Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003790
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
1999-11-01
Brief Title:
Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Detection of Minimal Residual Disease in Children Receiving Therapy for AML or MDS
Status:
COMPLETED
Status Verified Date:
2014-08
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 Diagnostic procedures may improve the ability to detect residual disease
PURPOSE Clinical trial to detect the presence of residual disease in children who are receiving therapy for acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Clinical trial to detect the presence of residual disease in children who are receiving therapy for acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the frequency and prognostic significance of persistent abnormal cells with an aberrant phenotype detected by multidimensional flow cytometry MDF in bone marrow samples from children who have achieved clinical remission after receiving treatment for acute myeloid leukemia or myelodysplastic syndrome II Compare the frequency of persistent abnormal cells obtained by MDF with that of polymerase chain reaction PCR morphologic and cytogenetic analyses of these patient samples III Determine the frequency and prognostic significance of persistent abnormal cells with a leukemia-specific molecular marker detected by PCR in samples from these patients
OUTLINE Patients have bone marrow samples collected during the course of therapy on the CCG 2961 acute myeloid leukemia treatment protocol These samples are collected 1 At the time of diagnosis 2 At the end of induction within a week of day 35 3 At the end of consolidation before bone marrow transplant or Capizzi 2 4 Before and after interleukin-2 IL-2 therapy if applicable 5 At the end of therapy after transplant with evidence of engraftment for autologous bone marrow transplant patients after course 2 of intensification for chemotherapy patients and after IL-2 day 21 for IL-2 patients 6 At relapse if applicable The presence of minimal residual disease in bone marrow is assessed using multidimensional flow cytometry and PCR
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
OUTLINE Patients have bone marrow samples collected during the course of therapy on the CCG 2961 acute myeloid leukemia treatment protocol These samples are collected 1 At the time of diagnosis 2 At the end of induction within a week of day 35 3 At the end of consolidation before bone marrow transplant or Capizzi 2 4 Before and after interleukin-2 IL-2 therapy if applicable 5 At the end of therapy after transplant with evidence of engraftment for autologous bone marrow transplant patients after course 2 of intensification for chemotherapy patients and after IL-2 day 21 for IL-2 patients 6 At relapse if applicable The presence of minimal residual disease in bone marrow is assessed using multidimensional flow cytometry and PCR
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066930 | OTHER | Clinical Trialsgov | None |
| CCG-B942 | OTHER | None | None |