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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Bendamustine (B) 90 mg/m2 i.v. day 1, 2
Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4
Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka
Bydgoszcz, Poland
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
ORR (overall response rate)
CR (complete response) + PR (partial response)
Time frame: 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 frame: 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
OS (overall survival)
The length of time from the start of treatment, that patients diagnosed with the disease are still alive.
Time frame: 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)
OMRR= CMR (complete metabolic response) + PMR (partial metabolic response)
Time frame: 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.
Number of participants with treatment-related adverse events and serious adverse events.
Time frame: 24 months from the start of BGD treatment
MR (mobilization rate)
Evaluation of stem cells mobilization efficacy in patients on BGD regimen.
Time frame: Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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.
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
...and 3 more locations