Leukaemia, Lymphoblastic, AcuteNCT00866671
Observational Study of Nelarabine in Children and Young Adults
An observational study of Leukaemia, Lymphoblastic, Acute, run by GlaxoSmithKline at 31 sites in 9 countries.
Trial summary
This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Leukaemia, Lymphoblastic, Acute
- What is being tested?
- nelarabine
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 31 sitesin 9 countries
- Study dates
- Feb 2009to Sep 2014
- Phase
- Observational
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
Who may be able to join
- ≤ 21 years of age
- Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
- Prior treatment with at least two chemotherapy regimens
- Selected for treatment with nelarabine
Who cannot join
- Known hypersensitivity to the active substance.
- Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
- Males with partners of child bearing potential who are not willing to use condoms or abstinence
- Patients with persistent neurological toxicity (CTC grade > = grade 2)
- Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
France7 sites
GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Paris, 75935
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511
Poland5 sites
GSK Investigational Site
Bydgoszcz
GSK Investigational Site
Lublin, 20-093
GSK Investigational Site
Warsaw, 00-576
GSK Investigational Site
Warsaw, 02-781
GSK Investigational Site
Wroclaw, 50-345
Denmark4 sites
GSK Investigational Site
Aahur N
GSK Investigational Site
Aalborg, DK-9100
GSK Investigational Site
Koebenhavn Oe, 2100
GSK Investigational Site
Odense C
Israel4 sites
GSK Investigational Site
Beersheba, 84101
GSK Investigational Site
Haifa, 31096
GSK Investigational Site
Petah Tikva
GSK Investigational Site
Ramat Gan, 52621
Spain4 sites
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Boadilla Del Monte (Madrid), 28660
GSK Investigational Site
Madrid, 28009
GSK Investigational Site
Madrid, 28047
Russia3 sites
GSK Investigational Site
Krasnodar, 350007
GSK Investigational Site
Moscow, 117997
GSK Investigational Site
Moscow, 119049
Germany2 sites
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma
This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).
- Conditions
- Leukaemia, Lymphoblastic, Acute
- Being tested
- nelarabine
- Keywords
- T-ALL, Safety, Post Authorisation Safety Study, T-LBL, Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic 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.
nelarabineDrug
Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.
| Study group | Role | What they receive |
|---|---|---|
| Nelarabine | nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days. Receives: Drug: nelarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological adverse events
Measured: Up to one year after treatment
Secondary outcomes (2)
Other adverse events
Measured: Up to one year after treatment
clinical response rate and survival
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukaemia, Lymphoblastic, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 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
- NCT00866671
- Sponsor's protocol ID
- 111081
- Status last verified
- Jan 2015
- First submitted
- 19 Mar 2009
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma
- ClinicalTrials.gov ID
- NCT00866671
- Acronym / sponsor ID
- 111081
- Conditions
- Leukaemia, Lymphoblastic, Acute
- Keywords
- T-ALL, Safety, Post Authorisation Safety Study, T-LBL, Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Mar 2009 (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.
This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelarabine | – | Drug: nelarabinenelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
Key inclusion criteria (4 listed)
- ≤ 21 years of age
- Relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
- Prior treatment with at least two chemotherapy regimens
- Selected for treatment with nelarabine
Key exclusion criteria (5 listed)
- Known hypersensitivity to the active substance.
- Women of childbearing potential who are unable or unwilling to use adequate contraceptive measures
- Males with partners of child bearing potential who are not willing to use condoms or abstinence
- Patients with persistent neurological toxicity (CTC grade > = grade 2)
- Adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.
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 |
|---|---|---|
| nelarabineNelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue. | Drug | Nelarabine |
Primary outcome
Neurological adverse events
Time frame: Up to one year after treatment
2 secondary outcomes
Other adverse events
Time frame: Up to one year after treatment
clinical response rate and survival
Time frame: one year
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 14 Jan 2015.
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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
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukaemia, Lymphoblastic, Acute, run by GlaxoSmithKline at 31 sites in 9 countries.
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 4 inclusion and 5 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 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Poland, Denmark, Israel, Spain and 4 more countries. 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.
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?
Neurological adverse events (time frame: Up to one year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2015.