No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
Event free survival.
Secondary outcome
Survival.
Background summary
Infant acute lymphoblastic leukemia (ALL) has a poor prognosis compared to ALL in older children. Becuase it is a rare disease, in 1999 an international collaboration was started to try to improve outcome for infant ALL. Interfant-99 was the first study leading to an event-free survival of 47%. Early bone marrow relapses were the major reason for therapy failure. The interfant-06 study aims to improve therapy by comparing two different early therapy intensifications: two "AML" induction blocks versus protocol Ib given directly after induction therapy in patients with a MLL gene rearrangement. Other aims are:
- to assess the outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99.
- To study which factors have independent prognostic value.
- To assess the role of SCT in patients at high risk for relapse.
Study objective
The primary aim of the study is:
1. To assess the role of an early intensification of two "AML" induction blocks versus protocol Ib directly after induction, in a randomized way in MR and HR patients.
Secondary aims are:
2. To assess the role of an early intensification of two "AML" induction blocks versus protocol Ib directly after induction, in a randomized way in MR and HR patients, separately.
3. To assess the overall outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99.
4. To assess the outcome of LR, MR and HR patients as compared to the historical control series in Interfant-99.
5. To study which factors have independent prognostic value.
6. To assess the role of SCT in HR patients.
Intervention
Comparison of early intensification of two "AML" induction blocks versus protocol Ib directly after induction, in a randomized way in medium risk and high risk patients.
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. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to EGIL criteria. Children with CNS or testicular leukemia at diagnosis are eligible;
2. Morphological verification of the diagnosis, confirmed with cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a “dry tap”, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination;
3. Informed consent of the parents or other legally authorized guardian of the patient.
Exclusion criteria
1. Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL;
2. The presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if these data are not known, the patient is eligible);
3. Age > 365 days;
4. Relapsed ALL;
5. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
Design
Recruitment
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 | NL635 |
| NTR-old | NTR695 |
| Other | : N/A |
| ISRCTN | ISRCTN12500962 |