Recurrent Adult Hodgkin Lymphoma Clinical Trial
Official title:
A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine (LEBEN) in Relapsed and Primary Refractory Hodgkin Lymphoma
Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation
failure represents a typical unmet medical need prompting active development and validation
of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide
and bendamustine, framing different targets on both tumor and microenvironmental cells of
HL. These agents, while showing a low risk of overlapping extrahematologic toxicities, may
hit the proliferation machinery of H-RS cells and/or their progenitors, synergistically
inhibit tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating
in the microenvironment to support tumor cell survival.
A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous
administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a
28-day cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and
immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and
protracted doses of alkylators induce a decrease in microvascular density of tumor tissues
and inhibit mobilization and viability of circulating endothelial progenitors.
The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method
chooses doses based-on both response and toxicity, and accounts for the trade-off between
these two outcomes.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02168140 -
CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1 | |
| Completed |
NCT01902160 -
Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
|
Phase 1 | |
| 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 |
NCT01165112 -
Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
|
Phase 1/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 |
NCT00132028 -
Vorinostat in Treating Patients With Relapsed or Refractory Advanced Hodgkin's Lymphoma
|
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 |
NCT00005803 -
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT01678443 -
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
|
Phase 1 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT02240719 -
Everolimus and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory Hematologic Cancer
|
Phase 1 | |
| Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Terminated |
NCT00288067 -
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00098891 -
MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00004241 -
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma
|
Phase 1 | |
| Completed |
NCT01460940 -
A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT01476839 -
Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma
|
Phase 1 | |
| Completed |
NCT01748721 -
MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
|
Phase 1 | |
| Terminated |
NCT00101244 -
SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin's or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00105001 -
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
|
Phase 2 |