Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047268
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2002-10-03
Brief Title:
Donor Stem Cell Transplant With or Without Chemotherapy in Treating Children With Primary Myelodysplastic Syndrome
Sponsor:
European Working Group of MDS in Childhood
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Prospective Study of the Diagnosis and Treatment of Myelodysplastic Syndromes MDS in Childhood
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Giving chemotherapy before a donor stem cell transplant helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets It is not yet known whether donor stem cell transplant is more effective with or without chemotherapy in treating primary myelodysplastic syndrome
PURPOSE This phase III trial is studying how well donor stem cell transplant given with chemotherapy works and compares it with donor stem cell transplant without chemotherapy in treating children with primary myelodysplastic syndrome
PURPOSE This phase III trial is studying how well donor stem cell transplant given with chemotherapy works and compares it with donor stem cell transplant without chemotherapy in treating children with primary myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine by a standard approach the frequency of different FAB subtypes in children with primary myelodysplastic syndromes
Determine the frequency of cytogenetic and molecular abnormalities in these patients
Determine the survival of patients treated with allogeneic stem cell transplantation with or without induction chemotherapy
Determine the rate of complete remission in patients treated with these regimens
Determine the event-free survival of patients treated with these regimens
Determine the relapse rate morbidity and mortality of patients treated with these regimens
Determine different subsets of patients who benefit from these regimens
OUTLINE This is a multicenter study Patients are stratified according to FAB subtype refractory anemia RA or RA with ringed sideroblasts RARS vs RA with excess blasts RAEB vs RAEB in transformation RAEB-t vs juvenile myelomonocytic leukemia JMML
Patients undergo complete medical and physical examination Patients are screened for the following aberrations -7 8 21 t821 t1517 and inv16 Smears of peripheral blood and bone marrow as well as bone marrow biopsies and all cytogenetic and molecular studies performed on blood or bone marrow are evaluated by a panel of international experts
Patients with progressive RA or RARS undergo allogeneic stem cell transplantation ASCT according to EWOG-MDS SCT studies Patients with stable RA or RARS wait for an optimal donor before undergoing ASCT Patients with RAEB with fewer than 15 bone marrow blasts undergo ASCT Patients with RAEB with at least 15 bone marrow blasts and patients with RAEB-t with fewer than 30 bone marrow blasts receive standard acute myeloid leukemia AML induction therapy and then undergo ASCT Patients with RAEB-t with at least 30 bone marrow blasts are considered for standard AML induction therapy
Patients with advanced JMML undergo evaluation for splenectomy and receive chemotherapy with mercaptopurine and cytarabine every 3-4 weeks for 1-4 doses Patients then undergo ASCT
Patients are followed every 6 months
PROJECTED ACCRUAL Not specified
Determine by a standard approach the frequency of different FAB subtypes in children with primary myelodysplastic syndromes
Determine the frequency of cytogenetic and molecular abnormalities in these patients
Determine the survival of patients treated with allogeneic stem cell transplantation with or without induction chemotherapy
Determine the rate of complete remission in patients treated with these regimens
Determine the event-free survival of patients treated with these regimens
Determine the relapse rate morbidity and mortality of patients treated with these regimens
Determine different subsets of patients who benefit from these regimens
OUTLINE This is a multicenter study Patients are stratified according to FAB subtype refractory anemia RA or RA with ringed sideroblasts RARS vs RA with excess blasts RAEB vs RAEB in transformation RAEB-t vs juvenile myelomonocytic leukemia JMML
Patients undergo complete medical and physical examination Patients are screened for the following aberrations -7 8 21 t821 t1517 and inv16 Smears of peripheral blood and bone marrow as well as bone marrow biopsies and all cytogenetic and molecular studies performed on blood or bone marrow are evaluated by a panel of international experts
Patients with progressive RA or RARS undergo allogeneic stem cell transplantation ASCT according to EWOG-MDS SCT studies Patients with stable RA or RARS wait for an optimal donor before undergoing ASCT Patients with RAEB with fewer than 15 bone marrow blasts undergo ASCT Patients with RAEB with at least 15 bone marrow blasts and patients with RAEB-t with fewer than 30 bone marrow blasts receive standard acute myeloid leukemia AML induction therapy and then undergo ASCT Patients with RAEB-t with at least 30 bone marrow blasts are considered for standard AML induction therapy
Patients with advanced JMML undergo evaluation for splenectomy and receive chemotherapy with mercaptopurine and cytarabine every 3-4 weeks for 1-4 doses Patients then undergo ASCT
Patients are followed every 6 months
PROJECTED ACCRUAL Not specified
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20218 | None | None | None |
| EWOG-MDS-98 | None | None | None |