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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

Page last updated: August 23, 2015

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