Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic
Conditions
Interventions
Product Name: NELARABINE
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NELARABINE
CAS Number: 121032-29-9
Current Sponsor code: NELARABINE
Other descriptive name: NELARABIN
Sponsors
GlaxoSmithKline Research & Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologic or cytogenetic documented diagnosis of T-ALL or T-LBL. - Disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen. - At least 4 weeks since the last dose of prior last chemotherapy, or radiotherapy before beginning treatment with 506U78 (2 weeks is permitted if growth of blast cells is significant). - Adequate function of other organ systems as measured as follows.Serum creatinine is less than 1.5 times of upper limit of normal and estimated creatinine clearance >=50 mL/min. Hepatic transaminases (SGPT and SGOT) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Active infection at time of treatment. - Concurrent disease or condition that would make the subject inappropriate for study participation. - Receiving any other anticancer agents or enrolled on any investigational study during the course of the study. - Patients must have recovered to Grade I or less toxicity of all previous chemotherapy prior to treatment. - History of seizure disorder within one year prior to the date of informed consent. - Pregnancy (as demonstrated by a positive pregnancy test at pre-study/screening) or breastfeeding. Fertile women and men must practice adequate contraception throughout the study and at least 6 month after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: T o evaluate the safety and tolerability of nelarabine administered to Japanese patients with T-ALL or TLBL as a 2-hour intravenous infusion on a Day 1, 3 and 5 schedule for adult patients and as a 1-hour infusion on a Days 1-5 schedule for pediatric patients.;Secondary Objective: To determine the plasma pharmacokinetic (PK) profiles of nelarabine and ara-G when nelarabine is administered on these schedules. •To determine intracellular ara-GTP concentrations when nelarabine is administered on these schedules*. * Cohort 3 is established if possible at each of the centres. Determination of intracellular ara-GTP concentrations is not performed in subjects who have received induction therapy. Primary Outcome/;Primary end point(s): • Safety and tolerability: Adverse events (AEs), physical examinations, laboratory tests, 12-lead ECG • Plasma PK parameters (e.g., AUC, Cmax) for nelarabine and ara-G • Intracellular ara-GTP concentrations (e.g., Cmax, trough level);Timepoint(s) of evaluation of this end point: 2-hour intravenous infusion on a Day 1, 3 and 5 schedule for adult patients and as a 1-hour Infusion on a Days 1-5 schedule for pediatric patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects with complete response with and without hematologic recovery (CR and CR*, respectively) in the assessment of best overall response;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed