Clinical trial NCT00684619: 506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Official title: Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: T-ALL, T-NHL (Lymphoblastic)
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
timeFrame: after 1 cycle and 2 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
state: Baden-Württemberg
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
state: Bayern
city: Frankfurt
country: Germany
facility: University Hospital of Frankfurt, Medical Dept. II
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: NRW
city: Münster
country: Germany
facility: Universitätsklinik Münster
state: NRW
city: Dresden
country: Germany
facility: Universitätsklinik Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Klinikum der FSU Jena
state: Thüringen
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
Study officials:
affiliation: University Hospital of Frankfurt, Medical Dept. II
name: Dieter Hoelzer, MD, PhD
role: STUDY_CHAIR
References:
citation: Gokbuget N, Basara N, Baurmann H, Beck J, Bruggemann M, Diedrich H, Guldenzoph B, Hartung G, Horst HA, Huttmann A, Kobbe G, Naumann R, Ratei R, Reichle A, Serve H, Stelljes M, Viardot A, Wattad M, Hoelzer D. High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation. Blood. 2011 Sep 29;118(13):3504-11. doi: 10.1182/blood-2011-01-329441. Epub 2011 Jun 28.