Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents

Study Status

Open to Enrollment

Study Description

This is a clinical trial for people with the following types of B-cell indolent non-Hodgkin lymphoma (iNHL):

  • follicular lymphoma
  • small lymphocytic lymphoma
  • lymphoplasmacytoid lymphoma
  • marginal zone lymphoma

Study participants must have received at least 2 different prior treatments for iNHL, and at some point during prior therapy they must have received rituximab and a type of chemotherapy called an alkylating agent.

The purpose of this study is to determine whether the investigational drug CAL-101 is safe and effective for treating people with iNHL once their iNHL has become too difficult to control with available therapies.

All cells in the body receive signals to grow and survive, but sometimes these signals can get out of control, causing too much cell growth. When cell growth gets out of control, cancers like iNHL can develop. CAL-101 blocks some of the cell functions that cause iNHL to grow and survive. By blocking these functions, CAL-101 may reduce or prevent iNHL from growing and surviving. Results from earlier studies suggest that CAL-101 may help control iNHL.

CAL-101 is a tablet. Study participants will take CAL-101 twice per day. Participants will be seen for study visits:

  • every 2 weeks for the first 12 weeks of study treatment
  • every 4 weeks until Week 24
  • every 6 weeks until Week 48
  • every 12 weeks until the end of the study

Disease Status and/or Stage

Refractory Indolent B-cell non-Hodgkin Lymphoma

Sponsor

Calistoga

Key Eligibility

  • Diagnosis of B-cell iNHL with one of the following subtypes:
    • Follicular lymphoma
    • Small lymphocytic lymphoma
    • Lymphoplasmacytoid lymphoma
    • Marginal zone lymphoma
  • Prior treatment with ≥ 2 chemotherapy or immunotherapy based regimens for iNHL
  • Prior treatment with rituximab and with an alkylating agent
  • Lymphoma that is refractory to rituximab and to an alkylating agent
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Peter Martin, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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