Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

NCT00012051 | Completed Phase 3

• 6 other identifiers: CKTO-2000-06CDR0000068476HOVON-44HOVON-44/CKVO-2000-06EU-20042ISRCTN95614846
• Study Type: interventional
• Target: 340
• Locations: 2 countries
• Sites: 17

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent grade 3 follicular lymphoma; recurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (2)

• Response rate

• Event-free survival

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

carmustine DRUG

cisplatin DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide DRUG

ifosfamide DRUG

melphalan DRUG

methotrexate DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL) * Diffuse large cell B-cell lymphoma * Grade III follicular center-cell lymphoma * Primary mediastinal B-cell lymphoma * CD20 positive * First relapse after doxorubicin containing regimen * Documented remission of at least 3 months after first-line chemotherapy * No Epstein-Barr virus post-transplantation lymphoproliferative disorder * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No hepatic dysfunction * Bilirubin less than 2.5 times upper limit of normal (ULN) * Transaminases less than 2.5 times ULN Renal: * No renal dysfunction * Creatinine less than 2.0 mg/dL OR * Creatinine clearance greater than 40 mL/min Cardiovascular: * No severe cardiac dysfunction * No New York Heart association class II-IV heart disease Pulmonary: * No severe pulmonary dysfunction * Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement Other: * No active uncontrolled infection * HIV negative * No intolerance to exogenous protein administration PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior immunotherapy Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since prior radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

• Commissie Voor Klinisch Toegepast Onderzoek: lead

Study Sites (17)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Meander Medisch Centrum

Amersfoort, 3816 CP, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 BE, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081HV, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Medisch Centrum Leeuwarden - Zuid

Leeuwarden, 8934 AD, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

Related Publications (1)

• Vellenga E, van Putten WL, van 't Veer MB, Zijlstra JM, Fibbe WE, van Oers MH, Verdonck LF, Wijermans PW, van Imhoff GW, Lugtenburg PJ, Huijgens PC. Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial. Blood. 2008 Jan 15;111(2):537-43. doi: 10.1182/blood-2007-08-108415. Epub 2007 Oct 30.

  PMID: 17971487 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Interventions

Filgrastim; Rituximab; Carmustine; Cisplatin; Cytarabine; Dexamethasone; Etoposide; Ifosfamide; Melphalan; Methotrexate; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

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; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum 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; Hydrocarbons; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Edo Vellenga, MD

  University Medical Center Groningen

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2000
• Study Completion: October 1, 2007
• Last Updated: August 12, 2013

Record last verified: 2007-03

Locations

BE (1); NL (16)