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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGD therapy | Experimental | Bendamustine, Gemcitabine, Dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | Bendamustine (B) 90 mg/m2 i.v. day 1, 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| OS (overall survival) | The length of time from the start of treatment, that patients diagnosed with the disease are still alive. | 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). |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Giebel, Prof. | PLRG's Chairman | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oddział Kliniczny Onkologii, Centrum Onkologii im. Prof. F. Łukaszczyka | Bydgoszcz | 85-796 | Poland | |||
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| Gemcitabine | Drug | Gemcitabine (G) 800 mg/m2 i.v. day 1, 4 |
|
|
| Dexamethasone | Drug | Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4 |
|
| PET/CT | Diagnostic Test | PET scan/CT must be performed after first 2 courses of BGD treatment. Results evaluation:
|
|
| 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. |
|
|
| OMRR (overall metabolic response rate) | OMRR= CMR (complete metabolic response) + PMR (partial metabolic response) | 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. | 24 months from the start of BGD treatment |
| MR (mobilization rate) | Evaluation of stem cells mobilization efficacy in patients on BGD regimen. | Evaluated after the end of Cycle 2 of BGD (every cycle is 21-28 days), before tranplantation (up to Day 150 of treatment). |
| Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne |
| Gdansk |
| 80-952 |
| Poland |
| Szpitale Pomorskie Sp. z o.o. | Gdynia | 81-519 | Poland |
| Centrum Onkologii - Instytut im. M. Skłodowskiej-Curie, Oddział w Gliwicach | Gliwice | 44-102 | Poland |
| Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. A.Mielęckiego | Katowice | 40-027 | Poland |
| Oddział Hematologii, Szpital Specjalistyczny im. Rydygiera | Krakow | 30-001 | Poland |
| Klinika Hematoonkologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny nr 1 | Lublin | 20-081 | Poland |
| Oddział Hematologii, Samodzielny Publiczny ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii | Olsztyn | 10-228 | Poland |
| Oddział Hematologii i Onkologii Hematologicznej, Szpital Wojewódzki w Opolu | Opole | 45-372 | Poland |
| NU-MED Centrum Diagnostyki i Terapii Onkologicznej | Tomaszów Mazowiecki | 97-200 | Poland |
| Centrum Onkologii-Instytut im. M. Skłodowskiej-Curie | Warsaw | 02-781 | Poland |
| Klinika Chorób Wewnętrznych i Hematologii, Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 | Wroclaw | 50-369 | Poland |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000093542 | Gemcitabine |
| D003907 | Dexamethasone |
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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