Clinical trial · Interventional
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
NCT00684619CI-TRIAL-00060403completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-ALL, T-NHL (Lymphoblastic) | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nelarabine | Drug | Nelarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Nelarabine
- interventionNames
- Drug: Nelarabine
Primary outcomes (1)
- measure
- Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
- timeFrame
- after 1 cycle and 2 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTGokbuget 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. PMID 21715318