Hodgkin's LymphomaPhase 2NCT01884441
Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients
A Phase 2 study testing Bendamustine, Gemcitabine and Vinorelbine in people with Hodgkin's Lymphoma, run by Armando Santoro, MD at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Bendamustine, Gemcitabine and Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, MI, 20089
Armando Santoro, MD, +39 (0)2 8224 ext. 4080, armando.santoro@humanitas.it
Rita Mazza, MD, +39 (0)2 8224 ext. 4780, rita.mazza@humanitas.it
About this study
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
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).
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Bendamustine, Gemcitabine, Vinorelbine
- Keywords
- Hodgkin, Lymphoma, refractory, relapsed
- Medical subject headings
- Hodgkin Disease, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustin
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
GemcitabineDrug
Also called Gemzar
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
VinorelbineDrug
Also called Navelbine
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| BeGEV | Experimental | Bendamustine, Gemcitabine and Vinorelbine (BeGEV) Receives: Drug: Bendamustine; Drug: Gemcitabine; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
overall response rate
To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)).
Measured: 3 months
mobilization potential of the combination
To evaluate the mobilization potential of BeGEV.
Measured: 3 months
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.
Measured: 3 months
Progression free survival (PFS), Overall Survival (OS).
Progression free survival and overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armando Santoro, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Santoro, MD, Istituto Clinico Humanitas
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884441
- Sponsor's protocol ID
- ONC-2010-002
- Other IDs
- 2010-022169-91
- Status last verified
- Jan 2014
- First submitted
- 27 May 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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 31935284Santoro 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01884441
- Acronym / sponsor ID
- ONC-2010-002
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin, Lymphoma, refractory, relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Armando Santoro, MDUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BeGEV | Experimental | Drug: Bendamustine, Drug: Gemcitabine, Drug: VinorelbineBendamustine, Gemcitabine and Vinorelbine (BeGEV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BendamustineAlso: RibomustinSchedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles | Drug | BeGEV |
| GemcitabineAlso: GemzarDay 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles | Drug | BeGEV |
| VinorelbineAlso: NavelbineDay 1 Vinorelbine 20mg/mq for a maximum of 4 cycles | Drug | BeGEV |
Primary outcome
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.
4 secondary outcomes
overall response rate
Time frame: 3 months
mobilization potential of the combination
Time frame: 3 months
toxicity of the combination
Time frame: 3 months
Progression free survival (PFS), Overall Survival (OS).
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Derived from this study: PubMed 31935284Santoro 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.
- Derived from this study: PubMed 27382096Santoro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine, Gemcitabine and Vinorelbine in people with Hodgkin's Lymphoma, run by Armando Santoro, MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armando Santoro, MD (+39 (0)2 8224 ext. 4080, armando.santoro@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.