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

Goethe University

Status and phase: Completed; Phase 2

Conditions: T-ALL, T-NHL (Lymphoblastic)

Treatments: Drug: Nelarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00684619

LN_GMALLE_2004_55

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Arm A

Experimental group

Description:

Nelarabine

Treatment:

Drug: Nelarabine