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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)

Primary Purpose

Hodgkin's Lymphoma

Status
Active
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Bendamustine
Gemcitabine
Dexamethasone
PET/CT
Autologous Stem Cell Transplant
Sponsored by
Polish Lymphoma Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Lymphoma, Immunochemotherapy, Salvage therapy, Bendamustine, Gemcitabine, Dexamethasone, Hodgkin's Lymphoma, ASCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
  • Szpitale Pomorskie Sp. z o.o.
  • Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
  • Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
  • Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
  • Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
  • Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
  • Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu
  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
  • Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie
  • Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
  • Samodzielny Publiczny Szpital Kliniczny nr 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BGD therapy

Arm Description

Bendamustine, Gemcitabine, Dexamethasone

Outcomes

Primary Outcome Measures

ORR (overall response rate)
CR (complete response) + PR (partial response)
PFS (progression-free survival)
Staying free of disease progression.

Secondary Outcome Measures

OS (overall survival)
The length of time from the start of treatment, that patients diagnosed with the disease are still alive.
OMRR (overall metabolic response rate)
OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)
BGD tolerability assessment.
Number of participants with treatment-related adverse events and serious adverse events.
MR (mobilization rate)
Evaluation of stem cells mobilization efficacy in patients on BGD regimen.

Full Information

First Posted
July 19, 2018
Last Updated
March 31, 2023
Sponsor
Polish Lymphoma Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT03615664
Brief Title
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
Acronym
BURGUND
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polish Lymphoma Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Lymphoma, Immunochemotherapy, Salvage therapy, Bendamustine, Gemcitabine, Dexamethasone, Hodgkin's Lymphoma, ASCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGD therapy
Arm Type
Experimental
Arm Description
Bendamustine, Gemcitabine, Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda
Intervention Description
Bendamustine (B) 90 mg/m2 i.v. day 1, 2
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplant
Other Intervention Name(s)
ASCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR (overall response rate)
Description
CR (complete response) + PR (partial response)
Time Frame
Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
Title
PFS (progression-free survival)
Description
Staying free of disease progression.
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
Secondary Outcome Measure Information:
Title
OS (overall survival)
Description
The length of time from the start of treatment, that patients diagnosed with the disease are still alive.
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).
Title
OMRR (overall metabolic response rate)
Description
OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)
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).
Title
BGD tolerability assessment.
Description
Number of participants with treatment-related adverse events and serious adverse events.
Time Frame
24 months from the start of BGD treatment
Title
MR (mobilization rate)
Description
Evaluation of stem cells mobilization efficacy in patients on BGD regimen.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Giebel, Prof.
Organizational Affiliation
PLRG's Chairman
Official's Role
Study Director
Facility Information:
Facility Name
Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Facility Name
Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
City
Kraków
ZIP/Postal Code
30-001
Country
Poland
Facility Name
Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1
City
Wrocław
ZIP/Postal Code
50-369
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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