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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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University of Wisconsin Madison,, Wisconsin  53792-5666
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University of Virginia Medical Center Charlottesville, Virginia  22908
Sarah Cannon Research Institute Nashville, Tennessee  37203
Central Coast Medical Oncology Santa Maria, California  93454
Northwestern University Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611-2941
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Central Hematology Oncology Medical Group Alhambra, California  91801
St. Mary's Hospital Regional Cancer Center Grand Junction, Colorado  81502
The Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210
Collaborative Research Group, LLC Boynton Beach, Florida  33435
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John Theurer Cancer Center Hackensack University Medical Center Hackensack, New Jersey  07601
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