Last updated: 11/04/2018 10:13:44
Clinical Evaluation of Nelarabine (506U78)in Japanese Patients with Leukemia or Lymphoma
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of 506U78 in Japanese Patients with Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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.
Timeframe: Day 21
Secondary outcomes:
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement.
Timeframe: Day 21
Interventions:
Drug: Nelarabine injection 400mg/m2
Drug: Nelarabine injection 650mg/m2
Drug: Nelarabine injection 1000mg/m2
Drug: Nelarabine injection 1500mg/m2
Enrollment:
13
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Nobuyuki Koh. Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL . [Rinsho Ketsueki]. 2011;52(6):406-415.
Medical condition
Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic
Product
nelarabine
Collaborators
Not applicable
Study date(s)
August 2006 to July 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
Not applicable - 64 years
Accepts healthy volunteers
No
- 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.
- Active infection at time of treatment.
- Concurrent disease or condition that would make the subject inappropriate for study participation.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-15-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 105446 can be found on the GSK Clinical Study Register.
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