Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed Hodgkin's Lymphoma

NCT00025636 | Unknown Phase 3

• 4 other identifiers: CDR0000068981GHSG-HD-R2EBMT-GHSG-HD-R2EORTC-20011
• Study Type: interventional
• Target: 220
• Locations: 8 countries
• Sites: 44

Brief Summary

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.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

• Efficacy at 3 months

• Toxicity at 3 months

Secondary Outcomes (3)

• Complete remission at 3 months

• Relapse-free survival at 3 months

• Overall survival at 3 months

Interventions

filgrastim BIOLOGICAL

carmustine DRUG

cisplatin DRUG

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide DRUG

melphalan DRUG

methotrexate DRUG

vincristine sulfate DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * Early or late first relapse * Complete or partial remission for at least 3 months after completion of prior COPP/ABVD, COPP/ABV/IMEP, MOPP/ABV, ABVD, BEACOPP, or other polychemotherapy regimen with or without radiotherapy * No prior salvage therapy OR * Second relapse * Any prior salvage therapy * No prior high-dose chemotherapy PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * Karnofsky 70-100% OR * ECOG 0-2 Life expectancy: * More than 3 months with treatment Hematopoietic: * Absolute neutrophil count at least 2,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncontrolled hypertension (diastolic blood pressure greater than 115 mm Hg) * No unstable angina * No New York Heart Association class III or IV heart disease (congestive heart failure) * No myocardial infarction within the past 6 months * No uncontrolled atrial or ventricular cardiac arrhythmias Pulmonary: * No chronic pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active infection * No poorly controlled diabetes * No cerebral disorder * No other concurrent malignancy except adequately treated basal cell skin cancer or cervical intraepithelial neoplasia * No significant non-malignant disease * No psychiatric, addictive, or other disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * At least 6 months since prior coronary angioplasty * No other concurrent investigational drugs * No concurrent non-steroidal anti-inflammatory drugs, salicylate, sulfonamide, trimethoprim, allopurinol, aminoglycoside, amoxicillin, or probenecid during high-dose methotrexate administration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German Hodgkin's Lymphoma Study Group: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• EBMT Solid Tumors Working Party: collaborator

Study Sites (44)

Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Algemeen Ziekenhuis Sint Lucas

Ghent, B-9000, Belgium

Location

University Hospital Rebro

Zagreb, 10000, Croatia

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, D-12200, Germany

Location

Charite - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Medizinische Poliklinik

Bonn, D-53111, Germany

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Staedtisches Klinikum Dessau

Dessau, D-06822, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Evangelisches Krankenhaus Essen Werden

Essen, D-45239, Germany

Location

Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17475, Germany

Location

Martin Luther Universitaet

Halle, D-06120, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, D-20246, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, DOH-59063, Germany

Location

Krankenhaus Siloah - Medizinische Klinik II

Hanover, D-30449, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Medizinische Universitaetsklinik und Poliklinik

Heidelberg, 69115, Germany

Location

St. Bernward Krankenhaus

Hildeshem, D-31134, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, D-66424, Germany

Location

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

Location

Klinikum der Friedrich-Schiller Universitaet Jena

Jena, D-07740, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, D-23538, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Diakonie Klinikum Stuttgart

Stuttgart, D-70176, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Maxima Medisch Centrum - Veldhoven

Veldhoven, 5500 MB, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, P-3001-301, Portugal

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28327958 DERIVED

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Filgrastim; Carmustine; Cisplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Etoposide; Melphalan; Methotrexate; Vincristine; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Glucosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Last Updated: September 17, 2013

Record last verified: 2007-06

Locations

BE (4); NL (8); PL (1); CR (1); PT (1); DE (27); DK (1); CH (1)