No registrations found.
ID
NL-OMON21662
Source
NTR
Brief title
Interfant 99
Health condition
Acute lymphoblastic leukemia.
Sponsors and support
Primary sponsor
:
Interfant Collaborative Group.
Source(s) of monetary or material Support
:
N/A
Intervention
Outcome measures
Primary outcome
Event Free Survival.
Secondary outcome
N/A
Background summary
Outcome for infant ALL is relatively poor. The Interfant-99 protocol has 3 aims:
1. assess`the outcome of a hybrid therapy schedule including AML elements on an ALL backbone.
2. assess the value of a late intensification course (VIMARAM) including high-dose araC.
3. determine which clinical and biological factors have independent prognostic relevance.
Study objective
A late intensification course (VIMARAM) improves the outcome of infants with acute lymphoblastic leukemia.
Study design
N/A
Intervention
Intensification course VIMARAM.
Public
Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology,
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Scientific
Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology,
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Inclusion criteria
1. Age < 366 days;
2. Acute lymphoblastic leukemia.
Exclusion criteria
Prior therapy for leukemia (except emergency treatment).
Design
Study type
:
Interventional
Intervention model
:
Parallel
Allocation
:
Randomized controlled trial
Masking
:
Open (masking not used)
Control
:
Active
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
500
Type
:
Actual
Positive opinion
Date
:
Application type
:
First submission
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL147 |
| NTR-old | NTR182 |
| Other | : N/A |
| ISRCTN | ISRCTN24251487 |
Summary results
Lancet. 2007 Jul 21;370(9583):240-50.