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

NCT03615664 | Completed Phase 2 DMC

• 1 other identifier: PLRG-HL1
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 13

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.

Conditions

Hodgkin's Lymphoma

Keywords

Lymphoma; Immunochemotherapy; Salvage therapy; Bendamustine; Gemcitabine; Dexamethasone; Hodgkin's Lymphoma; ASCT

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• 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).

• 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).

• BGD tolerability assessment.

  24 months from the start of BGD treatment

• 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).

Study Arms (1)

BGD therapy

EXPERIMENTAL

Bendamustine, Gemcitabine, Dexamethasone

Drug: Bendamustine; Drug: Gemcitabine; Drug: Dexamethasone; Diagnostic Test: PET/CT; Procedure: Autologous Stem Cell Transplant

Interventions

Bendamustine DRUG

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

Also known as: Treanda

BGD therapy

Gemcitabine DRUG

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

Also known as: Gemzar

BGD therapy

Dexamethasone DRUG

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

BGD therapy

PET/CT DIAGNOSTIC_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

BGD therapy

Autologous Stem Cell Transplant PROCEDURE

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.

Also known as: ASCT

BGD therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-Classical Hodgkin's Lymphoma
• 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

Sponsors & Collaborators

• Polish Lymphoma Research Group: lead

Study Sites (13)

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

Bydgoszcz, 85-796, Poland

Location

Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Szpitale Pomorskie Sp. z o.o.

Gdynia, 81-519, Poland

Location

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

Gliwice, 44-102, Poland

Location

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

Katowice, 40-027, Poland

Location

Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera

Krakow, 30-001, Poland

Location

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

Lublin, 20-081, Poland

Location

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

Olsztyn, 10-228, Poland

Location

Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu

Opole, 45-372, Poland

Location

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, 97-200, Poland

Location

Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie

Warsaw, 02-781, Poland

Location

Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1

Wroclaw, 50-369, Poland

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Bendamustine Hydrochloride; Gemcitabine; Dexamethasone; Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Sebastian Giebel, Prof.

  PLRG's Chairman

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 6, 2018
• Study Start: November 6, 2017
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (13)