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)

March 31, 2023 updated by: Polish Lymphoma Research Group

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)

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.

Study Overview

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

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bydgoszcz, Poland, 85-796
        • Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
      • Gdańsk, Poland, 80-952
        • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o.
      • Gliwice, Poland, 44-102
        • Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
      • Katowice, Poland, 40-027
        • Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
      • Kraków, Poland, 30-001
        • Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
      • Lublin, Poland, 20-081
        • Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
      • Olsztyn, Poland, 10-228
        • Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
      • Opole, Poland, 45-372
        • Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu
      • Tomaszów Mazowiecki, Poland, 97-200
        • NU-MED Centrum Diagnostyki i Terapii Onkologicznej
      • Warszawa, Poland, 02-781
        • Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie
      • Warszawa, Poland, 04-141
        • Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
      • Wrocław, Poland, 50-369
        • Samodzielny Publiczny Szpital Kliniczny Nr 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Treanda
Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
Other Names:
  • Gemzar
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:

  • 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

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:
  • ASCT

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)
CR (complete response) + PR (partial response)
Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
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.
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.
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).
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)
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).
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.
24 months from the start of BGD treatment
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.
Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Sebastian Giebel, Prof., PLRG's Chairman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 30, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

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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