R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
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| ClinicalTrials.gov Identifier: NCT01133158 |
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Recruitment Status :
Completed
First Posted : May 28, 2010
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
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Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Brief Summary:
Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Hodgkin's Lymphoma | Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | July 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: R-BMD
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years
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Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
Other Name: R-BMD |
Primary Outcome Measures :
- Response Rate [ Time Frame: 7 years ]
The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
Complete Remission (CR):
Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved
Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD
Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD
Progressive Disease (PD):
SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
Secondary Outcome Measures :
- Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. [ Time Frame: 7 years ]
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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 |
Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years.
- Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL.
- Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy).
- ECOG ≤ 2.
- Signed written informed consent.
Exclusion Criteria:
- Clinical suspicion or documentation of histological transformation.
- Have received prior chemotherapy scheme, first line without Rituximab.
- Prior autologous or allogeneic.
- CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
- Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)
- HCV infection. HIV infection or other conditions of serious immunosuppression.
- Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
- Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%.
- Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma.
- Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma.
- Women who are nursing or pregnant. Women of childbearing potential will be included prior pregnancy test serum / urine negative. Use effective contraception to be kept for 1 year after cessation of rituximab.
- Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
- Severe acute or chronic infection in activity.
- Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
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): NCT01133158
Locations
Show 41 study locations
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
| Principal Investigator: | Francisco Javier Peñalver Párraga, MD | Hospital Universitario Fundación Alcorcón | |
| Principal Investigator: | Javier De la Serna Torroba, MD | Hospital 12 de Octubre | |
| Principal Investigator: | Francisca Oña Compan, MD | Hospital de Getafe. | |
| Principal Investigator: | Patricia Font López, MD | Gregorio Marañón Hospital | |
| Principal Investigator: | Secundino Ferrer Bordas, MD | Hospital Dr. Peset | |
| Principal Investigator: | José Ramón Mayans Ferrer, MD | Hospital Arnau de Vilanova | |
| Principal Investigator: | Eulogio Conde García, MD | Hospital Marqués de Valdecilla | |
| Principal Investigator: | José Antonio Márquez Navarro, MD | Hospital de Basurto | |
| Principal Investigator: | Ernesto Pérez Persona, MD | Hospital Txagorritxu | |
| Principal Investigator: | Garazi Letamendi Madariaga, MD | Hospital de Galdakao | |
| Principal Investigator: | Pilar Giraldo Castellanos, MD | Hospital Miguel Servet | |
| Principal Investigator: | Luis Palomera Bernal, MD | Hospital Clínico de Zaragoza | |
| Principal Investigator: | Andrés López Hernández, MD | Hospital Vall d´Hebron | |
| Principal Investigator: | Blanca Sánchez González, MD | Hospital del Mar | |
| Principal Investigator: | José Luis Sánchez-Majado, MD | Hospital San Juan de Alicante | |
| Principal Investigator: | Antonio Gutiérrez García, MD | Hospital Son Espases | |
| Principal Investigator: | Francisco Javier Capote Huelva, MD | Hospital Universitario Puerta del Mar | |
| Principal Investigator: | Fátima de la Cruz, MD | Hospital Virgen del Rocío | |
| Principal Investigator: | Mª José Ramírez, MD | Hospital de Jerez | |
| Principal Investigator: | Fernando Carnicero González, MD | Hospital San Pedro de Alcantara | |
| Principal Investigator: | Mª José Rodríguez Salazar, MD | Hospital Universitario de Canarias | |
| Principal Investigator: | Miguel Ángel Canales Albendea, MD | Hospital La Paz | |
| Principal Investigator: | José Antonio García Marco, MD | Hospital Puerta de Hierro | |
| Principal Investigator: | Carlos Montalbán Sanz, MD | Hospital Universitario Ramon y Cajal | |
| Principal Investigator: | Rosalía Riaza Grau, MD | Hospital Severo Ochoa | |
| Principal Investigator: | Mª Dolores Caballero Barrigón, MD | Hospital de Salamanca | |
| Principal Investigator: | Mª Jesús Peñarrubia Ponce, MD | Hospital Río Hortega | |
| Principal Investigator: | José Antonio Queizán, MD | Hospital de Segovia | |
| Principal Investigator: | Roberto Hernández Martín, MD | Hospital Virgen de la Concha | |
| Principal Investigator: | Mª José Terol Castera, MD | Hospital Clínico de Valencia | |
| Principal Investigator: | Félix Carbonell, MD | Hospital General Universitario de Valencia | |
| Principal Investigator: | María Rosario Varela Gómez, MD | Complejo Hospitalario A Coruña | |
| Principal Investigator: | José Luis Bello López, MD | C. H. U. Santiago | |
| Principal Investigator: | Carlos Panizo, MD | Clínica Universitaria de Navarra | |
| Principal Investigator: | Juan Manuel Sancho Cia, MD | Germans Trias i Pujol Hospital | |
| Principal Investigator: | Armando López Guillermo, MD | Hospital Clínic i Provincial | |
| Principal Investigator: | Elena Pérez Ceballos, MD | Hospital Morales Meseguer | |
| Principal Investigator: | Andrés Sánchez Salinas, MD | Hospital Universitario Virgen de la Arrixaca | |
| Principal Investigator: | Mª Soledad Durán Nieto, MD | Hospital de Jaén | |
| Principal Investigator: | Manuel Espeso de Haro, MD | Hospital Carlos Haya | |
| Principal Investigator: | Joan Bargay Lleonart, MD | Hospital Son Llàtzer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
| ClinicalTrials.gov Identifier: | NCT01133158 |
| Other Study ID Numbers: |
R-BMD GELTAMO 08 |
| First Posted: | May 28, 2010 Key Record Dates |
| Results First Posted: | November 1, 2018 |
| Last Update Posted: | November 1, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
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Follicular non-Hodgkin's lymphoma relapse refractory |
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 Dexamethasone Rituximab Bendamustine Hydrochloride Mitoxantrone Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors |
Physiological Effects of Drugs Antirheumatic Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Analgesics |