Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
A Phase 2 Study of MK-2206 in Patients With Relapsed or Refractory Diffuse Large-B Cell Lymphoma
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective
response rate (ORR) at 4 months (complete response [CR], and partial response [PR]) as per
the 2007 International Cheson response criteria.
SECONDARY OBJECTIVES:
I. To evaluate the antitumor activity of MK2206 in terms of ORR at 4 months (CR, unconfirmed
complete response [CRu], and PR) as per the 1999 International Cheson response criteria.
II. To determine the duration of response, defined as the time from the date of the best
response to the date of progression.
III. To determine the progression-free survival and overall survival of these patients.
IV. To determine the safety of MK2206. V. To identify predictive biomarkers for treatment
outcome. (exploratory) VI. To conduct a pharmacodynamic study using FDG-PET scans.
(exploratory)
OUTLINE: This a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) once weekly on days 1, 8, 15, and 22.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04670029 -
Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line
|
Phase 3 | |
| Active, not recruiting |
NCT04572763 -
Copanlisib Plus Venetoclax in R/R DLBCL
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04526834 -
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
|
Phase 1 | |
| Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
| Completed |
NCT03287817 -
CD19/22 CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT05645744 -
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
|
||
| Completed |
NCT04316624 -
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
|
Phase 1 | |
| Active, not recruiting |
NCT04555811 -
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
|
Phase 1 | |
| Terminated |
NCT04189952 -
Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma
|
Phase 2 | |
| Recruiting |
NCT01949818 -
Treatment of Diffuse Large B Cell Lymphoma
|
Phase 4 | |
| Completed |
NCT01459887 -
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
|
Phase 3 | |
| Completed |
NCT03242902 -
To Decrease Fatigue With Light Therapy
|
Phase 3 | |
| Recruiting |
NCT04104776 -
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05018520 -
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
|
Phase 3 | |
| Withdrawn |
NCT04052061 -
QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT05020392 -
Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma
|
Phase 3 | |
| Recruiting |
NCT05006716 -
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT03297424 -
A Study of PLX2853 in Advanced Malignancies.
|
Phase 1 | |
| Recruiting |
NCT04545762 -
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
|
Phase 1 |