Observational Study of Nelarabine in Children and Young Adults

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00866671

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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).

Condition or Disease	Intervention/Treatment	Phase
Leukaemia, Lymphoblastic, Acute	Drug: nelarabine

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Nelarabine nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.	Drug: nelarabine Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

Arm

Intervention/Treatment

Nelarabine

nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days.

Drug: nelarabine

Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue.

Outcome Measures

Primary Outcome Measures

Neurological adverse events [Up to one year after treatment]

Secondary Outcome Measures

Other adverse events [Up to one year after treatment]
clinical response rate and survival [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≤ 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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Aahur N		Denmark
2	GSK Investigational Site	Aalborg		Denmark	DK-9100
3	GSK Investigational Site	Koebenhavn Oe		Denmark	2100
4	GSK Investigational Site	Odense C		Denmark
5	GSK Investigational Site	Bordeaux cedex		France	33076
6	GSK Investigational Site	Lille Cedex		France	59037
7	GSK Investigational Site	Nantes Cedex 1		France	44093
8	GSK Investigational Site	Paris Cedex 10		France	75475
9	GSK Investigational Site	Paris cedex 12		France	75571
10	GSK Investigational Site	Paris Cedex 19		France	75935
11	GSK Investigational Site	Vandoeuvre-Les-Nancy		France	54511
12	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45122
13	GSK Investigational Site	Hamburg		Germany	20246
14	GSK Investigational Site	Beer-Sheva		Israel	84101
15	GSK Investigational Site	Haifa		Israel	31096
16	GSK Investigational Site	Petach-Tikva		Israel
17	GSK Investigational Site	Ramat Gan		Israel	52621
18	GSK Investigational Site	Bologna	Emilia-Romagna	Italy	40137
19	GSK Investigational Site	Rotterdam		Netherlands	3015 GJ
20	GSK Investigational Site	Bydgoszcz		Poland
21	GSK Investigational Site	Lublin		Poland	20-093
22	GSK Investigational Site	Warszawa		Poland	00-576
23	GSK Investigational Site	Warszawa		Poland	02-781
24	GSK Investigational Site	Wroclaw		Poland	50-345
25	GSK Investigational Site	Krasnodar		Russian Federation	350007
26	GSK Investigational Site	Moscow		Russian Federation	117997
27	GSK Investigational Site	Moscow		Russian Federation	119049
28	GSK Investigational Site	Barcelona		Spain	08035
29	GSK Investigational Site	Boadilla del Monte (Madrid)		Spain	28660
30	GSK Investigational Site	Madrid		Spain	28009
31	GSK Investigational Site	Madrid		Spain	28047