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

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Collaborator: European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
• Treatments: 6-Mercaptopurine; Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Thioguanine; Vincristine

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