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

ConditionHairy Cell Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.

Known hypersensitivity to any of the study drugs.

Patients with known long QT syndrome or uncorrectable electrolyte abnormalities

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Vemurafenib plus ObinutuzumabExperimental treatment 2 interventions
Group B: Standard treatment of Cladribine plus RituximabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

incidences of ≥ grade 3 treatment-related toxicities

per CTCAE v5.0 within first 6 months from the start of the treatment to account delayed toxicities of the treatments

Time frame
within 6 months of treatment

Secondary outcomes

1

complete remission

Response will be determined by the Consensus Resolution response criteria. Complete response (CR) * A morphological absence of hairy cells in the blood and bone marrow * A normalization of any organomegaly and cytopenias

Time frame
2 years
2

partial response

Partial response (PR) °A normalization of cytopenias °≥50% reduction in organomegaly and bone marrow hairy cells.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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