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

Hodgkin's Lymphoma Clinical Trial

— BURGUND  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03615664
• Other study ID #: PLRG-HL1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 6, 2017
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Polish Lymphoma Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• Bendamustine
Bendamustine (B) 90 mg/m2 i.v. day 1, 2
• Gemcitabine
Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
• 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.

Locations

Country	Name	City	State
Poland	Oddzial Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Lukaszczyka	Bydgoszcz
Poland	Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Szpitale Pomorskie Sp. z o.o.	Gdynia
Poland	Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach	Gliwice
Poland	Oddzial Chorób Wewnetrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mieleckiego	Katowice
Poland	Oddzial Hematologii, Szpital Specjalistyczny im. Rydygiera	Kraków
Poland	Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1	Lublin
Poland	Oddzial Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii	Olsztyn
Poland	Oddzial Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu	Opole
Poland	NU-MED Centrum Diagnostyki i Terapii Onkologicznej	Tomaszów Mazowiecki
Poland	Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie	Warszawa
Poland	Klinika Chorób Wewnetrznych i Hematologii, Wojskowy Instytut Medyczny	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Polish Lymphoma Research Group

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR (overall response rate)	CR (complete response) + PR (partial response)	Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
Primary	PFS (progression-free survival)	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	OS (overall survival)	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).
Secondary	OMRR (overall metabolic response rate)	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).
Secondary	BGD tolerability assessment.	Number of participants with treatment-related adverse events and serious adverse events.	24 months from the start of BGD treatment
Secondary	MR (mobilization rate)	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).