Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy, such as prednisolone and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known whether prednisolone is more effective than dexamethasone when given together with combination chemotherapy in treating lymphoblastic lymphoma.

PURPOSE: This phase III randomized clinical trial is studying prednisolone to see how well it works compared to dexamethasone when given together with combination chemotherapy in treating young patients with newly diagnosed lymphoblastic lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisolone Drug: thioguanine Drug: vincristine sulfate Procedure: radiation therapy	Phase III

MedlinePlus related topics:

Cancer Lymphoma

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Vincristine sulfate Vincristine Calcium gluconate Thioguanine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Official Title:	Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-Group Co-Operation on Childhood Non-Hodgkin-Lymphoma (EICNHL)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Conditional event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Acute and long-term toxicity [ Designated as safety issue: Yes ]
Non-lymphoma-related deaths and early deaths (excluding deaths occurring after second line treatment for failure or relapse) [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	September 2004
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed lymphoblastic lymphoma (LBL)
- Stage I-IV disease
- T-cell LBL, precursor B-cell LBL, or LBL with an unknown immunophenotype

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No known HIV or AIDS infection
No severe immunodeficiency
No other prior malignancy
No prior disease that would preclude treatment with chemotherapy

PRIOR CONCURRENT THERAPY:

More than 2 months since prior systemic corticosteroids for a duration of > 8 days
No prior chemotherapy
No prior radiotherapy
No prior organ transplant
No trimethoprim-sulfamethoxazole 6 days before or during methotrexate therapy
No concurrent participation in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275106

Locations


Germany
	Kinderklinik	Recruiting
	Giessen, Germany, D-35385
	Contact: Alfred Reiter, MD 49-641-994-3420

Ireland
	Our Lady's Hospital for Sick Children Crumlin	Recruiting
	Dublin, Ireland, 12
	Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie

United Kingdom, England
	Addenbrooke's Hospital	Recruiting
	Cambridge, England, United Kingdom, CB2 2QQ
	Contact: Amos Burke, MD 44-1223-348-151
	Birmingham Children's Hospital	Recruiting
	Birmingham, England, United Kingdom, B4 6NH
	Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk
	Children's Hospital - Sheffield	Recruiting
	Sheffield, England, United Kingdom, S10 2TH
	Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk
	Queen's Medical Centre	Recruiting
	Nottingham, England, United Kingdom, NG7 2UH
	Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 martin.hewitt@nuh.nhs.uk
	Institute of Child Health at University of Bristol	Recruiting
	Bristol, England, United Kingdom, BS2 8AE
	Contact: Pamela Kearns, MD 44-117-342-0205
	Leeds Cancer Centre at St. James's University Hospital	Recruiting
	Leeds, England, United Kingdom, LS9 7TF
	Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk
	Leicester Royal Infirmary	Recruiting
	Leicester, England, United Kingdom, LE1 5WW
	Contact: Mabrouk Madi, MD 44-116-258-5959
	Oxford Radcliffe Hospital	Recruiting
	Oxford, England, United Kingdom, 0X3 9DU
	Contact: Kate Wheeler, MD 44-186-522-1066
	Great Ormond Street Hospital for Children	Recruiting
	London, England, United Kingdom, WC1N 3JH
	Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073
	Royal Liverpool Children's Hospital, Alder Hey	Recruiting
	Liverpool, England, United Kingdom, L12 2AP
	Contact: Heather P. McDowell, MD 44-151-293-3679
	Royal London Hospital	Recruiting
	London, England, United Kingdom, E1 1BB
	Contact: Ananth Shankar, MD 44-20-7380-9950 a.shankar@cancer.org.uk
	Royal Manchester Children's Hospital	Recruiting
	Manchester, England, United Kingdom, M27 4HA
	Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk
	Royal Marsden - Surrey	Recruiting
	Sutton, England, United Kingdom, SM2 5PT
	Contact: Mary Taj, MD 44-20-8642-6011 ext. 3089
	Sir James Spence Institute of Child Health	Recruiting
	Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
	Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk
	Southampton General Hospital	Recruiting
	Southampton, England, United Kingdom, SO16 6YD
	Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942

United Kingdom, Northern Ireland
	Royal Belfast Hospital for Sick Children	Recruiting
	Belfast, Northern Ireland, United Kingdom, BT12 6BE
	Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk

United Kingdom, Scotland
	Royal Aberdeen Children's Hospital	Recruiting
	Aberdeen, Scotland, United Kingdom, AB25 2ZG
	Contact: Derek King, MD 44-1224-681-818
	Royal Hospital for Sick Children	Recruiting
	Glasgow, Scotland, United Kingdom, G3 8SJ
	Contact: Milind D. Ronghe, MD 44-141-201-9309
	Royal Hospital for Sick Children	Recruiting
	Edinburgh, Scotland, United Kingdom, EH9 1LF
	Contact: W. Hamish Wallace, MD 44-131-536-0426

United Kingdom, Wales
	Childrens Hospital for Wales	Recruiting
	Cardiff, Wales, United Kingdom, CF14 4XW
	Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma

Investigators


Study Chair:	Robert F. Wynn, MD	Royal Manchester Children's Hospital

Investigator:	Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F	Christie Hospital

Study Chair:	Alfred Reiter, MD	Kinderklinik

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000454508, CCLG-NHL-2004-08, EU-20598, CCLG-EURO-LIB-02, EICNHL-ERURO-LB02, EUDRACT-2004-0011861-17
First Received:	January 10, 2006
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00275106
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I childhood lymphoblastic lymphoma

stage II childhood lymphoblastic lymphoma

stage III childhood lymphoblastic lymphoma

stage IV childhood lymphoblastic lymphoma

Study placed in the following topic categories:

Dexamethasone

Daunorubicin

Leukemia, Lymphoid

Methylprednisolone

Lymphoma, small cleaved-cell, diffuse

Leucovorin

Prednisolone acetate

Cyclophosphamide

6-Mercaptopurine

Leukemia

Methotrexate

Lymphoma

Dexamethasone acetate

Cytarabine

Methylprednisolone Hemisuccinate

Asparaginase

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Thioguanine

Methylprednisolone acetate

Vincristine

Lymphoblastic lymphoma

Doxorubicin

Folic Acid

Lymphatic Diseases

Prednisolone

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Antiemetics

Reproductive Control Agents

Antibiotics, Antineoplastic

Neuroprotective Agents

Hormones

Vitamins

Therapeutic Uses

Abortifacient Agents

Micronutrients

Dermatologic Agents

Alkylating Agents

Nucleic Acid Synthesis Inhibitors

Vitamin B Complex

Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal

Immune System Diseases

Growth Substances

Mitosis Modulators

Gastrointestinal Agents

Enzyme Inhibitors

Antimitotic Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Children's Cancer and Leukaemia Group European Inter-Group Co-operation on Childhood Non-Hodgkin Lymphoma
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00275106