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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 (BURGUND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03615664
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Polish Lymphoma Research Group

Brief Summary:
The objective of the study is evaluation of efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) salvage therapy with autologus stem cell transplantation (ASCT) consolidation in advanced classical Hodgkin lymphoma patients not responding to ABVD therapy.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: Bendamustine Drug: Gemcitabine Drug: Dexamethasone Diagnostic Test: PET/CT Procedure: Autologous Stem Cell Transplant Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : May 6, 2021
Estimated Study Completion Date : May 6, 2021

Arm Intervention/treatment
Experimental: BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
Drug: Bendamustine
Bendamustine (B) 90 mg/m2 i.v. day 1, 2
Other Name: Treanda

Drug: Gemcitabine
Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
Other Name: Gemzar

Drug: Dexamethasone
Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4

Diagnostic Test: PET/CT

PET scan/CT must be performed after first 2 courses of BGD treatment. Results evaluation:

  • in case of a CMR/CR or PMR/PR, ASCT must be performed within 3 months after the end of BGD treatment
  • in case of SMD - exclusion from the trial
  • in case of PMD - exclusion from the trial

Procedure: Autologous Stem Cell Transplant

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 Name: ASCT

Primary Outcome Measures :
  1. ORR (overall response rate) [ Time Frame: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days) ]
    CR (complete response) + PR (partial response)

  2. 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 ]
    Staying free of disease progression.

Secondary Outcome Measures :
  1. 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.

  2. 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). ]
    OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)

  3. BGD tolerability assessment. [ Time Frame: 24 months from the start of BGD treatment ]
    Number of participants with treatment-related adverse events and serious adverse events.

  4. 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). ]
    Evaluation of stem cells mobilization efficacy in patients on BGD regimen.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03615664

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Contact: Jan M Zaucha, Prof. 699 84 38 ext +48 58
Contact: Jan Walewski, Prof. 546 22 23 ext +48 22

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Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka Recruiting
Bydgoszcz, Poland, 85-796
Contact: Ewa Chmielowska, PhD   
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne Recruiting
Gdańsk, Poland, 80-952
Contact: Michał Taszner, PhD   
Szpitale Pomorskie Sp. z o.o. Recruiting
Gdynia, Poland, 81-519
Contact: Wanda Knopińska-Posłuszny, PhD   
Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach Recruiting
Gliwice, Poland, 44-102
Contact: Jacek Najda, PhD         
Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego Recruiting
Katowice, Poland, 40-027
Contact: Grzegorz Helbig, Prof.         
Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera Recruiting
Kraków, Poland, 30-001
Contact: Małgorzata Raźny, PhD   
Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1 Recruiting
Lublin, Poland, 20-081
Contact: Iwona Hus, Prof.   
Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii Recruiting
Olsztyn, Poland, 10-228
Contact: Janusz Hałka, PhD         
Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu Recruiting
Opole, Poland, 45-372
Contact: Dariusz Woszczyk, PhD   
NU-MED Centrum Diagnostyki i Terapii Onkologicznej Recruiting
Tomaszów Mazowiecki, Poland, 97-200
Contact: Ewa Chmielowska, PhD   
Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie Recruiting
Warszawa, Poland, 02-781
Contact: Ewa Paszkiewicz-Kozik, PhD   
Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny Recruiting
Warszawa, Poland, 04-141
Contact: Edyta Subocz, PhD   
Samodzielny Publiczny Szpital Kliniczny nr 1 Recruiting
Wrocław, Poland, 50-369
Contact: Tomasz Wróbel, Prof.   
Sponsors and Collaborators
Polish Lymphoma Research Group
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Study Director: Sebastian Giebel, Prof. PLRG's Chairman

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Responsible Party: Polish Lymphoma Research Group Identifier: NCT03615664     History of Changes
Other Study ID Numbers: PLRG-HL1
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Polish Lymphoma Research Group:
Salvage therapy
Hodgkin's Lymphoma

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Bendamustine Hydrochloride
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents