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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Sponsored by
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Follicular non-Hodgkin's lymphoma relapse refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Complejo Hospitalario Universitario de Santiago
  • Hospital Txagorritxu
  • Hospital San Juan de Alicante
  • Hospital Germans Trias i Pujol
  • Hospital de Galdakao
  • Hospital Marqués de Valdecilla
  • Hospital de Jerez
  • Hospital Fundación de Alcorcón
  • Hospital de Getafe
  • Hospital Severo Ochoa
  • Hospital Puerta de Hierro
  • Hospital Son Llàtzer
  • Hospital Son Espases
  • Hospital Universitario Virgen de Arrixaca
  • Clínica Universitaria de Navarra
  • Hospital Universitario de Canarias
  • Complejo Hospitalario Universitario A Coruña
  • Hospital del Mar
  • Hospital Vall d´Hebron
  • Hospital Clinic i Provincial
  • Hospital de Basurto
  • Hospital San Pedro Alcántara
  • Hospital Puerta del Mar
  • Hospital de Jaén
  • Hospital Gregorio Marañón
  • Hospital Ramón y Cajal
  • Hospital 12 de Octubre
  • Hospital La Paz
  • Hospital Morales Meseguer
  • Complejo Hospitalario Carlos Haya
  • Hospital de Salamanca
  • Hospital General de Segovia
  • Hospital Virgen del Rocío
  • Hospital Clínico Universitario de Valencia
  • Hospital General de Valencia
  • Hospital Arnau de Vilanova
  • Hospital Universitario Dr. Peset
  • Hospital Río Hortega
  • Hospital Virgen de la Concha
  • Hospital Clínico de Zaragoza
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-BMD

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2010
Last Updated
February 21, 2018
Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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1. Study Identification

Unique Protocol Identification Number
NCT01133158
Brief Title
R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
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 Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Follicular non-Hodgkin's lymphoma relapse refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-BMD
Arm Type
Experimental
Arm Description
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years
Intervention Type
Drug
Intervention Name(s)
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Other Intervention Name(s)
R-BMD
Intervention Description
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
Primary Outcome Measure Information:
Title
Response Rate
Description
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
Time Frame
7 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Peñalver Párraga, MD
Organizational Affiliation
Hospital Universitario Fundación Alcorcón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier De la Serna Torroba, MD
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisca Oña Compan, MD
Organizational Affiliation
Hospital de Getafe.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Font López, MD
Organizational Affiliation
Gregorio Marañón Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Secundino Ferrer Bordas, MD
Organizational Affiliation
Hospital Dr. Peset
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Ramón Mayans Ferrer, MD
Organizational Affiliation
Hospital Arnau de Vilanova
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eulogio Conde García, MD
Organizational Affiliation
Hospital Marqués de Valdecilla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Antonio Márquez Navarro, MD
Organizational Affiliation
Hospital de Basurto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernesto Pérez Persona, MD
Organizational Affiliation
Hospital Txagorritxu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Garazi Letamendi Madariaga, MD
Organizational Affiliation
Hospital de Galdakao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pilar Giraldo Castellanos, MD
Organizational Affiliation
Hospital Miguel Servet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Palomera Bernal, MD
Organizational Affiliation
Hospital Clínico de Zaragoza
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrés López Hernández, MD
Organizational Affiliation
Hospital Vall d´Hebron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blanca Sánchez González, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Luis Sánchez-Majado, MD
Organizational Affiliation
Hospital San Juan de Alicante
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Gutiérrez García, MD
Organizational Affiliation
Hospital Son Espases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Javier Capote Huelva, MD
Organizational Affiliation
Hospital Universitario Puerta del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fátima de la Cruz, MD
Organizational Affiliation
Hospital Virgen del Rocío
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª José Ramírez, MD
Organizational Affiliation
Hospital de Jerez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Carnicero González, MD
Organizational Affiliation
Hospital San Pedro de Alcantara
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª José Rodríguez Salazar, MD
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Canales Albendea, MD
Organizational Affiliation
Hospital La Paz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Antonio García Marco, MD
Organizational Affiliation
Hospital Puerta de Hierro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Montalbán Sanz, MD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosalía Riaza Grau, MD
Organizational Affiliation
Hospital Severo Ochoa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Dolores Caballero Barrigón, MD
Organizational Affiliation
Hospital de Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Jesús Peñarrubia Ponce, MD
Organizational Affiliation
Hospital Río Hortega
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Antonio Queizán, MD
Organizational Affiliation
Hospital de Segovia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Hernández Martín, MD
Organizational Affiliation
Hospital Virgen de la Concha
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª José Terol Castera, MD
Organizational Affiliation
Hospital Clínico de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Félix Carbonell, MD
Organizational Affiliation
Hospital General Universitario de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Rosario Varela Gómez, MD
Organizational Affiliation
Complejo Hospitalario A Coruña
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Luis Bello López, MD
Organizational Affiliation
C. H. U. Santiago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Panizo, MD
Organizational Affiliation
Clínica Universitaria de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Manuel Sancho Cia, MD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armando López Guillermo, MD
Organizational Affiliation
Hospital Clínic i Provincial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena Pérez Ceballos, MD
Organizational Affiliation
Hospital Morales Meseguer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrés Sánchez Salinas, MD
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Soledad Durán Nieto, MD
Organizational Affiliation
Hospital de Jaén
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Espeso de Haro, MD
Organizational Affiliation
Hospital Carlos Haya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Bargay Lleonart, MD
Organizational Affiliation
Hospital Son Llàtzer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital San Juan de Alicante
City
San Juan de Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Galdakao
City
Galdakao
State/Province
Bilbao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Fundación de Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
289222
Country
Spain
Facility Name
Hospital de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28901
Country
Spain
Facility Name
Hospital Severo Ochoa
City
Leganés
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital San Pedro Alcántara
City
Cáceres
ZIP/Postal Code
10002
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Complejo Hospitalario Carlos Haya
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital General de Segovia
City
Segovia
ZIP/Postal Code
42002
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Río Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital Virgen de la Concha
City
Zamora
ZIP/Postal Code
49022
Country
Spain
Facility Name
Hospital Clínico de Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31573746
Citation
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.
Results Reference
derived

Learn more about this trial

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

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