Acute Leukemia Clinical Trial
Official title:
Evaluation of the BD OneFlow Acute Leukemia Panel (BD OneFlow ALOT, BCP-ALL T1, and AML T1-T4) on the BD FACSLyric Flow Cytometer Using Leftover, De-identified Specimens
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.
Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis. Currently, there are no consensus panels being used; consequently, the leukemia & lymphoma (L&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed. Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts . The final diagnosis and the affected cell population will be determined by site standard of care . Analysis of data will evaluate identification of 1) normal vs abnormal cell populations and 2) BCP-ALL, AML, and less certain diseases by the expert & site analysts as compared to the final diagnosis. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Active, not recruiting |
NCT01956630 -
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
|
Phase 1/Phase 2 | |
| Completed |
NCT00988013 -
Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies
|
N/A | |
| Enrolling by invitation |
NCT01728402 -
Pathogenesis of Hematologic Malignancies
|
||
| Active, not recruiting |
NCT03595800 -
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
|
Phase 3 | |
| Completed |
NCT02440178 -
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
|
Phase 2 | |
| Recruiting |
NCT05071482 -
Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
|
Phase 4 | |
| Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
| Completed |
NCT03042676 -
Electronic Database for the Follow up of the ATG_FamilyStudy
|
||
| Completed |
NCT04597086 -
Bright White Light Therapy for the Improvement of Sleep, Fatigue, Distress, Depression, and Anxiety in Hospitalized Leukemia Patients
|
N/A | |
| Terminated |
NCT03588936 -
Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant
|
Phase 1 | |
| Recruiting |
NCT05521204 -
Olverembatinib for FGFR1-rearranged Neoplasms
|
Phase 2 | |
| Not yet recruiting |
NCT04084327 -
Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
|
||
| Terminated |
NCT00852709 -
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias
|
Phase 1 | |
| Not yet recruiting |
NCT06026839 -
Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors
|