Lymphoma, Non-Hodgkin Clinical Trial
Official title:
An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies
Verified date | December 2014 |
Source | Seattle Genetics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.
Status | Completed |
Enrollment | 52 |
Est. completion date | August 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Relapsed or refractory CD30-positive malignancy - Adequate organ function - ECOG performance status <2 Exclusion Criteria: - Cardiac abnormalities (abnormal rhythm, history of significant cardiac event) - Current diagnosis of primary cutaneous ALCL - Acute or chronic graft-versus-host disease - Prior hematopoietic stem cell transplant within specified timeframe |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Cologne | Koln | |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Baylor University Medical Center | Dallas | Texas |
United States | City of Hope National Medical Center | Duarte | California |
United States | Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois |
United States | University of Miami Hospital and Clinics, Miller School of Medicine | Miami | Florida |
United States | New York University Cancer Institute | New York | New York |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Stanford Cancer Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Seattle Genetics, Inc. | Millennium Pharmaceuticals, Inc. |
United States, Germany,
Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancie — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QTc interval | 2-4 days postdose | Yes | |
Secondary | ECG parameters | 2-4 days postdose | No | |
Secondary | Blood MMAE levels | Through 4 days postdose | No | |
Secondary | Incidence of proarrhythmic adverse events | Through 1 month following last dose | Yes | |
Secondary | Incidence of adverse events and laboratory abnormalities | Through 1 month following last dose | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT03484702 -
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
|
Phase 2 | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
Completed |
NCT06190457 -
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
|
||
Completed |
NCT02369016 -
Phase III Copanlisib in Rituximab-refractory iNHL
|
Phase 3 | |
Recruiting |
NCT01676805 -
Tissue Collection for Studies of Lymph Cancer
|
||
Terminated |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
Terminated |
NCT00529503 -
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
|
Phase 2 | |
Withdrawn |
NCT00538096 -
A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma
|
Phase 1 | |
Completed |
NCT00534989 -
Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT
|
N/A | |
Completed |
NCT00156013 -
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00322842 -
Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
|
Phase 2 | |
Completed |
NCT00141297 -
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT02509039 -
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
|
Phase 1 | |
Completed |
NCT01573000 -
A Randomized Study of Iodine-131 Anti-b1 Antibody Versus Anti-b1 Antibody in Chemotherapy-relapsed/Refractory Low-grade or Transformed Low-grade Non-Hodgkin's Lymphoma (NHL)
|
Phase 2 | |
Completed |
NCT00268203 -
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT03289182 -
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
|