Efficacy Response Duration and Toxicity of Rituximab, Fludarabine, and Cyclophosphamide (RFC) as 1st Line Treatment and Rituximab (R) in Maintenance Treatment in Follicular Non Hodgkin (FNH) Lymphoma
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| ClinicalTrials.gov Identifier: NCT01124526 |
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Recruitment Status :
Completed
First Posted : May 17, 2010
Last Update Posted : May 17, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Hodgkin Lymphoma | Drug: Rituximab Fludarabine Cyclophosphamide | Phase 4 |
The use of monoclonal antibodies, specifically the chimerical humanized anti-CD20 monoclonal antibody (Rituximab, MabThera®) represents one of the most innovative aspects in the indolent lymphoma treatment. Preliminary data show from 40% to 50% of response with a median response duration between 6 and 11 months in patients with relapsing FL. This response rate increase when rituximab is administered as initial treatment.
Therefore, not only due to the clinical results but also to the tolerance, and based on an innovative mechanism of action and in its minimal toxicity, it seems reasonable to raise the possibility to incorporate the administration of the monoclonal antibody with chemotherapeutic agents.
The development of a new treatment scheme that includes Rituximab administration within treatment protocols that combine fludarabine and cyclophosphamide, whose results are better than the ones obtained with conventional treatments such as CHOP, should increase the molecular response rate and contribute therefore to increase the disease-free time interval (time to progression), without adding any toxicity, in addition to achieve a higher proportion of clinical responses (as global as complete responses). In order to increase the time interval to progression, a maintenance treatment will be carried out for 2 years, which has shown an evident benefit in the time to progression in preliminary studies.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective Non-randomized Multicenter Study to Assess the Efficacy Response Duration and Toxicity of RFC as First-line Treatment and R as Maintenance Treatment, in Patients Diagnosed of Follicular Non Hodgkin Lymphoma |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | July 2007 |
| Actual Study Completion Date : | July 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Rituximab, Fludarabine, ciclophosphamide
Patients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance: RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2) |
Drug: Rituximab Fludarabine Cyclophosphamide
Patients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance: RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2) FLUDARABINE(F):25 mg/m2 iv, day 1-3,(total dose 75 mg/m2) CICLOPHOSPHAMIDE(C)1000 mg/m2 iv, day 1,(total dose 1000 mg/m2) Other Names:
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- Time to progression disease [ Time Frame: 42 months ]
- Free-disease period [ Time Frame: 54 months ]
- Overall survival [ Time Frame: 54 months ]
- Safety of RFC [ Time Frame: 54 months ]
Toxicity is detailed and tabulate following the WHO classification. The safety analysis includes the incidence of adverse events (AE),vital signs and laboratory parameters.
Impact tables are made of AE following the classification of preferred term. Also include an analysis of the intensity of AE and their relation to the combiantion of study treatment.
- Molecular monitoring of clinical response [ Time Frame: 54 months ]Study of t14:18 translocation with altered expression of BCL2.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously untreated patients with grade I-III follicular lymphoma (grade B- D from the Working Formulation, centrofollicular lymphoma in the REAL classification), without evidence of histological transformation.
- Clinical diagnose by histological and/or immunophenotypical evaluation with positive results for CD 20 Mo Ab (node, bone marrow).
- Ann-Arbor stage II-IV.
- Male and female patients from 18 to 75 years old.
- Lack of related clinically uncontrolled diseases.
- Lack of VIH infection.
- Performance status (ECOG) of 0, 1, 2.
- Patients who voluntarily gave informed consent for the study participation.
- Life expectancy > 3 months.
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Women of childbearing age who do not accept to use an effective contraceptive method during the treatment and one year post-treatment.
- Immunodeficiency condition and autoimmune diseases.
- Patients with advanced clinically uncontrolled cardiac, hepatic or renal insufficiency, defined by the following criteria: total bilirubin, alkaline phosphatase or transaminases >2 x upper limit of normal, and serum creatinine value >2 x upper limit of normal.
- Patients previously treated with chemotherapy or radiotherapy.
- History of oncologic disease within the last 5 years, apart from non-melanoma cutaneous neoplasia or carcinoma in situ of uterine cervix.
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): NCT01124526
| Spain | |
| Hospital Infanta Cristina | |
| Badajoz, Badajoz_Extremadura, Spain, 06080 | |
| Hospital del Mar | |
| Barcelona, Barcelona_ Cataluña, Spain, 08003 | |
| Instituto Catalán de Oncología (ICO) | |
| Barcelona, Barcelona_Cataluña, Spain, 08907 | |
| Hospital San Pedro de Alcántara | |
| Cáceres, Cáceres_Extremadura, Spain, 10003 | |
| Hospital de Puerto Real | |
| Puerto Real, Cádiz_ Andalucía, Spain, 11510 | |
| Complejo Hospitalario Xeral_Calde | |
| Lugo, Lugo_ Galicia, Spain, 27004 | |
| Hospital Universitario Príncipe de Asturias | |
| Alcalá de Henares, Madrid, Spain, 28805 | |
| Fundación Hospital Alcorcón | |
| Alcorcón, Madrid, Spain, 28922 | |
| Hospital de Fuenlabrada | |
| Fuenlabrada, Madrid, Spain, 28943 | |
| Hospital Severo Ochoa | |
| Leganés, Madrid, Spain, 28911 | |
| Hospital de Móstoles | |
| Móstoles, Madrid, Spain, 28935 | |
| Hospital Clínico Universitario de Salamanca | |
| Salamanca, Salamanca_Castilla León, Spain, 37007 | |
| Hospital General de Segovia | |
| Segovia, Segovia_ Castilla León, Spain, 40001 | |
| Hospital Clínico del Río Hortega | |
| Valladolid, Valladolid_Castilla León, Spain, 47010 | |
| MD Anderson Internacional España | |
| Madrid, Spain, 28033 | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario La Paz | |
| Madrid, Spain, 28046 | |
| Study Director: | José F. Tomás, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | E . Prieto Pareja, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | F. Hernández Navarro, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | J. Díaz Mediavilla, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | C. Montalbán, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | F. Javier Peñañver, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | J. De La Serna, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | Mª Carmen Burgaleta, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | P. Sánchez Godoy, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | Mª Dolores Monteagudo, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | A. Fernández De Sevilla, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | Mª Jesús Peñarrubia, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | Mª Dolores Caballero Barrigón, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | R. Bajo Gómez, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | A. Paz Coll, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | J. A. Queizán, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | C. Cabrera Silva, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | O. Arija, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | P. Bravo Barahona, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon | |
| Principal Investigator: | A. Salar, MD | Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon |
| Responsible Party: | JF Tomás / MD, Asociación Española de Hematología y Hemoterapia |
| ClinicalTrials.gov Identifier: | NCT01124526 History of Changes |
| Other Study ID Numbers: |
LNHF-03. 04-0199 ( Other Identifier: Spanish Health Minyster (AEMPS) ) 2004/254 ( Other Identifier: Local Ethic Comities from Madrid CEIC_R MADRID ) |
| First Posted: | May 17, 2010 Key Record Dates |
| Last Update Posted: | May 17, 2010 |
| Last Verified: | May 2010 |
Keywords provided by Asociacion Espanola de Hematologia y Hemoterapia:
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R F C treatment in patients with Non Hodgkin Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Fludarabine phosphate Rituximab Fludarabine Vidarabine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |