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Combination Chemotherapy in Treating Children With Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00003650
Recruitment Status : Unknown
Verified March 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 21, 2011
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy Phase 3

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Detailed Description:


  • Assess the event free survival at 2 and 5 years of children with T cell or pre-B cell non-Hodgkin's lymphoma treated with a sequential induction regimen, a consolidation regimen, a reintensification regimen, and a maintenance regimen.
  • Assess the rate of local relapse at 2 and 5 years of these children after receiving this treatment.
  • Determine the toxicity of this treatment in these patients.
  • Determine the overall survival of these children at 5 years after receiving this treatment.

OUTLINE: This is a multicenter study.

Patients receive 5 weeks of induction chemotherapy consisting of prednisone IV twice a day on days 1-28, then decreasing in dose on days 29-35; vincristine IV on days 8, 15, 22, and 29; cyclophosphamide IV over 1 hour on day 8; daunorubicin IV over 24 hours on days 15, 22, and 29; asparaginase IV or IM on days 16, 18, 20, 23, 25, 27, 30, and 32; and methotrexate IV over 3 hours on day 8. Patients also receive methotrexate and methylprednisolone intrathecally (IT) on days 1, 4, 9, and 15.

Patients with a response over 50% proceed to 4-8 weeks of consolidation therapy. This regimen consists of vincristine IV on day 15, cyclophosphamide IV over 1 hour followed by methotrexate over 3 hours on day 1, cytarabine IV on days 2-5 and 8-11, asparaginase IV or IM on days 16 and 23, and methotrexate IV over 3 hours on day 15. Patients also receive methotrexate and methylprednisolone IT on days 2 and 16. Patients who achieve complete remission after 4 weeks repeat consolidation therapy for another course.

Patients then receive 4 weeks of interphase therapy consisting of oral mercaptopurine on days 1 and 22, methotrexate IV over 3 hours on days 1 and 15, and methotrexate and methylprednisolone IT on days 2 and 16.

Patients with pre-B cell lymphoma then proceed to maintenance therapy. Patients with T cell lymphoma proceed to reinduction therapy. Reinduction A is a 4 week course of chemotherapy administered during months 1, 3, and 5 and consists of vincristine IV on day 1; methotrexate IV over 3 hours on days 1, 8, 15, and 22; methotrexate and methylprednisolone IT on day 2; asparaginase IM or IV on day 2; and oral mercaptopurine. Reinduction B is also a 4 week course of therapy administered during months 2, 4, and 6. This consists of oral prednisone twice a day on days 1-5; cytarabine subcutaneously twice a day on days 1-4; methotrexate IV on days 1, 8, 15, and 22; and oral mercaptopurine.

Patients then proceed to maintenance therapy, which consists of methotrexate and mercaptopurine once a week. Patients with stage I, II, or III disease continue maintenance therapy for 18 months, while patients with stage IV disease continue this therapy for 24 months.

Patients with stage IV disease with neuromeningeal involvement receive triple intrathecal therapy consisting of methotrexate, cytarabine, and methylprednisolone, then reinduction A for months 1, 2, and 3, then reinduction B for months 4, 5, and 6 (if T cell lymphoma). These patients also receive cerebral irradiation during months 4 and 5. Patients with pre-B cell disease receive cerebral irradiation after intensification therapy.

Patients with less than 50% response after induction therapy or incomplete remission after 4-8 weeks of consolidation therapy, or who have a recurrence of disease are treated with the "VANDA" regimen consisting of dexamethasone on days 1-5; cytarabine over 3 hours twice a day on days 1 and 2; mitoxantrone IV over 1 hour on days 3 and 4; etoposide IV over 1 hour on days 3-5; and asparaginase IV over 1 hour or IM on days 7, 9, 11, and 13. Patients also receive triple intrathecal therapy (methotrexate, cytarabine, and methylprednisolone) on day 5.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 4 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Primary Purpose: Treatment
Official Title: Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma
Study Start Date : June 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically and/or cytologically confirmed T cell or pre-B cell non-Hodgkin's lymphoma

    • Lymphoblastic or peripheral T cell
    • Stage I, II, III, or IV
  • No anaplastic lymphoma, large cell lymphoma, or small noncleaved cell lymphoma



  • 18 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No prior malignancy
  • No chronic medical or psychological condition
  • No congenital immunodeficiency
  • HIV and HTLV negative
  • Not pregnant


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed


  • Not specified


  • No prior organ transplant
Contacts and Locations

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): NCT00003650

Centre Leon Berard
Lyon, France, 69373
Sponsors and Collaborators
Study Chair: Christophe Bergeron Centre Leon Berard
More Information

ClinicalTrials.gov Identifier: NCT00003650     History of Changes
Other Study ID Numbers: CDR0000066742
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: March 2001

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:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents