Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003593
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Children With Down Syndrome and Myeloproliferative Disorder Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Children With Down Syndrome DS and Acute Myeloid Leukemia AML Myelodysplastic Syndrome MDS and Transient Myeloproliferative Disorder TMD A Phase III Group-Wide Study
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder acute myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating children who have Down syndrome and myeloproliferative disorder acute myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Evaluate the efficacy of reduced-dose induction and intensification chemotherapy in terms of remission rate disease-free survival rate and acute morbidity and mortality in children with Down syndrome and acute myelogenous leukemia or myelodysplastic syndromes
Define the understanding of the natural history of transient myeloproliferative disorder TMD in children with Down syndrome
Determine whether there is a reduction of sequelae in long-term survivors after treatment with this regimen
Determine the incidence of subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen
Determine the predictive risk factors for developing subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen
OUTLINE This is a multicenter study
Group I Patients are observed if their transient myeloproliferative disorder TMD does not require intervention Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days If the TMD does not resolve or there is significant organ involvement patients receive low-dose cytarabine IV continuously on days 0-4 Treatment repeats at least every 2 weeks for up to 4 courses Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment
Group II closed to accrual as of 62404 except for patients first enrolled in group I Patients receive induction therapy comprising cytarabine IV continuously daunorubicin IV continuously and oral thioguanine twice daily on days 0-3 Treatment repeats every 28 days for 4 courses Patients with no CNS disease at diagnosis receive cytarabine intrathecally IT on day 0 Patients with CNS disease at diagnosis receive cytarabine IT on days 0 5 and 7 If CNS disease persists on day 7 patients receive up to 6 courses of cytarabine IT hydrocortisone IT and methotrexate IT twice weekly beginning on day 10
Patients who achieve remission after induction therapy receive 2 courses of intensification therapy for approximately 4 months During the first course patients receive cytarabine IV over 3 hours twice daily on days 0 1 7 and 8 Patients also receive asparaginase intramuscularly on days 1 and 8 The second course of therapy comprises CNS prophylaxis Patients with no CNS disease at diagnosis or whose CNS disease resolved by day 7 of induction therapy receive cytarabine IT on days 0 7 and 14 Patients with persistent CNS disease on day 7 of induction therapy receive cytarabine IT hydrocortisone IT and methotrexate IT on days 0 7 and 14
Patients are followed monthly for 18 months every 3 months for 1 year every 6 months for 25 years and then annually thereafter
PROJECTED ACCRUAL A total of 70 patients with acute myeloid leukemia or myelodysplastic syndromes will be accrued for this study within 32 years A total of 88 patients with transient myeloproliferative disorder who enter remission will be accrued for this study within 5 years
Evaluate the efficacy of reduced-dose induction and intensification chemotherapy in terms of remission rate disease-free survival rate and acute morbidity and mortality in children with Down syndrome and acute myelogenous leukemia or myelodysplastic syndromes
Define the understanding of the natural history of transient myeloproliferative disorder TMD in children with Down syndrome
Determine whether there is a reduction of sequelae in long-term survivors after treatment with this regimen
Determine the incidence of subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen
Determine the predictive risk factors for developing subsequent leukemia in patients with transient myeloproliferative disorder treated with this regimen
OUTLINE This is a multicenter study
Group I Patients are observed if their transient myeloproliferative disorder TMD does not require intervention Patients who require therapy for TMD undergo leukapheresis or exchange transfusion for up to 3 consecutive days If the TMD does not resolve or there is significant organ involvement patients receive low-dose cytarabine IV continuously on days 0-4 Treatment repeats at least every 2 weeks for up to 4 courses Patients who experience a recurrence of TMD at least 8 weeks after resolution or have refractory disease may proceed to group II for further treatment
Group II closed to accrual as of 62404 except for patients first enrolled in group I Patients receive induction therapy comprising cytarabine IV continuously daunorubicin IV continuously and oral thioguanine twice daily on days 0-3 Treatment repeats every 28 days for 4 courses Patients with no CNS disease at diagnosis receive cytarabine intrathecally IT on day 0 Patients with CNS disease at diagnosis receive cytarabine IT on days 0 5 and 7 If CNS disease persists on day 7 patients receive up to 6 courses of cytarabine IT hydrocortisone IT and methotrexate IT twice weekly beginning on day 10
Patients who achieve remission after induction therapy receive 2 courses of intensification therapy for approximately 4 months During the first course patients receive cytarabine IV over 3 hours twice daily on days 0 1 7 and 8 Patients also receive asparaginase intramuscularly on days 1 and 8 The second course of therapy comprises CNS prophylaxis Patients with no CNS disease at diagnosis or whose CNS disease resolved by day 7 of induction therapy receive cytarabine IT on days 0 7 and 14 Patients with persistent CNS disease on day 7 of induction therapy receive cytarabine IT hydrocortisone IT and methotrexate IT on days 0 7 and 14
Patients are followed monthly for 18 months every 3 months for 1 year every 6 months for 25 years and then annually thereafter
PROJECTED ACCRUAL A total of 70 patients with acute myeloid leukemia or myelodysplastic syndromes will be accrued for this study within 32 years A total of 88 patients with transient myeloproliferative disorder who enter remission will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066664 | OTHER | Clinical Trialsgov | None |
| COG-A2971 | OTHER | None | None |
| CCG-A2971 | OTHER | None | None |
| POG-A2971 | OTHER | None | None |
| CCG-29701 | OTHER | None | None |