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

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.

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Key information

Conditions

T-ALL, T-NHL (Lymphoblastic) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Robert Bosch Krankenhaus, Stuttgart, Baden-Wurttemberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

nelarabine

Drug

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

Other names: Compound 506U78, Atriance, Arranon

Primary outcomes

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

Time frame: after 1 cycle and 2 cycles

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)

Important dates

Study start: 2003
Primary completion: 2008
Study completion: 2008
First posted: May 26, 2008
Registry last updated: Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed