (except cardiac) [ Time Frame: During 2 years ]
    No cardiotoxicity according to the CTC criteria (version 4.0) of the NCI during 24 months

  5. Cardiac biomarkers [ Time Frame: During 12 months ]
    Cardiotoxicity determined by elevated values of troponin and NT-proBNP and decreased values of LEVF determined during 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012088


Locations
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Spain
Hospital Universitario de Alava
Vitoria, Alava, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragón, Spain, 50009
Hospital de Cabueñes
GIjón, Asturas, Spain, 33203
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
ICO- Hospital Duran i Reynals
L´Hospitalet de Llobregat, Barcelona, Spain, 08908
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitario de Salamanca
Salamanca, Castilla Y Leon, Spain, 37007
Hospital Clínico Universitario de Valladolid
Valladolid, Castilla Y Leon, Spain, 47005
Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital del Mar
Barcelona, Spain, 08003
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
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Principal Investigator: Dr. Alejandro Martin Hospital Universitario de Salamanca
Principal Investigator: Dr. Juan Manuel Sancho Germans Trias i Pujol Hospital
Principal Investigator: Dr. Francisco Gual Germans Trias i Pujol Hospital

Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT02012088     History of Changes
Other Study ID Numbers: GEL-R-COMP-2013
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2018
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Follicular lymphoma, large B-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors