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Status unknownNCT01884441Updated Jan 29, 2014

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

A Phase 2 interventional study of Bendamustine and Gemcitabine in Hodgkin's Lymphoma, sponsored by Armando Santoro, MD. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-29.

Sponsored by Armando Santoro, MD · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Hodgkin's Lymphoma

Keywords

  • Hodgkin
  • Lymphoma
  • refractory
  • relapsed
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 59 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Armando Santoro, MD is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (estimated)

Study arms

  • Experimental
    BeGEV

    Bendamustine, Gemcitabine and Vinorelbine (BeGEV)

    Drug: Bendamustine · Drug: Gemcitabine · Drug: Vinorelbine

Interventions

  • DrugBendamustine

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

    Also known as: Ribomustin

  • DrugGemcitabine

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

    Also known as: Gemzar

  • DrugVinorelbine

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

    Also known as: Navelbine

06

What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. overall response rate

    To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).

    Time frame: 3 months

  2. mobilization potential of the combination

    To evaluate the mobilization potential of BeGEV.

    Time frame: 3 months

  3. toxicity of the combination

    To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0.

    Time frame: 3 months

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

    Progression free survival and overall survival

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Istituto Clinico Humanitas
    Rozzano, MI 20089, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31935284 ↗
  • 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. PubMed 27382096 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01884441
Lead sponsor
Armando Santoro, MD
Responsible party
Armando Santoro, MD (MD, Istituto Clinico Humanitas) — Sponsor-investigator
First posted
Jun 24, 2013
Start date
Jul 2011
Primary completion
Jul 2014 (estimated)
Completion
Jul 2016 (estimated)
Last update
Jan 29, 2014

Study contacts

Armando Santoro, MD
Contact
armando.santoro@humanitas.it
+39 (0)2 8224 ext. 4080
Rita Mazza, MD
Contact
rita.mazza@humanitas.it
+39 (0)2 8224 ext. 4780
Armando Santoro, MD
principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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