Status:
TERMINATED
Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Collaborating Sponsors:
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
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....
Detailed Description
OBJECTIVES: Primary * Compare the event-free survival of young patients with newly diagnosed lymphoblastic lymphoma treated with induction prednisolone vs dexamethasone. * Compare the safety of stan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00275106
Start Date
September 1 2004
End Date
August 1 2012
Last Update
July 10 2013
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Kinderklinik
Giessen, Germany, D-35385
2
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
3
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
4
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE