Minimal Residual Disease Clinical Trial
Official title:
Phase II Study of Blinatumomab in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. To evaluate the clinical efficacy of blinatumomab in patients B-cell acute lymphoblastic leukemia in complete morphologic remission with positive minimal residual disease (MRD) in terms of relapse-free survival (RFS). SECONDARY OBJECTIVES: I. To evaluate other efficacy endpoints such as overall survival and MRD negativity rate by flow cytometry and/or polymerase chain reaction (PCR) overall and after the first cycle, as well as safety of blinatumomab in this setting. OUTLINE: Patients receive blinatumomab intravenously (IV) continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received. After completion of study treatment, patients are followed up every 6 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04044560 -
Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant
|
Phase 2 | |
| Recruiting |
NCT05959720 -
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
|
||
| Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT03233854 -
CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06358430 -
Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD)
|
Phase 1 | |
| Not yet recruiting |
NCT05603156 -
A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive
|
N/A | |
| Withdrawn |
NCT03699384 -
Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05601830 -
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
|
Phase 1 | |
| Recruiting |
NCT06066905 -
A Study of Chidamide With AZA in MRD Positive AML After Transplant
|
N/A | |
| Terminated |
NCT03272633 -
Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies
|
Early Phase 1 | |
| Recruiting |
NCT03241940 -
Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
|
Phase 1 | |
| Completed |
NCT03096782 -
Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
|
Phase 2 | |
| Completed |
NCT05093192 -
Mobilising Tumour and Immune Cells Via Exercise in Chronic Lymphocytic Leukaemia
|
N/A | |
| Recruiting |
NCT06230185 -
ctDNA Based MRD Testing for NAC Monitoring in TNBC
|
||
| Recruiting |
NCT02400827 -
Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors
|
N/A | |
| Recruiting |
NCT02400970 -
Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors
|
N/A | |
| Active, not recruiting |
NCT01894477 -
Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
|
Phase 2 | |
| Active, not recruiting |
NCT04920188 -
Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)
|
||
| Completed |
NCT02714790 -
Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia
|
N/A |