Refractory Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Phase 1/2 Trial of Pembrolizumab in Combination With Blinatumomab in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
This phase I/II studies the side effects of pembrolizumab and blinatumomab and to see how well they work in treating participants with acute lymphoblastic leukemia that has come back or has not responded to the treatment. Monoclonal antibodies, such as pembrolizumab and blinatumomab, may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of combination immunotherapy with blinatumomab and pembrolizumab by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. (Phase 1) II. Determine the recommended phase 2 schedule of combination immunotherapy with pembrolizumab and blinatumomab. (Phase 1) III. Evaluate the anti-leukemia activity of combination immunotherapy blinatumomab and pembrolizumab as assessed by overall response rate (complete response [CR] or CR with incomplete recovery [CRi]). (Phase 2) SECONDARY OBJECTIVES: I. Estimate time to response (CR or CRi) and response duration. (Phase 2) II. Estimate overall survival and event-free survival. (Phase 2) III. Determine the number and proportion of patients who underwent hematopoietic stem cell transplantation (HSCT) after treatment of pembrolizumab and blinatumomab. (Phase 2) IV. Determine the number and proportion of patients who receive pembrolizumab maintenance and the proportion continuing for up to 1 year. (Phase 2) V. Estimate the minimal residual disease rate. (Phase 2) CORRELATIVE OBJECTIVES: I. Explore evolution of T cell subsets at various points in treatment (T naive, T effector, T effector memory, T central memory, CD4, CD8). (Phase 2) II. Evaluate PD-L1 expression levels on acute lymphoblastic leukemia (ALL) blasts and blasts counts overtime. (Phase 2) III. Evaluate PD-1/PD-L1 expression on subsets of T cells. (Phase 2) IV. Evaluate the clonal evolution of leukemic blasts in response to treatment. (Phase 2) OUTLINE: Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 15 of cycle 1 and days 1 and 22 of cycles 2 -5, and blinatumomab IV on days 1-28. Treatment repeats every 35-42 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response have the option to receive blinatumomab IV for up to 4 additional cycles. After completion of study treatment, participants are followed up at 30 days and then every 3 months for 1 year. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03620058 -
CART22 Alone or in Combination With huCART19 for ALL
|
Phase 1 | |
| Completed |
NCT02551718 -
High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia
|
N/A | |
| Recruiting |
NCT04888442 -
Phase I Study of pCAR-19B in the Treatment of Adult CD19-positive Relapsed/Refractory B-ALL
|
Phase 1 | |
| Suspended |
NCT03128034 -
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03739606 -
Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer
|
Phase 2 | |
| 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 | |
| Active, not recruiting |
NCT02146924 -
Cellular Immunotherapy in Treating Patients With High-Risk Acute Lymphoblastic Leukemia
|
Phase 1 | |
| Recruiting |
NCT04000698 -
Personalized Targeted Preparative Regimen Before T-depleted Allogeneic HSCT in Children With Chemoresistent Acute Leukemias
|
Phase 3 | |
| Completed |
NCT03096782 -
Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
|
Phase 2 | |
| Completed |
NCT03575325 -
Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Completed |
NCT04888468 -
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
|
Phase 1 | |
| Terminated |
NCT03094611 -
Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Recruiting |
NCT02392572 -
ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03263572 -
Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Terminated |
NCT03519984 -
EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia
|
Phase 1 | |
| Completed |
NCT04562792 -
Low Dose Daunorubicin in Pediatric Relapsed/Refractory Acute Leukemia
|
Phase 2 | |
| Active, not recruiting |
NCT01619761 -
NK Cells in Cord Blood Transplantation
|
Phase 1 | |
| Completed |
NCT01865617 -
Laboratory Treated T Cells in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or Acute Lymphoblastic Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02727803 -
Personalized NK Cell Therapy in CBT
|
Phase 2 | |
| Terminated |
NCT01620216 -
Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
|
Phase 2 |