Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic; Lymphoblastic Lymphoma; Acute Lymphoblastic Leukemia
Intervention: Nelarabine injection 400mg/m2 (Drug); Nelarabine injection 650mg/m2 (Drug); Nelarabine injection 1000mg/m2 (Drug); Nelarabine injection 1500mg/m2 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adverse events, changes from baseline in physical examination and clinical laboratory parameters12-lead ECGAssessment 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
GSK Investigational Site, Aichi 460-0001, Japan
GSK Investigational Site, Tokyo 104-0045, Japan
GSK Investigational Site, Tokyo 104-8560, Japan
Additional Information
Related publications: Horibe K, Takimoto T, Yokozawa T, Makimoto A, Kobayashi Y, Ogawa C, Ohno R, Koh N, Katsura K, Tobinai K. [Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL]. Rinsho Ketsueki. 2011 Jun;52(6):406-15.
Starting date: August 2006
Last updated: May 31, 2012
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