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Hodgkin's LymphomaPhase 2BURGUNDNCT03615664

The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD

A Phase 2 study testing Bendamustine, Gemcitabine and Dexamethasone in people with Hodgkin's Lymphoma, run by Polish Lymphoma Research Group at 13 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
Bendamustine, Gemcitabine and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
13 sitesPoland
Study dates
6 Nov 2017to 31 Dec 2024
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Poland13 sites

  • Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka

    Bydgoszcz, 85-796

  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81-519

  • Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach

    Gliwice, 44-102

  • Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego

    Katowice, 40-027

  • Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera

    Krakow, 30-001

  • Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1

    Lublin, 20-081

  • Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu

    Opole, 45-372

  • NU-MED Centrum Diagnostyki i Terapii Onkologicznej

    Tomaszów Mazowiecki, 97-200

  • Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie

    Warsaw, 02-781

  • Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny

    Warsaw, 04-141

  • Samodzielny Publiczny Szpital Kliniczny nr 1

    Wroclaw, 50-369

Other trials in Poland

About this study

Official title: The Efficacy of Bendamustine, Gemcytabine, Dexamethasone (BGD) Salvage Chemotherapy With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD - Multicentre Phase II Clinical Study - PLRG-HL1

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.

Read the 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.

Being tested
Bendamustine, Gemcitabine, Dexamethasone, PET/CT, Autologous Stem Cell Transplant
Keywords
Lymphoma, Immunochemotherapy, Salvage therapy, Bendamustine, Gemcitabine, Dexamethasone, Hodgkin's Lymphoma, ASCT
Medical subject headings
Hodgkin Disease, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BendamustineDrug

    Also called Treanda

    Bendamustine (B) 90 mg/m2 i.v. day 1, 2

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine (G) 800 mg/m2 i.v. day 1, 4

  • DexamethasoneDrug

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

  • PET/CTDiagnostic test

    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

  • Autologous Stem Cell TransplantProcedure or surgery

    Also called ASCT

    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.

Study groups in NCT03615664
Study groupRoleWhat they receive
BGD therapyExperimentalBendamustine, Gemcitabine, Dexamethasone
Receives: Drug: Bendamustine; Drug: Gemcitabine; Drug: Dexamethasone; Diagnostic Test: PET/CT; Procedure: Autologous Stem Cell Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR (overall response rate)

    CR (complete response) + PR (partial response)

    Measured: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)

  2. PFS (progression-free survival)

    Staying free of disease progression.

    Measured: 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 outcomes (4)

  1. OS (overall survival)

    The length of time from the start of treatment, that patients diagnosed with the disease are still alive.

    Measured: 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).

  2. OMRR (overall metabolic response rate)

    OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)

    Measured: 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).

  3. BGD tolerability assessment.

    Number of participants with treatment-related adverse events and serious adverse events.

    Measured: 24 months from the start of BGD treatment

  4. MR (mobilization rate)

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

    Measured: Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start6 Nov 2017
  3. Primary completion30 Nov 2024
  4. Study completion31 Dec 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615664
Sponsor's protocol ID
PLRG-HL1
Acronym
BURGUND
Status last verified
Jan 2025
First submitted
19 Jul 2018
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine, Gemcitabine and Dexamethasone in people with Hodgkin's Lymphoma, run by Polish Lymphoma Research Group at 13 sites in Poland.

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 7 inclusion and 14 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

ORR (overall response rate) (time frame: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)). The study lists 2 primary outcomes in all. 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 NCT03615664.

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 16 Jan 2025.

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