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Monoclonal Antibodies

Vemurafenib + Obinutuzumab for Hairy Cell Leukemia

Q: Can you explain how Obinutuzumab is often employed?

<p>Obinutuzumab can be used to fight lymphoid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, erdheim-chester disease, and metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Obinutuzumab

2015

Completed Phase 3

~3250

Vemurafenib

2015

Completed Phase 3

~3100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,590 Total Patients Enrolled

116 Trials studying Leukemia

9,312 Patients Enrolled for Leukemia

Dana-Farber Cancer InstituteOTHER

1,078 Previous Clinical Trials

340,842 Total Patients Enrolled

77 Trials studying Leukemia

10,390 Patients Enrolled for Leukemia

Yale UniversityOTHER

1,847 Previous Clinical Trials

2,736,498 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other research projects that have studied Obinutuzumab?

"Currently, there are 151 clinical trials underway to study Obinutuzumab. Phase 3 Trials, which are the most advanced type of trial, make up 21 of these investigations. Although many of these studies take place in Tampa, Florida; There are 6501 total locations for these Obinutuzumab clinical trials."

Answered by AI

Can you explain how Obinutuzumab is often employed?

"Obinutuzumab can be used to fight lymphoid leukemia, erdheim-chester disease, and metastatic melanoma."

Answered by AI

How many individuals are included in this experiment?

"Right now, this trial is not open to new participants. It was initially posted on February 9th, 2018 and updated most recently on February 7th, 20212. However, if you are looking for other studies, there are currently 1466 trials actively searching for patients with leukemia and 151 trials for Obinutuzumab that are admitting patients."

Answered by AI

Are patients still being enrolled in this trial?

"This specific trial has completed its recruitment drive. The listing was first posted on February 9th, 2018 and last updated on February 7th, 2022. There are 1466 other trials for leukemia and 151 for Obinutuzumab currently looking for patients if you're interested in participating in clinical research."

Answered by AI

What are the risks associated with treatment using Obinutuzumab?

"Obinutuzumab is a medication that our team has given a safety rating of 2. This is because, although there is some evidence supporting its safety profile, there are no Phase 2 trials indicating its efficacy."

Answered by AI

From how many different sites is this research being coordinated?

"This trial is currently being conducted at 8 different hospitals, with Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, Dana Farber Cancer Institute in Boston, and Memoral Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown among them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03410875.

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