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SCCA Lymphoma Clinical Trials

CAL-101 for Indolent B-Cell Non-Hodgkin Lymphoma (UW 10055)
A Phase II 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
Status Conditions Phase Study ID
Closed Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytoid Lymphoma
Marginal Zone B-Cell Lymphoma
Phase II UW 10055
NCT01282424
Summary

The purpose of this study is to evaluate the efficacy and safety 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. The primary objective will be to assess the overall response rate.


Investigator
Ajay Gopal, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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 iNHL.
  • 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.

 

Exclusions (conditions that would prevent participation in this study)
  • 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 hypertension.
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
  • 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 treatment.
  • 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.
Last Updated
June 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.