A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06561360
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hairy Cell Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vemurafenib — DRUG
    Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.
  • Obinutuzumab — DRUG
    Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.
  • Cladribine — DRUG
    Cladribine IV on days 1-5 concurrently with rituximab.
  • Rituximab — DRUG
    Rituximab on days 1-5 concurrently with rituximab.

Study Details

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.

Key Dates

Start date
Sep 9, 2024
Status verified
May 2026
Primary completion
Sep 9, 2027
Completion
Sep 9, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

incidences of ≥ grade 3 treatment-related toxicities [ Time Frame: within 6 months of treatment ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115
Eric Winer, MD
617-632-6876
Mayo Clinic Cancer CenterRochesterMinnesota55905
Sameer Parikh, M.B.B.S.
507-218-0772
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)CommackNew York11725
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Jae Park, MD
646-608-3743
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Jae Park, MD
646-608-3743
Ohio State UniversityColumbusOhio43210
Michael Grever, MD
614-293-3196
Michael Grever, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMayo Clinic Cancer Center· Rochester, MNMemorial Sloan Kettering at Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)· Commack, NY

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