Leukaemia, Lymphoblastic, Acute and Lymphoma, LymphoblasticPhase 1NCT00406757
Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
A Phase 1 study testing Nelarabine injection 400mg/m2, Nelarabine injection 650mg/m2 and Nelarabine injection 1000mg/m2 in people with Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic, run by GlaxoSmithKline at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic
- What is being tested?
- Nelarabine injection 400mg/m2, Nelarabine injection 650mg/m2 and Nelarabine injection 1000mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesJapan
- Study dates
- 30 Aug 2006to 15 Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Japan3 sites
GSK Investigational Site
Aichi, 460-0001
GSK Investigational Site
Tokyo, 104-0045
GSK Investigational Site
Tokyo, 104-8560
About this study
Official title: Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma.
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.
- Being tested
- Nelarabine injection 400mg/m2, Nelarabine injection 650mg/m2, Nelarabine injection 1000mg/m2, Nelarabine injection 1500mg/m2
- Keywords
- T-cell, T-ALL, T-LBL, 506U78, ara-G, ara-GTP, Lymphoma, Leukemia
- Medical subject headings
- Leukemia, Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelarabine injection 400mg/m2Drug
Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5.
Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5.
Nelarabine injection 650mg/m2Drug
Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5.
Nelarabine injection 1000mg/m2Drug
Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5.
Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
Nelarabine injection 1500mg/m2Drug
Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Arm 1 | Active comparator | Cycle 1: Nelarabine 400mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose.
Cycle 2 and subsequent Cycles: Nelarabine 650mg2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. Receives: Drug: Nelarabine injection 400mg/m2 |
| Pediatric Arm 2 | Active comparator | Cycle 1 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. Receives: Drug: Nelarabine injection 650mg/m2 |
| Adult Arm 1 | Active comparator | Cycle 1: Nelarabine 1000mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose.
Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. Receives: Drug: Nelarabine injection 1000mg/m2 |
| Adult Arm 2 | Active comparator | Cycle 1 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. Receives: Drug: Nelarabine injection 1500mg/m2 |
| Pediatric Arm 3 | Active comparator | Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5. Receives: Drug: Nelarabine injection 650mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 21
Secondary outcomes (1)
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study start30 Aug 2006
- Primary completion15 Jul 2009
- Study completion15 Jul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukaemia, Lymphoblastic, Acute and Lymphoma, LymphoblasticStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406757
- Sponsor's protocol ID
- PGA105446
- Status last verified
- Nov 2017
- First submitted
- 30 Nov 2006
- Last updated
- 13 Nov 2017
- Results posted
- No
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.
PubMed 21737993
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma.
- ClinicalTrials.gov ID
- NCT00406757
- Acronym / sponsor ID
- PGA105446
- Keywords
- T-cell, T-ALL, T-LBL, 506U78, ara-G, ara-GTP, Lymphoma, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2006 (actual)
- Primary completion
- 15 Jul 2009 (actual)
- Study completion
- 15 Jul 2009 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pediatric Arm 1 | Active comparator | Drug: Nelarabine injection 400mg/m2Cycle 1: Nelarabine 400mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. Cycle 2 and subsequent Cycles: Nelarabine 650mg2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. |
| Pediatric Arm 2 | Active comparator | Drug: Nelarabine injection 650mg/m2Cycle 1 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to Day 5 followed by 16 days of off-dose. |
| Adult Arm 1 | Active comparator | Drug: Nelarabine injection 1000mg/m2Cycle 1: Nelarabine 1000mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. |
| Adult Arm 2 | Active comparator | Drug: Nelarabine injection 1500mg/m2Cycle 1 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once daily on Days 1, 3 and 5 followed by 16 days of off-dose. |
| Pediatric Arm 3 | Active comparator | Drug: Nelarabine injection 650mg/m2Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5. |
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nelarabine injection 400mg/m2Cycle 1: Nelarabine 400mg/m2 will be administered once a day from Day 1 to Day 5. Cycle 2 and subsequent Cycles: Nelarabine 650mg/m2 will be administered once daily from Day 1 to DAy 5. | Drug | Pediatric Arm 1 |
| Nelarabine injection 650mg/m2Nelarabine 650mg/m2 will be administered once a day from Day 1 to Day 5. | Drug | Pediatric Arm 2, Pediatric Arm 3 |
| Nelarabine injection 1000mg/m2Cycle 1: Nelarabine 1000mg/m2 will be administered once a day on Days 1, 3 and 5. Cycle 2 and subsequent Cycles: Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5. | Drug | Adult Arm 1 |
| Nelarabine injection 1500mg/m2Nelarabine 1500mg/m2 will be administered once a day on Days 1, 3 and 5. | Drug | Adult Arm 2 |
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.
Time frame: Day 21
1 secondary outcome
Evaluation of response (e.g., CR, CR*) in patients with bone marrow involvement.
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Background: PubMed 21737993Horibe 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.
- Results for study 105446 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nelarabine injection 400mg/m2, Nelarabine injection 650mg/m2 and Nelarabine injection 1000mg/m2 in people with Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic, run by GlaxoSmithKline at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.