A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be ≥ 18 years of age

• Histologically confirmed classical HCL by the enrolling institution

• Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.

• Has not received any prior therapy for the disease

• Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K

• ECOG performance status of 0 - 2

• Acceptable pre-study organ function during screening as defined as:

‣ Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);

⁃ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN; and

⁃ Serum creatinine ≤ 1.5x ULN

• Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \< 480 msec

• For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib and cladribine, and 18 months after discontinuation of rituximab and obinutuzumab

• For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib

• Negative serum pregnancy test within 7 days of commencement of treatment in women of childbearing potential

Locations
United States
Massachusetts
Dana Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Minnesota
Mayo Clinic Cancer Center
NOT_YET_RECRUITING
Rochester
New Jersey
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Ohio
Ohio State University
NOT_YET_RECRUITING
Columbus
Contact Information
Primary
Jae Park, MD
parkj6@mskcc.org
646-608-3743
Backup
Mark Geyer, MD
646-608-3745
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2027-09-09
Participants
Target number of participants: 86
Treatments
Experimental: Vemurafenib plus Obinutuzumab
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.
Active_comparator: Standard treatment of Cladribine plus Rituximab
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.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov