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Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275106
Recruitment Status : Terminated (Withdrawn due to an excess of toxic deaths)
First Posted : January 11, 2006
Last Update Posted : July 10, 2013
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment 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 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Primary Purpose: Treatment
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)
Study Start Date : September 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : August 2012

Primary Outcome Measures :
  1. Conditional event-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Acute and long-term toxicity
  3. Non-lymphoma-related deaths and early deaths (excluding deaths occurring after second line treatment for failure or relapse)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed lymphoblastic lymphoma (LBL)

    • Stage I-IV disease
    • T-cell LBL, precursor B-cell LBL, or LBL with an unknown immunophenotype


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00275106

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Giessen, Germany, D-35385
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Royal London Hospital
London, England, United Kingdom, E1 1BB
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
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Study Chair: Robert F. Wynn, MD Royal Manchester Children's Hospital
OverallOfficial: Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F The Christie NHS Foundation Trust
Study Chair: Alfred Reiter, MD University Hospital Erlangen

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00275106     History of Changes
Other Study ID Numbers: CCLG-NHL-2004-08
CDR0000454508 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: April 2008
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
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Dexamethasone acetate
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents