Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
A Phase I Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Leukemia (PLL)
RATIONALE:
Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for
cell growth.
PURPOSE:
This phase I trial is studying the side effects and the best dose of carfilzomib in treating
patients with relapsed or refractory chronic lymphocytic leukemia(CLL),small lymphocytic
lymphoma(SLL), or prolymphocytic leukemia (PLL).
PRIMARY OBJECTIVES:
I. To determine the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of
carfilzomib in patients with relapsed or refractory Chronic Lymphocytic Leukemia(CLL) /
Small Lymphocytic Lymphoma (SLL) and Prolymphocytic Leukemia (PLL).
II. To evaluate the safety and toxicity profile of carfilzomib in relapsed or refractory
chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia
(PLL).
SECONDARY OBJECTIVES:
I. To evaluate efficacy of carfilzomib therapy in relapsed or refractory chronic lymphocytic
leukemia (CLL)/small lymphocytic leukemia (SLL)/prolymphocytic leukemia (PLL) to justify
future phase II studies.
II. To determine the degree and duration of cellular proteosome inhibition induced by
carfilzomib and relationship of this to pharmacodynamics, response and toxicity.
III. To determine the pharmacokinetics (plasma and cellular) of carfilzomib and relationship
of this to proteosome inhibition, pharmacodynamics, response, and toxicity.IV. To examine
the effect of carfilzomib on pharmacodynamic parameters including cytokines, changes in
downstream targets including NF-kappa B (p50/p65 binding; I-kappa B level, P-I-kappa B
level,select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target
genes), ER stress proteins, and p73.
OUTLINE: This is a dose-escalation study of carfilzomib.Patients receiving carfilzomib
intra-venous(IV) over 30 minutes once daily, on days 1, 2, 8, 9, 15, and 16. Treatment
repeats every 28 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03045328 -
Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL
|
Phase 2 | |
Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
Active, not recruiting |
NCT02153580 -
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
|
Phase 1 | |
Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
Completed |
NCT02254772 -
A Phase I/II Study of Intratumoral Injection of SD-101
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01369849 -
Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT01427881 -
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
|
Phase 2 | |
Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT00006473 -
Oxaliplatin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT00005803 -
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
|
Phase 1/Phase 2 | |
Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
Active, not recruiting |
NCT04230304 -
Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study
|
Phase 2 | |
Recruiting |
NCT03246906 -
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
|
Phase 2 | |
Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
Active, not recruiting |
NCT01815749 -
Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma
|
Phase 1 | |
Recruiting |
NCT04007029 -
Modified Immune Cells (CD19/CD20 CAR-T Cells) in Treating Patients With Recurrent or Refractory B-Cell Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04892277 -
CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 |