Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
NCT ID: NCT01884441
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
59 participants
INTERVENTIONAL
2011-07-31
2016-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BeGEV
Bendamustine, Gemcitabine and Vinorelbine (BeGEV)
Bendamustine
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
Gemcitabine
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
Vinorelbine
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
Interventions
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Bendamustine
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
Gemcitabine
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
Vinorelbine
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Armando Santoro, MD
OTHER
Responsible Party
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Armando Santoro, MD
MD
Principal Investigators
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Armando Santoro, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2010-022169-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONC-2010-002
Identifier Type: -
Identifier Source: org_study_id
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