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Completed

NCT Number: NCT01133158

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

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

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Complejo Hospitalario Universitario de Santiago, Santiago, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: R-BMD

Primary outcomes

  1. Response Rate

    Time frame: 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
May 28, 2010
Registry last updated
Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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