| DEC-NET Serial number FR319 |
| |
| Published online | 20/09/2004 15.50.00 |
| Last updated | 27/11/2006 10.32.39 |
| |
| Other protocol ID number | 000608 |
| Current trial status | Closed to recruitment of participants: follow-up continuing |
Major Disease
(ICD9 class) | MYELOID LEUKEMIA CHRONIC |
| Experimental drug |
cytosine arabinoside
Treatment regimen (dosage and duration)
20 mg/m2/day durig 10 days subcutaneous administration |
Interferon alpha 2 b
Treatment regimen (dosage and duration)
5 Millions UI/m2/day at day 1 to day 28 in subcutaneous |
| Gender | Both |
| Age (range) | under 18 years |
Eligibility criteria |
| Inclusion criteria |
| All the following criteria should be present to include a patient :
-Written parental informed consent
-Chronic myeloid leukemia confirmed by the presence of the translocation on medullary cytogenetic analysis
-Recent Diagnosis (less than 2 months);
-Patient having stopped hydroxyurea;
-Absence of previous chemotherapy except with hydroxyurea;
- Absence of organic cardiac, pulmonary, hepatic, renal or neurological disease (grade > 2), according to WHO classification;
- No contraindication to interferon (epilepsy, depressive syndrome, renal and hepatic failure);
-Contraceptive method throughout the study in the pubescent girls;
-Patient who may regularly be followed at least during 2 years. |
| Exclusion criteria |
| - Absence of parental written informed consent
-Age equal to or higher than 18 years;
-Signs of acceleration or acute transformation according to defined criteria; or absence of translocation;
-Diagnosis dating from 2 months or more;
-Patient uner hydroxyurea
-Patient previously treated
-Contraindication to interferon (epilepsy, depressive syndrome, renal renal and hepatic failure) or presence of organic disease (grade > 2), according to WHO classification
- Pregnancy or absence of contraception in girls of childbearing age;
-Patient without possibility of clinical, biological or cytogenetic follow-up during at least 2 years. |
Trial design/methodology |
| Phase | 2 |
| Kind of study | Efficacy
Safety
|
| Design | |
| Purpose of study |
| To determine:
- The hematologic rate of remission after 12 weeks of treatment and the delay for remission;
- The major or complete cytogenetic rate of remission after 52 weeks of treatment and the delay for answer
- The clinical and biological tolerance of the association IFN-cytosine-arabinoside. |
| Primary outcomes |
| *Efficacy of the association of interferon /cytosine-arabinoside on :
- the hematologic rate of remission at 12 weeks,
- the rate of major cytogenetic response to 52 weeks
*Tolerance of the association IFN /cytosine-arabinoside |
| Secondary outcomes |
| - Delay of hematologic and cytogenetic response ,
- Duration of the hematologic response : occurrence of relapse or disease progression (acceleration, acute transformation),
- Diuration of the cytogenetic response ,
- Peobablility of survival. |
| Summary of study design, objectives, and ongoing research findings |
| The trial aims to evaluate the efficacy and tolerance of recombinant interferon-alpha 2b associated the cytosine arabinoside in patients younger than 18 years with chronic leukaemia myéloïde (CML)in chronic phase. |
