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

T-ALL, T-NHL (Lymphoblastic) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684619
• Other study ID #: LN_GMALLE_2004_55
• Status: Completed
• Phase: Phase 2
• Start date: June 2003
• Est. completion date: December 2008

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T-ALL, T-NHL (Lymphoblastic)

Intervention

Drug:
• Nelarabine
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5

Locations

Country	Name	City	State
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Universitätsklinik Dresden	Dresden	Sachsen
Germany	Universitätsklinikum Essen	Essen	NRW
Germany	University Hospital of Frankfurt, Medical Dept. II	Frankfurt	Hessen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Klinikum der FSU Jena	Jena	Thüringen
Germany	Universitätsklinikum Kiel	Kiel	Schleswig-Holstein
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitätsklinik Münster	Münster	NRW
Germany	Klinikum der Universität Regensburg	Regensburg	Bayern
Germany	Robert Bosch Krankenhaus	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Gökbuget N, Basara N, Baurmann H, Beck J, Brüggemann M, Diedrich H, Güldenzoph B, Hartung G, Horst HA, Hüttmann 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 rela — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL		after 1 cycle and 2 cycles