Clinical Trials Logo

Clinical Trial Summary

The purpose of this research study is to assess the overall response rate of LBH589 in patients with relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly discovered compound that has killed Waldenstrom cells in laboratory studies, however, it is not known if LBH589 will show the same activity in people with Waldenstrom's Macroglobulinemia. This drug has been used in research for the treatment of other types of cancer, such as multiple myeloma.


Clinical Trial Description

This phase II study is designed to assess the toxicity profile and the proportion of overall response in patients with relapsed or refractory WM. This will study the effect of single agent LBH589 on response in these patients. Efficacy measures will include both objective clinical measurements and investigator-reported outcomes. Response and time to event analyses will follow the criteria set forth in the International Waldenstrom consortium recommendations. Prior to the start of the study, investigators will assess disease and perform a CT scan of the chest, abdomen and pelvis. Response will be assessed after 2 cycles. If patients have stable disease or response, then they will continue on therapy until progression or unacceptable toxicity, being assessed every cycle until the sixth cycle and then every 3 months. Patients who show progression after 2 cycles will come off therapy and undergo event monitoring every 3 months. All responses will be assessed by M-protein quantification and immunofixation from serum and IgM monoclonal protein level. In addition, BM biopsies will be done at baseline, at the end of cycle 6 and at the end of all therapy. The protocol was amended because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00936611
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date November 2012

See also
  Status Clinical Trial Phase
Completed NCT02566265 - Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients Phase 2
Completed NCT00422656 - Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00150462 - Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Phase 1
Completed NCT00165295 - Sildenafil Citrate in Waldenstrom's Macroglobulinemia Phase 2
Terminated NCT00142168 - CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
Suspended NCT02439138 - Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Phase 2
Completed NCT01470196 - Carfilzomib, Rituximab and Dexamethasone in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00250926 - Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Phase 2
Terminated NCT03225716 - A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia Phase 1
Terminated NCT01744912 - Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies Phase 1
Completed NCT02363439 - Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 Phase 1/Phase 2
Completed NCT00976248 - Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia Phase 2
Terminated NCT00575965 - Simvastatin in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT00919139 - S0309, Repository: Blood/Bone Marrow From Pts. With Myeloma, WM, Amyloidosis, or MGUS. N/A
Completed NCT01614821 - Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia Phase 2
Active, not recruiting NCT01078974 - Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia Phase 1
Completed NCT00481871 - Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies Phase 1/Phase 2
Completed NCT00142116 - Thalidomide and Rituximab in Waldenstrom's Macroglobulinemia Phase 2
Completed NCT02092909 - Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia Phase 1/Phase 2
Completed NCT00807677 - A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies Phase 1