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

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ClinicalTrials.gov Identifier: NCT01884441
Recruitment Status : Unknown
Verified January 2014 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : June 24, 2013
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE June 24, 2013
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Response Rate [ Time Frame: 3 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01884441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • overall response rate [ Time Frame: 3 months ]
    To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).
  • mobilization potential of the combination [ Time Frame: 3 months ]
    To evaluate the mobilization potential of BeGEV.
  • toxicity of the combination [ Time Frame: 3 months ]
    To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0.
  • Progression free survival (PFS), Overall Survival (OS). [ Time Frame: 2 years ]
    Progression free survival and overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
Official Title  ICMJE Phase II Study With Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Before High Dose Chemotherapy With Autologous Hematopoietic Stem Cells Transplant
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
Detailed Description

The aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (BeGEV) scheme efficacy as induction therapy to high dose chemotherapy with Allogeneic Hematopoietic Stem-Cell Transplantation (AHSCT) for patients with relapsed/refractory Hodglin's Lymphoma (HL).

Four BeGEV courses repeated every 3 weeks in the absence of any reasons listed in the paragraph 7.5; whenever an objective response is observed at disease evaluation performed after IV cycle patients undergo to high dose chemotherapy with AHSCT (conditioning regimens based on preference of each Centre).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Lymphoma
Intervention  ICMJE
  • Drug: Bendamustine

    Schedule:

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

    Other Name: Ribomustin
  • Drug: Gemcitabine
    Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
    Other Name: Gemzar
  • Drug: Vinorelbine
    Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
    Other Name: Navelbine
Study Arms  ICMJE Experimental: BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
Interventions:
  • Drug: Bendamustine
  • Drug: Gemcitabine
  • Drug: Vinorelbine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)
59
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01884441
Other Study ID Numbers  ICMJE ONC-2010-002
2010-022169-91 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Armando Santoro, MD, Istituto Clinico Humanitas
Study Sponsor  ICMJE Armando Santoro, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP