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Monoclonal Antibodies

Vemurafenib + Obinutuzumab vs Cladribine + Rituximab 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
Must not have
Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)
Active uncontrolled infection, e.g. persistent bacteremia, supplemental oxygen or pressor supports, etc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial aims to compare the safety and effectiveness of using vemurafenib with obinutuzumab versus the standard treatment of cladribine with rituximab for cancer. The researchers

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
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I am 18 years old or older.
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My diagnosis of hairy cell leukemia has been confirmed through testing.
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I have not received any treatment for my condition.
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My blood counts are low enough to start standard treatment.
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I can take care of myself and am up and about more than half of the day.
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My liver and kidney functions are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am infected with HIV or HTLV-1.
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I do not have any ongoing serious infections.
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I cannot take medications by mouth due to a digestive condition.
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I have a heart condition called long QT syndrome or my blood tests show unbalanced minerals.
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I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.
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My leukemia does not show CD25.

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
Obinutuzumab
2014
Completed Phase 3
~3470
Vemurafenib
2015
Completed Phase 3
~3550

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,470 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,278 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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