A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in

Status Active, not recruiting

Clinical Trial Summary

This is a multi-center, open label, single arm, phase II trial of the oral BRAF inhibitor, vemurafenib, plus obinutuzumab in patients with previously untreated HCL. A Simon mini-max two-stage design will be employed to assess the efficacy of the combination treatment of vemurafenib and obinutuzumab. In the first stage of the protocol, 9 patients will be treated. If fewer than 6 CRs are seen among the first 9 patients, the study will be closed for lack of efficacy. If at least 7 patients respond to the treatment, then an additional 19 patients will be accrued to the second stage, for a total of 28 patients. Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles. Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks. Obinutuzumab infusions will be administered at 1000mg per day on days 1, 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3 and 4 of treatment. After the completion of the treatment (i.e. after 4 cycles), a bone marrow aspirate and biopsy will be performed for assessment of response and evaluation of minimal residual disease (MRD). In case of certain defined toxicities, dose reductions of vemurafenib by 50% (480mg b.i.d.) or interruptions of up to 15 days are permitted. If additional dose reduction is required, vemurafenib may be reduced to 240mg oral b.i.d.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03410875
Study type	Interventional
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	February 9, 2018
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05691608` - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2	N/A
Recruiting	`NCT04092803` - Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu	N/A
Active, not recruiting	`NCT02530463` - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome	Phase 2
Completed	`NCT00948064` - Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)	Phase 2
Completed	`NCT04474678` - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")	N/A
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Recruiting	`NCT03948529` - RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation	Phase 2
Completed	`NCT01682226` - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies	Phase 2
Completed	`NCT00003270` - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer	Phase 2
Active, not recruiting	`NCT02723994` - A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia	Phase 2
Terminated	`NCT02469415` - Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)	Phase 2
Recruiting	`NCT04856215` - 90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia	Phase 2
Recruiting	`NCT06155188` - Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia	N/A
Completed	`NCT00001637` - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults	Phase 2
Active, not recruiting	`NCT04188678` - Resiliency in Older Adults Undergoing Bone Marrow Transplant	N/A
Completed	`NCT02910583` - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)	Phase 2
Completed	`NCT01212926` - Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain	N/A
Terminated	`NCT00014560` - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia	Phase 1
Recruiting	`NCT04977024` - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer	Phase 2
Recruiting	`NCT05866887` - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia	N/A

A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms