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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.
 
ClinicalTrials.gov Identifier: NCT00275106
Recruitment Status : Terminated (Withdrawn due to an excess of toxic deaths)
First Posted : January 11, 2006
Last Update Posted : July 10, 2013
Sponsor:
Collaborator:
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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00275106


Locations
Show Show 22 study locations
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00275106    
Other Study ID Numbers: CCLG-NHL-2004-08
CDR0000454508 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20598
CCLG-EURO-LIB-02
EICNHL-ERURO-LB02
EUDRACT-2004-0011861-17
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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Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leucovorin
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vincristine
Daunorubicin
Asparaginase
Mercaptopurine
Thioguanine
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents