Classical Hodgkin Lymphoma RelapsedPhase 3BEGEVNCT07450508
Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma
A Phase 3 study testing BEGEV (Bendamustine, Gemcitabine,Vinorelbine) and GDP(Gemcitabine, Dexamethasone and Cisplatin) in people with Classical Hodgkin Lymphoma Relapsed, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Classical Hodgkin Lymphoma Relapsed
- What is being tested?
- BEGEV (Bendamustine, Gemcitabine,Vinorelbine) and GDP(Gemcitabine, Dexamethasone and Cisplatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2024to 1 Feb 2026
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary refractory classical Hodgkin lymphoma Relapsed classical Hodgkin lymphoma Age 18 years old or more Both genders Eligible to receive the chemotherapeutic protocol.
Who cannot join
- Eastern Cooperative Oncology Group(ECOG) performance status less than 2. Pregnancy. Second cancers. Chronic kidney disease End stage renal disease Liver cell failure HIV HCV HBV Autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bendamustine, Gemcitabine and Vinorelbine (BEGEV) Chemotherapeutic Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma
The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma.
Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year
Read the detailed description
Patients with primary refractory and relapsed classical Hodgkin lymphoma attended the medical oncology department at the National Cancer Institute, Cairo University, Egypt during the period from April, 2024 to October, 2024 were randomly assigned in the 2 treatment groups using online random number generator.
Exclusion criteria include age less than 18 year, Eastern Cooperative Oncology Group(ECOG) performance status less than 2, pregnancy, second cancers chronic kidney disease, end stage renal disease, liver cell failure, HIV, HCV, HBV, and autoimmune diseases.
The basic, epidemiological, clinical, laboratory, pathological, and radiological data, and complete staging was recorded at the baseline.
The BEGEV regimen was administered as follows: gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4, vinorelbine 20 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 2 and 3.
The GDP regimen was administered as follows: Gemcitabine 1000 mg/m2 days 1 and 8, dexamethasone 20 mg/m2 days 1-4 and days 11-14 and cisplatin 25 mg/m2 days 1-3.
Cycles were repeated every 21 days for a total of 4 cycles, guided by the clinical situation.
Side effects were reported according to National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly.
Interim evaluation was done after 3 cycles and response was reported according to the International Workshop for Response Criteria for non-Hodgkin lymphomas.
Patients who attained at least partial response were sent for autologous stem cell transplantation and the same evaluation was repeated post-transplant.
Patients was followed every 3 months for a total of 1 year and relapse, mortality, progression free survival, disease free survival, and overall survival, were recorded.
Sample size calculation:
A study conducted by Stefoni et al. (2023) assessed the effectiveness of BEGEV regimen and reported that the overall response rate was 76.7%, another study by Rybka et al. (2015) assessed the effectiveness of GDP regimen and reported that the overall response rate was 31% in Hodgkin lymphoma patients. A total sample size of 44 (22 in each group) was needed for this study with alpha 5% and power 80%. Sample size calculation was done using MedCalc program version 18.2.1.
- Conditions
- Classical Hodgkin Lymphoma Relapsed
- Being tested
- BEGEV (Bendamustine, Gemcitabine,Vinorelbine), GDP(Gemcitabine, Dexamethasone and Cisplatin)
- Keywords
- BEGEV, GDP, Refractory classical Hodgkin Lymphoma, Relapsed classical Hodgkin Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEGEV (Bendamustine, Gemcitabine,Vinorelbine)Combination product
Gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4. Vinorelbine 20 mg/m2 on day 1. Bendamustine 90 mg/m2 on days 2 and 3.
GDP(Gemcitabine, Dexamethasone and Cisplatin)Combination product
Gemcitabine 1000 mg/m2 days 1 and 8. Dexamethasone 20 mg/m2 days 1-4 and days 11-14 Cisplatin 25 mg/m2 days 1-3.
| Study group | Role | What they receive |
|---|---|---|
| BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine) | Active comparator | Received the BEGEV protocol Receives: Combination Product: BEGEV (Bendamustine, Gemcitabine,Vinorelbine) |
| GDP arm (Gemcitabine,Dexamethasone,Cisplatin) | Active comparator | Received the GDP protocol Receives: Combination Product: GDP(Gemcitabine, Dexamethasone and Cisplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
According to the International Workshop for Response Criteria for non-Hodgkin lymphomas.
The response is classified as either complete response (CR), partial response (PR), stable disease(SD) or progressive disease (PD).
The sum of CR and PR is labelled as overall response rate.
Measured: Six months
Secondary outcomes (2)
Progression free survival
Calculated from the start of the intervention to the first disease progression or death
Measured: 20 months
Disease free survival
Calculated from the first documented response to the first disease relapse or death that is related to the disease or the acute toxicity of the therapy
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start30 Apr 2024
- Primary completion30 Oct 2024
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Classical Hodgkin Lymphoma RelapsedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Shaheen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450508
- Sponsor's protocol ID
- MO2404-205-001
- Acronym
- BEGEV
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1-Ansell SM. Hodgkin lymphoma: 2023 update on diagnosis, risk-stratification, and management. Am J Hematol. 2022; 97(11): 1478-1488. doi:10.1002/ajh.26717 https://onlinelibrary.wiley.com/doi/10.1002/ajh.26717 2-Ansell S.M., Radford J., Connors J.M., Długosz-Danecka M., Kim W.-S., Gallamini A., Ramchandren R., Friedberg J.W., Advani R., Hutchings M., et al. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N. Engl. J. Med. 2022; 387:310-320. doi:10.1056/NEJMoa2206125.https://pubmed.ncbi.nlm.nih.gov/35830649/ 3-Arai S, Fanale M, DeVos S, Engert A et al. Defining a Hodgkin lymphoma population for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma.2013; 54:2531-2533. https://doi.org/10.3109/10428194.2013.798868 4-Santoro A, Magagnoli M, Spina M et al. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica.2007; 92:35-41. https:// doi.org/10.3324/haematol.10661 https://pubmed.ncbi.nlm.nih.gov/17229633/ 5- Santoro A, Mazza R, Pulsoni A et al. Bendamustine in combination with gemcitabine and vinorelbine is an efective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: fnal results of a multicenter phase II study. J Clin Oncol.2016; 34:3293-3299. https://pubmed.ncbi.nlm.nih.gov/27382096/ 6- Stefoni V, Argnani L, Carella M, Casadei B, Morigi A, Lolli G, Broccoli A, Pellegrini C, Nanni L, Coppola PE, Zinzani PL. BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma: a real-life experience. J Cancer Res Clin Oncol. 2023 Mar;149(3):1043-1047. doi: 10.1007/s00432-022-03955-w. Epub 2022 Mar 3. PMID: 35239000; PMCID: PMC9984336. https://pubmed.ncbi.nlm.nih.gov/35239000/ 7- Rybka J, Jurczak W, Giza A, Paszkiewicz-Kozik E, Kumiega B, Drozd-Sokołowska J, Butrym A, Kuliczkowski K, Wróbel T. Gemcitabine-Based Treatment in Poor-Prognosis Patient
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bendamustine, Gemcitabine and Vinorelbine (BEGEV) Chemotherapeutic Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07450508
- Acronym / sponsor ID
- BEGEV / MO2404-205-001
- Conditions
- Classical Hodgkin Lymphoma Relapsed
- Keywords
- BEGEV, GDP, Refractory classical Hodgkin Lymphoma, Relapsed classical Hodgkin Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- 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.
The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma.
Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year
Detailed description
Patients with primary refractory and relapsed classical Hodgkin lymphoma attended the medical oncology department at the National Cancer Institute, Cairo University, Egypt during the period from April, 2024 to October, 2024 were randomly assigned in the 2 treatment groups using online random number generator.
Exclusion criteria include age less than 18 year, Eastern Cooperative Oncology Group(ECOG) performance status less than 2, pregnancy, second cancers chronic kidney disease, end stage renal disease, liver cell failure, HIV, HCV, HBV, and autoimmune diseases.
The basic, epidemiological, clinical, laboratory, pathological, and radiological data, and complete staging was recorded at the baseline.
The BEGEV regimen was administered as follows: gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4, vinorelbine 20 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 2 and 3.
The GDP regimen was administered as follows: Gemcitabine 1000 mg/m2 days 1 and 8, dexamethasone 20 mg/m2 days 1-4 and days 11-14 and cisplatin 25 mg/m2 days 1-3.
Cycles were repeated every 21 days for a total of 4 cycles, guided by the clinical situation.
Side effects were reported according to National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly.
Interim evaluation was done after 3 cycles and response was reported according to the International Workshop for Response Criteria for non-Hodgkin lymphomas.
Patients who attained at least partial response were sent for autologous stem cell transplantation and the same evaluation was repeated post-transplant.
Patients was followed every 3 months for a total of 1 year and relapse, mortality, progression free survival, disease free survival, and overall survival, were recorded.
Sample size calculation:
A study conducted by Stefoni et al. (2023) assessed the effectiveness of BEGEV regimen and reported that the overall response rate was 76.7%, another study by Rybka et al. (2015) assessed the effectiveness of GDP regimen and reported that the overall response rate was 31% in Hodgkin lymphoma patients. A total sample size of 44 (22 in each group) was needed for this study with alpha 5% and power 80%. Sample size calculation was done using MedCalc program version 18.2.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine) | Active comparator | Combination Product: BEGEV (Bendamustine, Gemcitabine,Vinorelbine)Received the BEGEV protocol |
| GDP arm (Gemcitabine,Dexamethasone,Cisplatin) | Active comparator | Combination Product: GDP(Gemcitabine, Dexamethasone and Cisplatin)Received the GDP protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary refractory classical Hodgkin lymphoma Relapsed classical Hodgkin lymphoma Age 18 years old or more Both genders Eligible to receive the chemotherapeutic protocol.
Key exclusion criteria (1 listed)
- Eastern Cooperative Oncology Group(ECOG) performance status less than 2. Pregnancy. Second cancers. Chronic kidney disease End stage renal disease Liver cell failure HIV HCV HBV Autoimmune diseases
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 |
|---|---|---|
| BEGEV (Bendamustine, Gemcitabine,Vinorelbine)Gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4. Vinorelbine 20 mg/m2 on day 1. Bendamustine 90 mg/m2 on days 2 and 3. | Combination product | BEGEV arm (Bendamustine, Gemcitabine and Vinorelbine) |
| GDP(Gemcitabine, Dexamethasone and Cisplatin)Gemcitabine 1000 mg/m2 days 1 and 8. Dexamethasone 20 mg/m2 days 1-4 and days 11-14 Cisplatin 25 mg/m2 days 1-3. | Combination product | GDP arm (Gemcitabine,Dexamethasone,Cisplatin) |
Primary outcome
Overall response rate
Time frame: Six months
According to the International Workshop for Response Criteria for non-Hodgkin lymphomas. The response is classified as either complete response (CR), partial response (PR), stable disease(SD) or progressive disease (PD). The sum of CR and PR is labelled as overall response rate.
2 secondary outcomes
Progression free survival
Time frame: 20 months
Disease free survival
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background1-Ansell SM. Hodgkin lymphoma: 2023 update on diagnosis, risk-stratification, and management. Am J Hematol. 2022; 97(11): 1478-1488. doi:10.1002/ajh.26717 https://onlinelibrary.wiley.com/doi/10.1002/ajh.26717 2-Ansell S.M., Radford J., Connors J.M., Długosz-Danecka M., Kim W.-S., Gallamini A., Ramchandren R., Friedberg J.W., Advani R., Hutchings M., et al. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N. Engl. J. Med. 2022; 387:310-320. doi:10.1056/NEJMoa2206125.https://pubmed.ncbi.nlm.nih.gov/35830649/ 3-Arai S, Fanale M, DeVos S, Engert A et al. Defining a Hodgkin lymphoma population for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma.2013; 54:2531-2533. https://doi.org/10.3109/10428194.2013.798868 4-Santoro A, Magagnoli M, Spina M et al. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica.2007; 92:35-41. https:// doi.org/10.3324/haematol.10661 https://pubmed.ncbi.nlm.nih.gov/17229633/ 5- Santoro A, Mazza R, Pulsoni A et al. Bendamustine in combination with gemcitabine and vinorelbine is an efective regimen as induction chemotherapy before autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma: fnal results of a multicenter phase II study. J Clin Oncol.2016; 34:3293-3299. https://pubmed.ncbi.nlm.nih.gov/27382096/ 6- Stefoni V, Argnani L, Carella M, Casadei B, Morigi A, Lolli G, Broccoli A, Pellegrini C, Nanni L, Coppola PE, Zinzani PL. BEGEV salvage regimen in relapsed/refractory classical Hodgkin lymphoma: a real-life experience. J Cancer Res Clin Oncol. 2023 Mar;149(3):1043-1047. doi: 10.1007/s00432-022-03955-w. Epub 2022 Mar 3. PMID: 35239000; PMCID: PMC9984336. https://pubmed.ncbi.nlm.nih.gov/35239000/ 7- Rybka J, Jurczak W, Giza A, Paszkiewicz-Kozik E, Kumiega B, Drozd-Sokołowska J, Butrym A, Kuliczkowski K, Wróbel T. Gemcitabine-Based Treatment in Poor-Prognosis Patient
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BEGEV (Bendamustine, Gemcitabine,Vinorelbine) and GDP(Gemcitabine, Dexamethasone and Cisplatin) in people with Classical Hodgkin Lymphoma Relapsed, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 2026. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Six 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 NCT07450508, which also lists 1 linked publication.
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 4 Mar 2026.