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

Non-Hodgkin's Lymphoma 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133158
• Other study ID #: R-BMD GELTAMO 08
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Est. completion date: July 2016

Study information

• Verified date: February 2018
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Fundación de Alcorcón	Alcorcón	Madrid
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d´Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital San Pedro Alcántara	Cáceres
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Universitario Virgen de Arrixaca	El Palmar	Murcia
Spain	Hospital de Galdakao	Galdakao	Bilbao
Spain	Hospital de Getafe	Getafe	Madrid
Spain	Hospital de Jaén	Jaén
Spain	Hospital de Jerez	Jerez de la Frontera	Cádiz
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Complejo Hospitalario Carlos Haya	Málaga
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Son Espases	Palma de Mallorca	Mallorca
Spain	Hospital Son Llàtzer	Palma de Mallorca	Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital de Salamanca	Salamanca
Spain	Hospital San Juan de Alicante	San Juan de Alicante	Alicante
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago	Santiago	A Coruña
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	Hospital Río Hortega	Valladolid
Spain	Hospital Txagorritxu	Vitoria	Alava
Spain	Hospital Virgen de la Concha	Zamora
Spain	Hospital Clínico de Zaragoza	Zaragoza
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.		7 years