Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Sequential Chemotherapy With or Without Rituximab Followed By Ablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation in Patients With Relapsed, CD20 Positive, Aggressive B-Cell Non-Hodgkin's Lymphoma

Basic Trial Information

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• 18-65 years old
• No CNS involvement
• At least 1 month since biological therapy, chemotherapy, or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups.

During a 5-month period, patients in group one will receive infusions of combination chemotherapy. Peripheral stem cells will then be collected, and patients will receive chemotherapy for another 6 days.

Patients in group two will receive the same treatment as group one plus up to three courses of rituximab. Peripheral stem cells will then be reinfused in both groups. Some patients will undergo radiation therapy.

All patients will receive follow- up evaluations every 6 months for 3 years and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Commissie Voor Klinisch Toegepast Onderzoek

Edo Vellenga, MD, Protocol chair		Ph: 31-50-361-2317 Email: e.vellenga@int.umcg.nl

Belgium
	Leuven
	U.Z. Gasthuisberg
		G.E.G. Verhoef, MD, PhD	Ph:  32-16-34608
			Email: gregor.verhoef@uz.kuleuven.ac.be
Netherlands
	Amersfoort
	Meander Medisch Centrum
		M.H.H. Kramer, MD, PhD	Ph:  31-33-422-5511
	Amsterdam
	Academisch Medisch Centrum at University of Amsterdam
		M. H. J. Van Oers, MD	Ph:  31-20-566-5785
			Email: m.H.vanoers@amc.uva.nl
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		J. Baars, MD, PhD	Ph:  31-20-512-2570 or 512-2568
	Vrije Universiteit Medisch Centrum
		P. C. Huijgens, MD, PhD	Ph:  31-20-444-2604
			Email: pc.huijgens@vumc.nl
	Enschede
	Medisch Spectrum Twente
		M.R. Schaafsma, MD	Ph:  31-53-487-2444
	Groningen
	University Medical Center Groningen
		G. W. Van Imhoff, MD, PhD	Ph:  31-50-361-2354
			Email: g.w.van.imhoff@int.umcg.nl
	Leeuwarden
	Medisch Centrum Leeuwarden - Zuid
		P. Joosten, MD	Ph:  31-58-286-6965
	Leiden
	Leiden University Medical Center
		Willem Fibbe, MD, PhD	Ph:  31-71-526-5129
	Maastricht
	Academisch Ziekenhuis Maastricht
		Harry Schouten, MD, PhD	Ph:  31-43-387-7025
			Email: h.schouten@intmed.unimaas.nl
	Nieuwegein
	Sint Antonius Ziekenhuis
		D.H. Biesma, MD	Ph:  31-30-609-2088
			Email: d.biesma@antonius.net
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		John Raemaekers, MD, PhD	Ph:  31-24-361-4762
			Email: J.Raemaekers@hemat.umcn.nl
	Rotterdam
	Daniel Den Hoed Cancer Center at Erasmus Medical Center
		Pieter Sonneveld, MD, PhD	Ph:  31-10-439-1911
			Email: p.sonneveld@erasmusmc.nl
	's-Gravenhage
	HagaZiekenhuis - Locatie Leyenburg
		Pierre Wijermans, MD, PhD	Ph:  31-70-359-2556
			Email: pwijermans@hagaziekenhuis.nl
	's-Hertogenbosch
	Jeroen Bosch Ziekenhuis
		H. Sinnige, MD	Ph:  31 73 6162452
	Utrecht
	University Medical Center Utrecht
		Anton Hagenbeek, MD, PhD	Ph:  31-30-250-7769
			Email: a.hagenbeek@umcutrecht.nl
	Zwolle
	Isala Klinieken - locatie Sophia
		Marinus Van Marwijk Kooij, MD	Ph:  31-38-424-7039

Registry Information
Official Title		A Randomised Phase III Study On The Effect Of The Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) During Sequential Chemotherapy Followed By Autologous Stem Cell Transplantation In Patients With Relapse B-Cell Non-Hodgkin Lymphoma(HOVON 44 STUDY)
Trial Start Date		2000-09-01
Registered in ClinicalTrials.gov		NCT00012051
Date Submitted to PDQ		2001-01-04
Information Last Verified		2007-03-26

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