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

Goethe University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

T-ALL, T-NHL (Lymphoblastic)

Interventions

NelarabineDRUG

1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (11)

Robert Bosch Krankenhaus

Stuttgart, Baden-Wurttemberg, Germany

Klinikum der Universität Regensburg

Regensburg, Bavaria, Germany

University Hospital of Frankfurt, Medical Dept. II

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL

Time frame: after 1 cycle and 2 cycles

Data from ClinicalTrials.gov

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