Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
A Phase I Study of Buparlisib (BKM120) and Ofatumumab or Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This phase I trial studies the side effects and best dose of buparlisib when given together with ofatumumab or ibrutinib in treating patients with chronic lymphocytic leukemia that has returned after a period of improvement or does not respond to treatment. Buparlisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as ofatumumab, may block cancer growth in different ways by targeting certain cells. Giving buparlisib or ibrutinib and ofatumumab together may work better in treating patients with chronic lymphocytic leukemia.
PRIMARY OBJECTIVES:
I. To evaluate the safety and dose limiting toxicities (DLT) of combined ofatumumab and
buparlisib in patients with previously treated chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL) who have been exposed to ibrutinib (i.e., ibrutinib pre-treated).
II. To evaluate the safety and dose limiting toxicities (DLT) of combined ibrutinib and
buparlisib in patients with previously treated chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL) who have NOT been exposed to ibrutinib (i.e., ibrutinib naïve)
SECONDARY OBJECTIVES:
I. To determine specific toxicities associated with combined buparlisib and ofatumumab.
II. Evaluate for efficacy of buparlisib in combination with ofatumumab in ibrutinib
pre-treated patients with CLL/SLL.
III. To determine specific toxicities associated with combined buparlisib and ibrutinib.
IV. To evaluate for efficacy of buparlisib in combination with ibrutinib in ibrutinib naive
patients with CLL/SLL.
OUTLINE: This is a dose escalation study of buparlisib. Patients are assigned to 1 of 2
treatment cohorts.
COHORT A (ibrutinib pre-treated): Patients receive buparlisib orally (PO) once daily (QD) on
days 1-28 and ofatumumab intravenously (IV) on days 1, 8, 15, and 22 during of courses 1-2;
and day 1 of courses 4-7. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
COHORT B (ibrutinib naive): Patients receive buparlisib as in Cohort A and ibrutinib PO on
days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
;
| 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 | |
| Completed |
NCT02254772 -
A Phase I/II Study of Intratumoral Injection of SD-101
|
Phase 1/Phase 2 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| 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 |