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

Phase 2

Completed

• Conditions: Hodgkin's Lymphoma
• Interventions: Drug: Bendamustine; Drug: Gemcitabine; Drug: Dexamethasone; Diagnostic Test: PET/CT; Procedure: Autologous Stem Cell Transplant

• Registration Number: NCT03615664
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-06
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BGD therapy	Gemcitabine	Bendamustine, Gemcitabine, Dexamethasone
BGD therapy	Bendamustine	Bendamustine, Gemcitabine, Dexamethasone
BGD therapy	Dexamethasone	Bendamustine, Gemcitabine, Dexamethasone
BGD therapy	PET/CT	Bendamustine, Gemcitabine, Dexamethasone
BGD therapy	Autologous Stem Cell Transplant	Bendamustine, Gemcitabine, Dexamethasone

Primary Outcome Measures

Name	Time	Method
PFS (progression-free survival)	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.
ORR (overall response rate)	Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)	CR (complete response) + PR (partial response)

Secondary Outcome Measures

Name	Time	Method
OMRR (overall metabolic response rate)	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)
MR (mobilization rate)	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.
BGD tolerability assessment.	24 months from the start of BGD treatment	Number of participants with treatment-related adverse events and serious adverse events.
OS (overall survival)	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.

Trial Locations

Locations (13)

Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdańsk, Poland

Szpitale Pomorskie Sp. z o.o.; 🇵🇱 Gdynia, Poland

Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego; 🇵🇱 Katowice, Poland

Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu; 🇵🇱 Opole, Poland

Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie; 🇵🇱 Warszawa, Poland

Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach; 🇵🇱 Gliwice, Poland

Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1; 🇵🇱 Lublin, Poland

Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera; 🇵🇱 Kraków, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1; 🇵🇱 Wrocław, Poland

Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka; 🇵🇱 Bydgoszcz, Poland

NU-MED Centrum Diagnostyki i Terapii Onkologicznej; 🇵🇱 Tomaszów Mazowiecki, Poland

Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii; 🇵🇱 Olsztyn, Poland

Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Poland