Waldenström Macroglobulinemia Clinical Trial
Official title:
Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia
This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of Waldenstrom's macroglobulinemia.
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) and recommended dosing for Genasense in
patients with relapsed or refractory WM following prior chemotherapy. (Phase I) II. To
determine the response rate to Genasense in patients with relapsed or refractory WM
following prior chemotherapy.
III. To determine the safety of Genasense in patients with relapsed or refractory WM
following prior chemotherapy.
IV. To describe possible clinical benefit from Genasense treatment of relapsed or refractory
WM including duration of response, survival, erythropoietin use, improvement in hemoglobin >
11 g/dl, and Improvement in platelet count > 100,000/mm^3.
OUTLINE: This is a multicenter, dose-escalation study.
Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3
weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of oblimersen until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are
followed every 3 months for 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| 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 |
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 |
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 | |
| Recruiting |
NCT05006716 -
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
|
Phase 1/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 | |
| Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT02933320 -
BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02281279 -
Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT01408043 -
Etoposide, Filgrastim, and Plerixafor in Improving Stem Cell Mobilization in Treating Patients With Non-Hodgkin Lymphoma
|
N/A | |
| Terminated |
NCT00288067 -
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00118170 -
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
|
Phase 1 | |
| Completed |
NCT00098891 -
MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT03187262 -
A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
|
Phase 2 | |
| 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 | |
| Terminated |
NCT00096005 -
Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00040846 -
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A |