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A 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

Phase 2
18 Years
Open (Enrolling)
Indolent Non-Hodgkin Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytoid Lymphoma, Marginal Zone Lymphoma

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Trial Information

A 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

This is a Phase 2, open-label, single-arm, 2-stage, efficacy, safety, and pharmacodynamic
study of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL)
that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.

Eligible patients will initiate oral therapy with CAL-101 at a starting dose of 150 mg taken
twice per day. Treatment with CAL-101 can continue in compliant patients as long as the
study is still ongoing and the patients appear to be benefiting from treatment with
acceptable safety.

Inclusion Criteria:

- Age ≥18 years.

- Karnofsky performance score of ≥60 (Eastern Cooperative Oncology Group [ECOG]
performance score of 0, 1, or 2).

- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following:

- Follicular lymphoma (FL)

- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count

- Lymphoplasmacytoid lymphoma (LPL)

- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)

- Prior treatment with ≥2 prior chemotherapy- or immunotherapy-based regimens for iNHL.

- Prior treatment with rituximab and with an alkylating agent (eg, bendamustine,
cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for

- Lymphoma that is refractory to rituximab and to an alkylating agent.

- For men and women of childbearing potential, willingness to abstain from sexual
intercourse or employ an effective method of contraception during the study drug
administration and follow-up periods.

- Willingness and ability to provide written informed consent and to comply with the
protocol requirements.

Exclusion Criteria:

- Central nervous system or leptomeningeal lymphoma.

- Known histological transformation from iNHL to diffuse large B-cell lymphoma.

- History of a non-lymphoma malignancy except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localized prostate cancer, other adequately treated Stage
1 or 2 cancer currently in complete remission, or any other cancer that has been in
complete remission for ≥5 years.

- Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
upper respiratory tract infections) at the time of initiation of study treatment.

- Pregnancy or breastfeeding.

- Ongoing alcohol or drug addiction.

- Known history of drug-induced liver injury, chronic active HCV, chronic active HBV,
alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis,
ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal

- History of prior allogeneic bone marrow progenitor cell or solid organ

- Ongoing immunosuppressive therapy, including systemic corticosteroids. Patients may
be using topical or inhaled corticosteroids.

- Prior therapy with CAL 101

- Exposure to another investigational drug within 3 weeks prior to start of study

- Concurrent participation in another therapeutic treatment trial.

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the patient; alter the absorption, distribution,
metabolism or excretion of the study drug; or impair the assessment of study results.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate during treatment with CAL-101 based on standard criteria

Outcome Time Frame:

every 8-12 weeks

Safety Issue:


Principal Investigator

Langdon Miller, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

December 2018

Related Keywords:

  • Indolent Non-Hodgkin Lymphoma
  • Follicular Lymphoma
  • Small Lymphocytic Lymphoma
  • Lymphoplasmacytoid Lymphoma
  • Marginal Zone Lymphoma
  • indolent Non-Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma
  • iNHL
  • NHL
  • CAL-101
  • PI3K
  • Phosphatidylinositol 3-kinase
  • Follicular Lymphoma (FL)
  • Small lymphocytic lymphoma (SLL)
  • Lymphoplasmacytoid lymphoma (LPL)
  • Marginal zone lymphoma (MZL)
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone



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