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NCT00005589

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2013-04-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

Detailed Description

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OBJECTIVES:

* Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkin's lymphoma undergoing high-dose chemotherapy.
* Determine the effects of this regimen on response rate and overall survival in this patient population.
* Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients.
* Determine the safety of rituximab in the transplant setting.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to type of remission (complete vs good partial) and which remission (second vs third). Patients are randomized to one of four treatment arms.

All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 1.

Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction. For those patients receiving purging (arms I and II), rituximab is administered IV once weekly for 4 weeks.

Peripheral blood stem cells (PBSC) are collected between days 8 and 12 post induction chemotherapy. Within 4 weeks of PBSC collection, patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours on days -5 to -2, cytarabine IV over 5 minutes twice daily on days -5 to -2, and melphalan IV over 10-15 minutes on day -1. (Alternatively, high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed.) PBSC are reinfused on day 0.

Patients are further randomized to receive either rituximab maintenance or observation only. For those patients receiving maintenance (arms I and III), rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion.

Patients are followed at 30 days, 3, 6, 9, and 12 months after PBSC transplant, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 5 years.

Conditions

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Lymphoma

Keywords

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recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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filgrastim

Intervention Type BIOLOGICAL

rituximab

Intervention Type BIOLOGICAL

carmustine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

melphalan

Intervention Type DRUG

bone marrow ablation with stem cell support

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)

* No evidence of transformation to high grade or diffuse large B-cell NHL
* CD20 positive with no evidence of transformation
* Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen

* Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy
* Platelet count greater than 100,000/mm\^3 after induction chemotherapy and before randomization
* No CNS involvement

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-1

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin normal
* ALT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* Hepatitis B negative
* Hepatitis C negative

Renal:

* Creatinine no greater than 2 times ULN
* BUN no greater than 2 times ULN

Cardiovascular:

* No inadequate cardiac function

Pulmonary:

* No inadequate pulmonary function

Other:

* Not pregnant or nursing
* HIV negative
* No other uncontrolled serious medical conditions
* No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* More than 12 months since prior CD20 therapy, including rituximab
* No prior peripheral blood stem cell transplantation

Chemotherapy:

* See Disease Characteristics
* No more than 3 prior chemotherapy regimens for NHL

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to greater than 30% of bone marrow

Surgery:

* Not specified

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Ruth Pettengell, MD

Role: STUDY_CHAIR

St George's, University of London

David C. Linch

Role: STUDY_CHAIR

Middlesex Hospital

Locations

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Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Westmead Institute for Cancer Research at Westmead Hospital

Westmead, New South Wales, Australia

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Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

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Royal Adelaide Hospital Cancer Centre

Adelaide, South Australia, Australia

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Queen Elizabeth Hospital

Woodville, South Australia, Australia

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Royal Melbourne Hospital

Parkville, Victoria, Australia

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Fremantle Hospital

Fremantle, Western Australia, Australia

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Royal Perth Hospital

Perth, Western Australia, Australia

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Allgemeines Krankenhaus - Universitatskliniken

Vienna, , Austria

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Ziekenhuis Netwerk Antwerpen Middelheim

Antwerp, , Belgium

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Institut Jules Bordet

Brussels, , Belgium

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Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, , Belgium

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Universitair Ziekenhuis Gent

Ghent, , Belgium

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U.Z. Gasthuisberg

Leuven, , Belgium

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CHU Liege - Domaine Universitaire du Sart Tilman

Liège, , Belgium

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Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, , Belgium

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H. Hartziekenhuis - Roeselaere.

Roeselaere, , Belgium

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Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

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Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

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University Hospital Kralovske Vinohr

Prague, , Czechia

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Aalborg Hospital

Aalborg, , Denmark

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Rigshospitalet - Copenhagen University Hospital

Copenhagen, , Denmark

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Odense University Hospital

Odense, , Denmark

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Centre Hospitalier Regional et Universitaire d'Angers

Angers, , France

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Polyclinique Du Parc

Caen, , France

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Centre Regional Francois Baclesse

Caen, , France

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CHU de Grenoble - Hopital de la Tronche

Grenoble, , France

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Centre Leon Berard

Lyon, , France

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Polyclinique Saint Jean

Melun, , France

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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

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CHR Hotel Dieu

Nantes, , France

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Hopital Saint-Louis

Paris, , France

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CHU Pitie-Salpetriere

Paris, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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Centre Hospitalier Universitaire de Rennes

Rennes, , France

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Centre Henri Becquerel

Rouen, , France

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Centre Hospitalier Universitaire Bretonneau de Tours

Tours, , France

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Institut Gustave Roussy

Villejuif, , France

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Klinikum Augsburg

Augsburg, , Germany

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DIAKO Ev. Diakonie Krankenhaus gGmbH

Bremen, , Germany

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Universitaetsklinikum Goettingen

Göttingen, , Germany

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Asklepios Klinik St. Georg

Hamburg, , Germany

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Medical University Hospital Homburg

Homburg, , Germany

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Universitaetsklinikum des Saarlandes

Homburg, , Germany

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Klinikum Nuernberg - Klinikum Nord

Nuremberg, , Germany

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Klinikum Oldenburg

Oldenburg, , Germany

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Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, , Germany

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Chaim Sheba Medical Center

Tel Litwinsky, , Israel

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Auckland City Hospital

Auckland, , New Zealand

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Canterbury Health Laboratories

Christchurch, , New Zealand

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Waikato Hospital

Hamilton, , New Zealand

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Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

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K. Dluski Hospital-Medical Academy

Wroclaw, , Poland

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Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

Lisbon, , Portugal

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Hospital Juan Canalejo

A Coruña, , Spain

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Hospital General - Alicante

Alicante, , Spain

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Hospital de Cruces

Barakaldo Bilbao, , Spain

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Centro Medico Teknon

Barcelona, , Spain

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Hospital de la Santa Cruz i Sant Pau

Barcelona, , Spain

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Hospital Clinic de Barcelona

Barcelona, , Spain

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Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

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Hospital Universitario Puerta Del Mar

Cadiz, , Spain

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Hospital General de Castellon

Castellon, , Spain

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Hospital San Pedro de Alcantara

Cáceres, , Spain

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Hospital Virgen de la Arrixaca

El Palmar, , Spain

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Hospital de Galdakao

Galdakao Vizcaya, , Spain

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Hospital Virgen de las Nieves

Granada, , Spain

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Hospital Cuidad de Jaen

Jaén, , Spain

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Hospital de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

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Hospital de la Princesa

Madrid, , Spain

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Hospital General Universitario Gregorio Maranon

Madrid, , Spain

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Hospital Ramon y Cajal

Madrid, , Spain

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Hospital Universitario San Carlos

Madrid, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

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Hospital Universitario de Getafe

Madrid, , Spain

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Hospital General Universitario Morales Meseguer

Murcia, , Spain

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Hospital Universitario Central de Asturias

Oviedo, , Spain

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Hospital Son Dureta

Palma de Mallorca, , Spain

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Hospital Virgen de la Vega

Salamanca, , Spain

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University Hospital - Salamanca

Salamanca, , Spain

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Hospital Universitario Marques de Valdecilla

Santander, , Spain

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Hospital Universidad Virgen Del Rocio

Seville, , Spain

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Hospital Mutua de Terrassa

Terrassa, , Spain

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Hospital Clinico Universitario de Valencia

Valencia, , Spain

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Unidad De Oncol/Hemat. Hospital

Valencia, , Spain

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Complexo Hospitalario Xeral de Vigo

Vigo Pontevedra, , Spain

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Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

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Hospital Universitario Miguel Servet

Zaragoza, , Spain

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Karolinska University Hospital - Huddinge

Stockholm, , Sweden

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Kantonsspital Bruderholz

Bruderholz, , Switzerland

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UniversitaetsSpital Zuerich

Zurich, , Switzerland

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Ibn-i Sina Hospital

Ankara, , Turkey (Türkiye)

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Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, United Kingdom

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Royal United Hospital

Bath, England, United Kingdom

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Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

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Royal Bournemouth Hospital

Bournemouth, England, United Kingdom

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Bristol Haematology and Oncology Centre

Bristol, England, United Kingdom

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Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

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Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, United Kingdom

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Hull Royal Infirmary

Hull, England, United Kingdom

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Kettering General Hosptial

Kettering, Northants, England, United Kingdom

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Clinical Trials and Research Unit of the University of Leeds

Leeds, England, United Kingdom

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Leicester Royal Infirmary

Leicester, England, United Kingdom

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Royal Liverpool and Broadgreen Hospitals NHS Trust

Liverpool, England, United Kingdom

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