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

NCT01133158 | Completed Phase 2 Results

• 1 other identifier: R-BMD GELTAMO 08
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 41

Brief Summary

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

Conditions

Non-Hodgkin's Lymphoma

Keywords

Follicular non-Hodgkin's lymphoma relapse refractory

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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

  7 years

Secondary Outcomes (1)

• Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.

  7 years

Study Arms (1)

R-BMD

EXPERIMENTAL

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

Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone

Interventions

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone 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

Also known as: R-BMD

R-BMD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (41)

Complejo Hospitalario Universitario de Santiago

Santiago, A Coruña, 15706, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Hospital San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de Galdakao

Galdakao, Bilbao, 48960, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Fundación de Alcorcón

Alcorcón, Madrid, 289222, Spain

Location

Hospital de Getafe

Getafe, Madrid, 28901, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, 07010, Spain

Location

Hospital Son Espases

Palma de Mallorca, Mallorca, 07014, Spain

Location

Hospital Universitario Virgen de Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital San Pedro Alcántara

Cáceres, 10002, Spain

Location

Hospital de Jaén

Jaén, 23007, Spain

Location

Hospital Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Complejo Hospitalario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Morales Meseguer

Murcia, 30008, Spain

Location

Hospital de Salamanca

Salamanca, 37007, Spain

Location

Hospital General de Segovia

Segovia, 42002, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital General de Valencia

Valencia, 46014, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Hospital Río Hortega

Valladolid, 47012, Spain

Location

Hospital Virgen de la Concha

Zamora, 49022, Spain

Location

Hospital Clínico de Zaragoza

Zaragoza, 50009, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 31573746 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Bendamustine Hydrochloride; Mitoxantrone; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Francisco Javier Peñalver
• Organization: GELTAMO

fjpenalver@fhalcorcon.es

91 621 98 24

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: May 28, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2016
• Last Updated: November 1, 2018
• Results First Posted: November 1, 2018

Record last verified: 2018-02

Locations

ES (41)