T-ALL, T-NHL (Lymphoblastic)
Conditions
Brief 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.
Interventions
DRUGNelarabine
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Sponsors
Goethe University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL | after 1 cycle and 2 cycles |
Countries
Germany
Outcome results
None listed