SCCA Lymphoma Clinical Trials
|Closed||Indolent Non-Hodgkin Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone B-Cell Lymphoma
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.
- 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.
- 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.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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