506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
This study has been completed.
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00684619
First received: May 16, 2008
Last updated: August 20, 2010
Last verified: May 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
T-ALL, T-NHL (Lymphoblastic) |
Drug: Nelarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7) |
Resource links provided by NLM:
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
Primary Outcome Measures:
- Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL [ Time Frame: after 1 cycle and 2 cycles ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Nelarabine
- Compound 506U78
- Atriance
- Arranon
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684619
Locations
| Germany | |
| Robert Bosch Krankenhaus | |
| Stuttgart, Baden-Württemberg, Germany, 70376 | |
| Klinikum der Universität Regensburg | |
| Regensburg, Bayern, Germany, 93042 | |
| University Hospital of Frankfurt, Medical Dept. II | |
| Frankfurt, Hessen, Germany, 60590 | |
| Medizinische Hochschule Hannover | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Universitätsklinikum Essen | |
| Essen, NRW, Germany, 45147 | |
| Universitätsklinik Münster | |
| Münster, NRW, Germany, 48149 | |
| Universitätsklinik Dresden | |
| Dresden, Sachsen, Germany, 01307 | |
| Universitätsklinikum Leipzig | |
| Leipzig, Sachsen, Germany, 04103 | |
| Universitätsklinikum Kiel | |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Klinikum der FSU Jena | |
| Jena, Thüringen, Germany, 07747 | |
| HELIOS Klinikum Berlin-Buch | |
| Berlin, Germany, 13125 | |
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
| Study Chair: | Dieter Hoelzer, MD, PhD | University Hospital of Frankfurt, Medical Dept. II |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dieter Hoelzer, MD, PhD, University Hospital of Frankfurt |
| ClinicalTrials.gov Identifier: | NCT00684619 History of Changes |
| Other Study ID Numbers: | LN_GMALLE_2004_55 |
| Study First Received: | May 16, 2008 |
| Last Updated: | August 20, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia-Lymphoma, Adult T-Cell Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, T-Cell |
ClinicalTrials.gov processed this record on June 18, 2013