Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Intervention: Nelarabine (506U78) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718
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 trial, patients whose disease has not responded to or has relapsed
after treatment with multiple prior chemotherapy regimens have no accepted standard therapies
available. Japanese leukemia experts have expressed interest in evaluating 506U78 in
Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety,
tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed
to maximize the contribution of each available patient.
Clinical Details
Official title: Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma.
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Primary outcome: Adverse events
Changes from baseline in physical examination and clinical laboratory parameters
12-lead ECG
Assessment of pharmacokinetic endpoints of 506U78, ara-G and intracellular ara-GTP concentration.
Secondary outcome: Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement.
Eligibility
Minimum age: N/A.
Maximum age: 64 Years.
Gender(s): Both.
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) <=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 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.
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718
GSK Investigational Site, Tokyo 104-0045, Japan; Recruiting
GSK Investigational Site, Aichi 460-0001, Japan; Recruiting
Additional Information
Starting date: August 2006
Ending date: June 2008
Last updated: October 15, 2008
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