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

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone

• Registration Number: NCT01133158
• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2013-12
• Study Completion: 2016-07
• Results First Submitted: 2017-03-07
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-21
• Last Update Submitted: 2018-02-21
• Results First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-BMD	Rituximab, Bendamustine, Mitoxantrone, Dexamethasone	Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years

Primary Outcome Measures

Name	Time	Method
Response Rate	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

Name	Time	Method
Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.	7 years

Trial Locations

Locations (41)

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago, A Coruña, Spain

Hospital Txagorritxu; 🇪🇸 Vitoria, Alava, Spain

Hospital San Juan de Alicante; 🇪🇸 San Juan de Alicante, 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

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