- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03615664
The Efficacy of Bendamustine, Gemcytabine, Dexamethasone Salvage Chemotherapy With Autologous Stem Cell Transplantation (BURGUND) Consolidation in Advanced Classical Hodgkin Lymphoma Patients Not Responding to ABVD Therapy (BURGUND)
The Efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) Salvage Chemotherapy With Autologous Stem Cell Transplantation (ASCT) Consolidation in Advanced Classical Hodgkin Lymphoma Patients Not Responding to ABVD Therapy- Multicentre Phase II Clinical Study (PLRG-HL1/BURGUND)
Study Overview
Status
Conditions
Detailed Description
Treatment regimen:
Bendamustine (B) 90 mg/m2 iv day 1, 2 Gemcytabine (G) 800 mg/m2 iv day 1, 4 Dexamethasone (D) 40 mg iv/po day 1,2,3,4
Course of treatment every 21-28 days, 4 courses of treatment max; next round of treatment may be given if ANC>1000/μl and PLT>75000/μl. Up to 7-day delay is permitted.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jan M Zaucha, Prof.
- Phone Number: +48 58 699 84 38
- Email: jzaucha@gumed.edu.pl
Study Contact Backup
- Name: Jan Walewski, Prof.
- Phone Number: +48 22 546 22 23
- Email: walewski@coi.waw.pl
Study Locations
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Bydgoszcz, Poland, 85-796
- Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
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Gdańsk, Poland, 80-952
- Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
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Gdynia, Poland, 81-519
- Szpitale Pomorskie Sp. z o.o.
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Gliwice, Poland, 44-102
- Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
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Katowice, Poland, 40-027
- Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
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Kraków, Poland, 30-001
- Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
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Lublin, Poland, 20-081
- Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
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Olsztyn, Poland, 10-228
- Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
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Opole, Poland, 45-372
- Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu
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Tomaszów Mazowiecki, Poland, 97-200
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej
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Warszawa, Poland, 02-781
- Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie
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Warszawa, Poland, 04-141
- Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
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Wrocław, Poland, 50-369
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed Classical Hodgkin's Lymphoma treated with ABVD regimen with PET scan/CT performed before, during and after treatment, and also one of the following:
- positive result (Deauville 4 and 5) of early PET scan after 2 ABVD courses
- disease progression or relapse after first-line ABVD treatment or ABVD and radiotherapy combination treatment
- No contraindications for salvage chemotherapy and ASCT
- At least one measurable malignancy
- ECOG performance status ≤ 3
- Written signed and dated informed consent prior to any study procedures being performed
Exclusion Criteria:
- Non-Classical Hodgkin's Lymphoma
- Other than ABVD first-line treatment, preceding patient's inclusion
- Lack of PET scans performed in accordance with inclusin criteria during ABVD treatment
- Transformation of Hodgkin's Lymphoma
- Central Nervous System (CNS) Metastases
- Contraindications for ASCT or lack of patient's consens for the procedure
- Second malignancy - active or cured less than 5 years prior
- Uncontrolled diabetes
- Hepatic impairment (bilirubin concentration ≥ 1.5 x ULN, SGOT > 5 x ULN), if non-realted to the lymphoma or Gilbert's syndrome
- HIV infection
- Active HBV or HCV infection. Subjects who have had Hepatitis B and are abHBC positive, need to undergo HBV DNA test using a Polymerase Chain Reaction (PCR) technique and be applied appropriate preventive treatment.
- Pregnancy or lactation
- Hypersensitivity to any of the drugs
- Lack of written informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
|
Bendamustine (B) 90 mg/m2 i.v.
day 1, 2
Other Names:
Gemcitabine (G) 800 mg/m2 i.v.
day 1, 4
Other Names:
Dexamethasone (D) 40 mg i.v./p.o.
day 1,2,3,4
PET scan/CT must be performed after first 2 courses of BGD treatment. Results evaluation:
Must be performed within 3 months after the end of BGD treatment. When it is not possible to perform ASCT, despite CMR or PMR response, within 3 months after second course of BGD treatment, it is permissible to extend the therapy up to 4 cycles. PET scan/CT must be repeated before performing ASCT.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR (overall response rate)
Time Frame: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
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CR (complete response) + PR (partial response)
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Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
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PFS (progression-free survival)
Time Frame: Time measured from date of of Cycle 2 of BGD treatment (every cycle is 21-28 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
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Staying free of disease progression.
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Time measured from date of of Cycle 2 of BGD treatment (every cycle is 21-28 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS (overall survival)
Time Frame: Time measured from Day 1 of Cycle 1 of BGD treatment (every cycle is 21-28 days) until the date of death from any cause, assessed up to 24 months (measured for patients that have undergone ASCT after BGD tratment).
|
The length of time from the start of treatment, that patients diagnosed with the disease are still alive.
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Time measured from Day 1 of Cycle 1 of BGD treatment (every cycle is 21-28 days) until the date of death from any cause, assessed up to 24 months (measured for patients that have undergone ASCT after BGD tratment).
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OMRR (overall metabolic response rate)
Time Frame: Evaluated a the end of Cycle 2 of BGD treatment (every cycle is 21-28 days) and after ASCT (up to 150 days after Day 1 of Cycle 1 of BGD treatment).
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OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)
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Evaluated a the end of Cycle 2 of BGD treatment (every cycle is 21-28 days) and after ASCT (up to 150 days after Day 1 of Cycle 1 of BGD treatment).
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BGD tolerability assessment.
Time Frame: 24 months from the start of BGD treatment
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Number of participants with treatment-related adverse events and serious adverse events.
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24 months from the start of BGD treatment
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MR (mobilization rate)
Time Frame: Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).
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Evaluation of stem cells mobilization efficacy in patients on BGD regimen.
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Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sebastian Giebel, Prof., PLRG's Chairman
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Gemcitabine
- Dexamethasone
- Bendamustine Hydrochloride
Other Study ID Numbers
- PLRG-HL1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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