Status:
COMPLETED
Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic
Eligibility:
All Genders
Up to 64 years
Phase:
PHASE1
Brief Summary
In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical...
Eligibility Criteria
Inclusion
- 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) \<=3 x upper limit of normal, bilirubin is less than 1.5 times of upper limit of normal(\<=5 x upper limit of normal if it is related by T-ALL or T-LBL).
- Adequate performance status (ECOG-PS\<=2).
- Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
- Patient is willing to accept hospitalization during the blood sampling for pharmacokinetic measurement (i.e., Cohort 1: for pharmacokinetic sample collection during both cycle 1 and 2; and Cohort 2: for pharmacokinetic sample collection during cycle 1).
- Female subjects who are of child-bearing potential must have a negative pregnancy test at the Screening Visit and agree to utilize contraceptive methods during participation in the study and for at least six months following the last dose of 506U78 Injection. Female subjects may be defined as of non-child-bearing potential if they are physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses.
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00406757
Start Date
August 30 2006
End Date
July 15 2009
Last Update
November 13 2017
Active Locations (3)
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1
GSK Investigational Site
Aichi, Japan, 460-0001
2
GSK Investigational Site
Tokyo, Japan, 104-0045
3
GSK Investigational Site
Tokyo, Japan, 104-8560