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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

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

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Bendamustine Drug: Gemcitabine Drug: Vinorelbine Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)).

  2. mobilization potential of the combination [ Time Frame: 3 months ]
    To evaluate the mobilization potential of BeGEV.

  3. 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.

  4. Progression free survival (PFS), Overall Survival (OS). [ Time Frame: 2 years ]
    Progression free survival and overall survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884441


Contacts
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Contact: Armando Santoro, MD +39 (0)2 8224 ext 4080 armando.santoro@humanitas.it
Contact: Rita Mazza, MD +39 (0)2 8224 ext 4780 rita.mazza@humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, MI, Italy, 20089
Contact: Armando Santoro, MD    +39 (0)2 8224 ext 4080    armando.santoro@humanitas.it   
Contact: Rita Mazza, MD    +39 (0)2 8224 ext 4780    rita.mazza@humanitas.it   
Principal Investigator: Armando Santoro, MD         
Sub-Investigator: Rita Mazza, MD         
Sponsors and Collaborators
Armando Santoro, MD
Investigators
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01884441     History of Changes
Other Study ID Numbers: ONC-2010-002
2010-022169-91 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by Armando Santoro, MD, Istituto Clinico Humanitas:
Hodgkin
Lymphoma
refractory
relapsed

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Bendamustine Hydrochloride
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators