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

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.

Conditions

• Lymphoma

Interventions

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

Sponsors & Collaborators

• European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma

  collaborator OTHER

• Children's Cancer and Leukaemia Group

  lead OTHER

Principal Investigators

• Robert F. Wynn, MD · Royal Manchester Children's Hospital

• Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F · The Christie NHS Foundation Trust

• Alfred Reiter, MD · University Hospital Erlangen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-09-30

Primary Completion

2009-12-31

Completion

2012-08-31

Countries

• Germany
• Ireland
• United Kingdom

Study Locations