R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial

NCT ID: NCT01133158

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2016-07-31

Brief Summary

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

Detailed Description

Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-BMD

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years

Group Type: EXPERIMENTAL

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

R-BMD

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years.

2. 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.

3. 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).

4. ECOG ≤ 2.

5. Signed written informed consent.

Exclusion Criteria

1. Clinical suspicion or documentation of histological transformation.

2. Have received prior chemotherapy scheme, first line without Rituximab.

3. Prior autologous or allogeneic.

4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).

5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)

6. HCV infection. HIV infection or other conditions of serious immunosuppression.

7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.

8. Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%.

9. Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma.

10. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma.

11. 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.

12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.

13. Severe acute or chronic infection in activity.

14. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Javier Peñalver Párraga, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Fundación Alcorcón

Javier De la Serna Torroba, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Francisca Oña Compan, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Getafe.

Patricia Font López, MD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Secundino Ferrer Bordas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Peset

José Ramón Mayans Ferrer, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Arnau de Vilanova

Eulogio Conde García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

José Antonio Márquez Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Basurto

Ernesto Pérez Persona, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Txagorritxu

Garazi Letamendi Madariaga, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Galdakao

Pilar Giraldo Castellanos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Luis Palomera Bernal, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Zaragoza

Andrés López Hernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d´Hebron

Blanca Sánchez González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

José Luis Sánchez-Majado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Juan de Alicante

Antonio Gutiérrez García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Espases

Francisco Javier Capote Huelva, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta del Mar

Fátima de la Cruz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Rocío

Mª José Ramírez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Jerez

Fernando Carnicero González, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital San Pedro de Alcantara

Mª José Rodríguez Salazar, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Canarias

Miguel Ángel Canales Albendea, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Paz

José Antonio García Marco, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro

Carlos Montalbán Sanz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Rosalía Riaza Grau, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Severo Ochoa

Mª Dolores Caballero Barrigón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Salamanca

Mª Jesús Peñarrubia Ponce, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Río Hortega

José Antonio Queizán, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Segovia

Roberto Hernández Martín, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Concha

Mª José Terol Castera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Valencia

Félix Carbonell, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Valencia

María Rosario Varela Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario A Coruña

José Luis Bello López, MD

Role: PRINCIPAL_INVESTIGATOR

C. H. U. Santiago

Carlos Panizo, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria de Navarra

Juan Manuel Sancho Cia, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Armando López Guillermo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic i Provincial

Elena Pérez Ceballos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Morales Meseguer

Andrés Sánchez Salinas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de la Arrixaca

Mª Soledad Durán Nieto, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Jaén

Manuel Espeso de Haro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Carlos Haya

Joan Bargay Lleonart, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Llàtzer

Locations

Complejo Hospitalario Universitario de Santiago

Santiago, A Coruña, Spain

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, Spain

Hospital San Juan de Alicante

Sant Joan d'Alacant, Alicante, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital de Galdakao

Galdakao, Bilbao, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Fundación de Alcorcón

Alcorcón, Madrid, Spain

Hospital de Getafe

Getafe, Madrid, Spain

Hospital Severo Ochoa

Leganés, Madrid, Spain

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Virgen de Arrixaca

El Palmar, Murcia, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Vall d´Hebron

Barcelona, , Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital de Basurto

Bilbao, , Spain

Hospital Puerta del Mar

Cadiz, , Spain

Hospital San Pedro Alcántara

Cáceres, , Spain

Hospital de Jaén

Jaén, , Spain

Hospital Gregorio Marañón

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Complejo Hospitalario Carlos Haya

Málaga, , Spain

Hospital Morales Meseguer

Murcia, , Spain

Hospital de Salamanca

Salamanca, , Spain

Hospital General de Segovia

Segovia, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital General de Valencia

Valencia, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Hospital Río Hortega

Valladolid, , Spain

Hospital Virgen de la Concha

Zamora, , Spain

Hospital Clínico de Zaragoza

Zaragoza, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, Sancho JM, Ramirez MJ, Terol MJ, Capote FJ, Gutierrez A, Sanchez B, Lopez A, Salar A, Rodriguez-Caravaca G, Canales M, Caballero MD; GELTAMO (The Spanish Lymphoma Cooperative Group). Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-6966. doi: 10.1002/cam4.2555. Epub 2019 Oct 1.

Reference Type: DERIVED

PMID: 31573746 (View on PubMed)

Other Identifiers

R-BMD GELTAMO 08

Identifier Type: -

Identifier Source: org_study_id