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Monoclonal Antibodies

Vemurafenib + 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

Histologically confirmed classical HCL by the enrolling institution

ECOG performance status of 0-2

Must not have

Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)

Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Summary

This trial is testing a combination of two drugs, vemurafenib and obinutuzumab, to treat hairy cell leukemia (HCL) that has not been treated before. The trial will have 28 patients total, and will test the efficacy of the combination treatment. If the treatment is successful, bone marrow aspirate and biopsy will be performed to assess response and evaluate minimal residual disease (MRD).

Who is the study for?

Adults with previously untreated classical Hairy Cell Leukemia who meet specific blood count criteria and are in good physical condition. They must have normal organ function, agree to use contraception, and not be pregnant. Excluded are those with hepatitis B or C, HIV, other cancers needing treatment that could interact with the trial drugs, uncontrolled infections, or a history of liver disease.

What is being tested?

The trial is testing an oral drug called Vemurafenib combined with Obinutuzumab infusions against Hairy Cell Leukemia. Initially, 9 patients will receive this combination to see if it's effective; if successful, another 19 will join. The treatment spans over four cycles (16 weeks), followed by bone marrow tests for response evaluation.

What are the potential side effects?

Possible side effects include skin rash or lesions due to Vemurafenib and infusion-related reactions from Obinutuzumab such as fever or chills. Liver enzymes might increase indicating potential liver issues; heart rhythm problems could also occur.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis of hairy cell leukemia has been confirmed through testing.

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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I have not received any treatment for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with HIV or HTLV-1.

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I have been tested for hepatitis C; my PCR test is negative.

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I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.

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I do not have any active and uncontrolled infections.

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I cannot take medications by mouth due to a digestive condition.

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My leukemia does not show CD25.

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I am on treatment that might not mix well with vemurafenib or obinutuzumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of vemurafenib in combination with obinutuzumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Untreated Hairy Cell LeukemiaExperimental Treatment2 Interventions

Participants with HCL with no prior treatment for the disease

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3550

Obinutuzumab

2014

Completed Phase 3

~3470

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,956 Previous Clinical Trials

595,526 Total Patients Enrolled

117 Trials studying Leukemia

9,410 Patients Enrolled for Leukemia

Dana-Farber Cancer InstituteOTHER

1,100 Previous Clinical Trials

353,067 Total Patients Enrolled

79 Trials studying Leukemia

20,125 Patients Enrolled for Leukemia

Yale UniversityOTHER

1,907 Previous Clinical Trials

3,019,019 Total Patients Enrolled

5 Trials studying Leukemia

48 Patients Enrolled for Leukemia

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03410875 — Phase 2

Leukemia Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT03410875 — Phase 2

Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410875 — Phase 2

Leukemia Research Study Groups: Untreated Hairy Cell Leukemia

~1 spots leftby Jan 2025

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