506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Goethe University; Johann Wolfgang Goethe University Hospital

Criteria

Inclusion Criteria:

• T-ALL; T-NHL

• age >= 18 years

• cytological treatment failure / relapse

• molecular treatment failure / relapse

• no promising therapy alternatives with approved medication available

• no CNS-manifestation, requiring intrathecal therapy or CNS-radiation

• no convulsive disease or neurotoxicity > grade III in patients history

• written informed consent

• no cytostatic therapy in the last 10 days

• no pregnancy or breastfeeding

• effective contraception

• recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation

Exclusion Criteria:

• Severe psychiatric illness

• uncontrolled or severe cardiac disease or infection

• active secondary neoplasms - except skin cancer (no melanoma)