Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

NCT00003215 | Completed Phase 3

• 3 other identifiers: SAKK 38/97SWS-SAKK-38/97EU-97037
• Study Type: interventional
• Target: 400
• Locations: 5 countries
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; anaplastic large cell lymphoma

Interventions

filgrastim BIOLOGICAL

CHOP regimen DRUG

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

leucovorin calcium DRUG

melphalan DRUG

methotrexate DRUG

methylprednisolone DRUG

mitoxantrone hydrochloride DRUG

prednisone DRUG

therapeutic hydrocortisone DRUG

vincristine sulfate DRUG

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) * Diffuse large B-cell lymphoma * Primary mediastinal large B-cell lymphoma * Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type) * At least two of the following risk factors: * Stage III or IV * LDH greater than upper limit of normal (ULN) * ECOG 2, 3, or 4 * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * See Disease Characteristics * ECOG 0-4 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No hepatitis B or C * AST or ALT no greater than 2 times ULN\* * Bilirubin no greater than 2.34 mg/dL\* NOTE: \*Unless due to tumor involvement Renal: * Creatinine clearance at least 60 mL/min (unless due to tumor involvement) Cardiovascular: * No significant heart failure * LVEF normal * No active angina pectoris * No myocardial infarction within the past 6 months * No major ventricular arrhythmia Pulmonary: * No significant lung disorder Other: * HIV negative * No severe active acute or chronic infection * No severe psychoses * No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy) Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation) * No concurrent prophylactic radiotherapy to the brain Surgery: * Not specified

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

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (12)

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Saint Savvas Cancer Hospital of Athens

Athens, 11522, Greece

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Universitatsspital-Basel

Basel, CH-4031, Switzerland

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Ratisches Kantons und Regionalspital

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Collonge-Bellerive, CH-1245, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

Related Publications (1)

• Betticher DC, Martinelli G, Radford JA, Kaufmann M, Dyer MJ, Kaiser U, Aulitzky WE, Beck J, von Rohr A, Kovascovics T, Cogliatti SB, Cina S, Maibach R, Cerny T, Linch DC. Sequential high dose chemotherapy as initial treatment for aggressive sub-types of non-Hodgkin lymphoma: results of the international randomized phase III trial (MISTRAL). Ann Oncol. 2006 Oct;17(10):1546-52. doi: 10.1093/annonc/mdl153. Epub 2006 Aug 3.

  PMID: 16888080 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Large-Cell, Anaplastic

Interventions

Filgrastim; VAP-cyclo protocol; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Leucovorin; Melphalan; Methotrexate; Methylprednisolone; Mitoxantrone; Prednisone; Hydrocortisone; Vincristine; 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, B-Cell; Lymphoma, T-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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienediols; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; 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

• Daniel C. Betticher, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1997
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

IT (1); CH (8); DE (1); AU (1); GR (1)