Leukemia Clinical Trial
Official title:
Validation of a Classifier for Induction Response Prediction Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may
help doctors predict how well patients will respond to treatment.
PURPOSE: This research trial is studying biomarkers in predicting response to treatment in
bone marrow samples from young patients with acute myeloid leukemia.
OBJECTIVES:
Primary
- To validate the accuracy of a pre-specified acute myeloid leukemia (AML) induction
response classifier or the My Profileā¢ AML Induction Therapy Assay (run in a Good
Laboratory Practice [GLP] laboratory using Good Manufacturing Practice [GMP] reagents)
in predicting response to cytarabine-based induction chemotherapy in pediatric patients
with non-M3 AML.
Secondary
- To validate the continuous score from the pre-specified induction response classifier
as a predictor of response to induction chemotherapy, after controlling for the
simultaneous effects of clinical variables at base-line and/or pre-induction therapy
(e.g., age, WBC, and percentage [%] of blasts), and tests commonly available after the
start of induction therapy (e.g., cytogenetics and molecular markers).
- To validate the accuracy of the pre-specified induction response classifier as a binary
predictor of induction response using a pre-specified cutpoint to assign patients to no
response (NR) or complete response (CR) groups.
- To validate the accuracy of the pre-specified induction response classifier as a binary
predictor of induction response using a pre-specified cutpoint to assign patients to NR
or CR groups, after controlling for the simultaneous effects of clinical variables at
base-line (pre-induction therapy) (e.g., age, WBC, % blasts) and clinical variables,
including tests commonly available after start of induction therapy (e.g., age, WBC,
cytogenetics).
OUTLINE: Cryopreserved bone marrow mononuclear cell specimens are analyzed by cell
networking profiling assays. Results are then compared with patient outcomes and
demographics from COG-AAML03P1 and COG-AAML0531 studies.
Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.
;
Observational Model: Cohort, Time Perspective: Retrospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Recruiting |
NCT04092803 -
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
|
N/A | |
Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT00948064 -
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT03948529 -
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation
|
Phase 2 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02723994 -
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
|
Phase 2 | |
Terminated |
NCT02469415 -
Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 | |
Recruiting |
NCT04856215 -
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
|
Phase 2 | |
Recruiting |
NCT06155188 -
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
|
N/A | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
Completed |
NCT01212926 -
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A |