Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients

NCT01884441 | Unknown Phase 2

• 2 other identifiers: ONC-2010-0022010-022169-91
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects

Conditions

Hodgkin's Lymphoma

Keywords

Hodgkin; Lymphoma; refractory; relapsed

Outcome Measures

Primary Outcomes (1)

• Response Rate

  response rate after BeGEV in terms of Complete Response (CR)evaluated by fludeoxyglucose Positron emission tomography (FDG-PET) and Computed Tomography (CT-scan) after four cycles.

  3 months

Secondary Outcomes (4)

• overall response rate

  3 months

• mobilization potential of the combination

  3 months

• toxicity of the combination

  3 months

• Progression free survival (PFS), Overall Survival (OS).

  2 years

Study Arms (1)

BeGEV

EXPERIMENTAL

Bendamustine, Gemcitabine and Vinorelbine (BeGEV)

Drug: Bendamustine; Drug: Gemcitabine; Drug: Vinorelbine

Interventions

Bendamustine DRUG

Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles

Also known as: Ribomustin

BeGEV

Gemcitabine DRUG

Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles

Also known as: Gemzar

BeGEV

Vinorelbine DRUG

Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles

Also known as: Navelbine

BeGEV

Eligibility Criteria

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

You may qualify if:

• relapsed/refractory disease after receiving one line of standard chemotherapy
• history of classical Hodgkin's Lymphoma (HL)
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• at least one site of measurable nodal disease at baseline ≥ 1.5 cm
• Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L

You may not qualify if:

• Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL)
• prior radiation therapy ≤ 3 weeks prior to start of study treatment
• any concurrent anti-cancer therapy
• evidence of another malignancy not in remission or history of such a malignancy within the last 2 years.
• aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement
• known history of Human immunodeficiency virus (HIV)seropositivity
• hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis

Sponsors & Collaborators

• Armando Santoro, MD: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

RECRUITING

Related Publications (2)

• Santoro A, Mazza R, Pulsoni A, Re A, Bonfichi M, Zilioli VR, Zanni M, Merli F, Anastasia A, Luminari S, Annechini G, Gotti M, Peli A, Liberati AM, Di Renzo N, Castagna L, Giordano L, Ricci F, Carlo-Stella C. Five-year results of the BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma. Blood Adv. 2020 Jan 14;4(1):136-140. doi: 10.1182/bloodadvances.2019000984.

  PMID: 31935284 DERIVED

• Santoro A, Mazza R, Pulsoni A, Re A, Bonfichi M, Zilioli VR, Salvi F, Merli F, Anastasia A, Luminari S, Annechini G, Gotti M, Peli A, Liberati AM, Di Renzo N, Castagna L, Giordano L, Carlo-Stella C. Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study. J Clin Oncol. 2016 Sep 20;34(27):3293-9. doi: 10.1200/JCO.2016.66.4466. Epub 2016 Jul 5.

  PMID: 27382096 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma; Recurrence

Interventions

Bendamustine Hydrochloride; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Santoro, MD

CONTACT

+39 (0)2 8224; armando.santoro@humanitas.it

Rita Mazza, MD

CONTACT

+39 (0)2 8224; rita.mazza@humanitas.it

Study Design

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

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 24, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

IT (1)