The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD
NCT ID: NCT03615664
Last Updated: 2025-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2017-11-06
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BGD therapy
Bendamustine, Gemcitabine, Dexamethasone
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
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
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.
Interventions
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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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Polish Lymphoma Research Group
NETWORK
Responsible Party
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Principal Investigators
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Sebastian Giebel, Prof.
Role: STUDY_DIRECTOR
PLRG's Chairman
Locations
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Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
Bydgoszcz, , Poland
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, , Poland
Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach
Gliwice, , Poland
Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego
Katowice, , Poland
Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera
Krakow, , Poland
Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, , Poland
Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii
Olsztyn, , Poland
Oddział 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. Skłodowskiej-Curie
Warsaw, , Poland
Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Wroclaw, , Poland
Countries
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Other Identifiers
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PLRG-HL1
Identifier Type: -
Identifier Source: org_study_id
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