Clinical trial NCT03615664: The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Lymphoma
Immunochemotherapy
Salvage therapy
Bendamustine
Gemcitabine
Dexamethasone
Hodgkin's Lymphoma
ASCT
Lead sponsor: Polish Lymphoma Research Group
Sponsor class: NETWORK
First posted: 2018-08-06
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ORR (overall response rate)
timeFrame: Evaluated at the end of Cycle 2 of BGD (every cycle is 21-28 days)
measure: PFS (progression-free survival)
timeFrame: 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:
measure: OS (overall survival)
timeFrame: 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).
measure: OMRR (overall metabolic response rate)
timeFrame: 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).
measure: BGD tolerability assessment.
timeFrame: 24 months from the start of BGD treatment
measure: MR (mobilization rate)
timeFrame: Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
city: Gdańsk
country: Poland
facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Gliwice
country: Poland
facility: Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
city: Katowice
country: Poland
facility: Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
city: Kraków
country: Poland
facility: Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
city: Lublin
country: Poland
facility: Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
city: Olsztyn
country: Poland
facility: Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
city: Opole
country: Poland
facility: Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu
city: Tomaszów Mazowiecki
country: Poland
facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie
city: Warszawa
country: Poland
facility: Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
city: Wrocław
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
Study officials:
affiliation: PLRG's Chairman
name: Sebastian Giebel, Prof.
role: STUDY_DIRECTOR
References: