Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GHSG-HD-R2 | |||
| EBMT-GHSG-HD-R2 | |||
| EORTC-20011 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
| EBMT Solid Tumors Working Party | OTHER |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, type of relapse (early first relapse [remission duration 3-12 months] vs late first relapse [remission duration more than 12 months] vs second relapse without prior high-dose chemotherapy salvage [remission duration after salvage at least 3 months]), disease status at relapse (stage I or II vs stage III or IV), age (18 to 49 vs 50 to 60), and response after 2 courses of study induction chemotherapy (complete remission vs partial remission vs no change).
All patients receive induction chemotherapy comprising dexamethasone IV over 30 minutes on days 1-4 and 15-18, cisplatin IV continuously over 24 hours on days 1 and 15, cytarabine IV over 3 hours every 12 hours on days 2 and 16, and filgrastim (G-CSF) subcutaneously (SC) once daily on days 5-12 and days 19-26. Patients with complete remission (CR), unconfirmed CR, partial remission, or no change are randomized to one of two treatment arms.
Patients with residual lymphoma at 100 days after completion of BEAM chemotherapy may receive radiotherapy.
Patients are followed at 100 days after PBSC transplantation, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 220 patients (110 per treatment arm) will be accrued for this study within 5 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| carmustine | Drug | |||
| cisplatin | Drug | |||
| cyclophosphamide | Drug | |||
| cytarabine | Drug | |||
| dexamethasone | Drug | |||
| etoposide | Drug | |||
| melphalan |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy at 3 months | ||
| Toxicity at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission at 3 months | ||
| Relapse-free survival at 3 months | ||
| Overall survival at 3 months |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma
Early or late first relapse
Second relapse
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Engert, MD | Medizinische Universitaetsklinik I at the University of Cologne | |
| J. W. Baars, MD, PhD | The Netherlands Cancer Institute | |
| Norbert Schmitz, MD, PhD | Asklepios Klinik St. Georg |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Netwerk Antwerpen Middelheim | Antwerp | 2020 | Belgium | |||
| Institut Jules Bordet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28327958 | Derived | Brockelmann PJ, Muller H, Casasnovas O, Hutchings M, von Tresckow B, Jurgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A. Risk factors and a prognostic score for survival after autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma. Ann Oncol. 2017 Jun 1;28(6):1352-1358. doi: 10.1093/annonc/mdx072. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
| methotrexate | Drug |
| vincristine sulfate | Drug |
| bone marrow ablation with stem cell support | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| Brussels |
| 1000 |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | B-2650 | Belgium |
| Algemeen Ziekenhuis Sint Lucas | Ghent | B-9000 | Belgium |
| University Hospital Rebro | Zagreb | 10000 | Croatia |
| Rigshospitalet - Copenhagen University Hospital | Copenhagen | 2100 | Denmark |
| Charite - Campus Charite Mitte | Berlin | D-10117 | Germany |
| Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | D-12200 | Germany |
| Charite - Campus Virchow Klinikum | Berlin | D-13353 | Germany |
| Medizinische Poliklinik | Bonn | D-53111 | Germany |
| Medizinische Universitaetsklinik I at the University of Cologne | Cologne | D-50924 | Germany |
| Staedtisches Klinikum Dessau | Dessau | D-06822 | Germany |
| Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| Evangelisches Krankenhaus Essen Werden | Essen | D-45239 | Germany |
| Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet | Greifswald | D-17475 | Germany |
| Martin Luther Universitaet | Halle | D-06120 | Germany |
| Asklepios Klinik St. Georg | Hamburg | D-20099 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | D-20246 | Germany |
| Evangelische Krankenhaus Hamm | Hamm | DOH-59063 | Germany |
| Krankenhaus Siloah - Medizinische Klinik II | Hanover | D-30449 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Medizinische Universitaetsklinik und Poliklinik | Heidelberg | 69115 | Germany |
| St. Bernward Krankenhaus | Hildeshem | D-31134 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | D-66424 | Germany |
| Clinic for Bone Marrow Transplantation and Hematology and Oncology | Idar-Oberstein | D-55743 | Germany |
| Klinikum der Friedrich-Schiller Universitaet Jena | Jena | D-07740 | Germany |
| Staedtisches Klinikum Karlsruhe gGmbH | Karlsruhe | 76133 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Lübeck | D-23538 | Germany |
| Krankenhaus Muenchen Schwabing | Munich | 80804 | Germany |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | Munich | D-81377 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
| Diakonie Klinikum Stuttgart | Stuttgart | D-70176 | Germany |
| Dr. Horst-Schmidt-Kliniken | Wiesbaden | D-65199 | Germany |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 HA | Netherlands |
| Academisch Medisch Centrum at University of Amsterdam | Amsterdam | 1105 AZ | Netherlands |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Leiden University Medical Center | Leiden | 2300 RC | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6202 AZ | Netherlands |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Nijmegen | NL-6500 HB | Netherlands |
| Maxima Medisch Centrum - Veldhoven | Veldhoven | 5500 MB | Netherlands |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Hospitais da Universidade de Coimbra (HUC) | Coimbra | P-3001-301 | Portugal |
| UniversitaetsSpital Zuerich | Zurich | CH-8091 | Switzerland |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002330 | Carmustine |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D008727 | Methotrexate |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided