Refractory Hodgkin Lymphoma Clinical Trial
Official title:
A Phase I Trial of Brentuximab Vedotin Plus MDR1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma
This phase I trial studies the side effects and best dose of brentuximab vedotin and cyclosporine when given together with verapamil hydrochloride in treating patients with Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunosuppressive therapies, such as cyclosporine, may improve bone marrow function and increase blood cell counts. Verapamil hydrochloride may increase the effectiveness of brentuximab vedotin by overcoming drug resistance of the cancer cells. Giving brentuximab vedotin, cyclosporine, and verapamil hydrochloride may work better in treating patients with Hodgkin lymphoma.
PRIMARY OBJECTIVE: I. Evaluate the safety and tolerability of the combination of brentuximab vedotin (BV) plus MDR1 inhibitors cyclosporine (CsA)/verapamil hydrochloride (verapamil [VRP]). SECONDARY OBJECTIVES: I. Obtain estimates of overall response rate (ORR), complete response (CR) rate, and response duration in patients treated with the combination of BV plus CsA/VRP. II. Estimate overall and progression-free survival in patients treated with the combination of BV plus CsA/VRP. III. Characterize pharmacokinetics of plasma monomethyl auristatin E (MMAE) in cycle 1 (for expansion cohort only). OUTLINE: This is a dose-escalation study of brentuximab vedotin and cyclosporine. Patients receive cyclosporine orally (PO) twice daily (BID) on days 1-5, verapamil hydrochloride PO four times daily (QID) on days 1-5, and brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients who have not progressed are followed up every 6 months until disease progression, start of a new lymphoma therapy, 2 years post treatment, or study completion, whichever is earlier. Patients who progress are followed up periodically. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00005803 -
Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03259503 -
Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant
|
Phase 1 | |
| Completed |
NCT04052997 -
Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04134325 -
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma
|
Early Phase 1 | |
| Completed |
NCT01921387 -
Radiolabeled Monoclonal Antibody and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With High-Risk Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01701986 -
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT00075478 -
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
|
Phase 3 | |
| Withdrawn |
NCT03739606 -
Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer
|
Phase 2 | |
| Completed |
NCT01393717 -
Brentuximab Vedotin Before Autologous Stem Cell Transplant in Treating Patients With Hodgkin Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05595447 -
Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
|
Phase 2/Phase 3 | |
| Completed |
NCT00789776 -
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02227199 -
Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05272384 -
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT03739619 -
Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02869633 -
Ibrutinib in Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01231412 -
Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant
|
Phase 3 | |
| Recruiting |
NCT04871607 -
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT04681105 -
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT03213665 -
Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)
|
Phase 2 | |
| Active, not recruiting |
NCT01619761 -
NK Cells in Cord Blood Transplantation
|
Phase 1 |