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Monoclonal Antibodies

Vemurafenib plus Obinutuzumab for Hairy Cell Leukemia

Phase 2
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients must be ≥ 18 years of age
* Histologically confirmed classical HCL by the enrolling institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.

Who is the study for?
This trial is for individuals with Hairy Cell Leukemia. Participants should not have had previous treatments for this condition and must be suitable candidates for the drug interventions being tested.
What is being tested?
The study compares two treatment approaches: Vemurafenib with Obinutuzumab versus Cladribine with Rituximab. The goal is to determine which combination has fewer side effects and is more effective in eliminating cancer cells.
What are the potential side effects?
Potential side effects may include common reactions like nausea, fatigue, skin rash or more serious conditions such as liver problems or infections due to weakened immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
incidences of ≥ grade 3 treatment-related toxicities
Secondary study objectives
complete remission
partial response

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vemurafenib plus ObinutuzumabExperimental Treatment2 Interventions
Patients assigned to the study arm will receive vemurafenib 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 on days 1, 8 and 15 during the cycle 2 and every 4 weeks during the cycle 3 and 4 of treatment.
Group II: Standard treatment of Cladribine plus RituximabActive Control2 Interventions
Patients assigned to the SOC arm will receive cladribine IV on days 1-5 concurrently with rituximab IV per week for 8 times, i.e., weekly x8 from day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3540
Obinutuzumab
2014
Completed Phase 3
~3470

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,954 Previous Clinical Trials
597,428 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,547 Previous Clinical Trials
568,254 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
15 Previous Clinical Trials
485 Total Patients Enrolled
~57 spots leftby Aug 2027
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