A Phase 2 Study of CAL-101 in Indolent B-Cell Non-Hodgkin Lymphoma

• Conditions: Indolent B-Cell Non-Hodgkin Lymphoma; MedDRA version: 14.1Level: PTClassification code 10029601Term: Non-Hodgkin's lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022155-33-IT
• Lead Sponsor: CALISTOGA PHARMACEUTICALS, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients must meet all of the following conditions to be eligible for enrollment into the study: 1. Age =18 years. 2. Karnofsky performance score of =60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2). 3. Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of haematopoietic and lymphoid tissues: - Follicular lymphoma (FL) Grade 1, 2, or 3a - Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5 x 10^9/L - Lymphoplasmacytoid lymphoma (LPL) - Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal) 4. Histological materials documenting diagnosis of lymphoma available for review. 5. Measureable nodal disease, defined as the presence of =1 nodal lesion that measures =2 cm in a single dimension as assessed by CT or MRI 6. Prior treatment with = 2 prior chemotherapy- or immunotherapy-based regimens for iNHL. 7. Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL. 8. Lymphoma that is refractory to rituximab and to an alkylating agent. 9. Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL =3 weeks before initiation of study treatment (Visit 2). 10. All acute toxic effects (excluding alopecia, neurotoxicity, or anemia) of any prior antitumor therapy resolved to Grade =2 before initiation of study treatment (Visit 2). 11. Required baseline laboratory data (within 2 weeks prior to start of study drug administration). 12. For men and women of childbearing potential (ie, patients who are not postmenopausal or surgically sterile), willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods. 13. Willingness and ability to provide written informed consent and to comply with scheduled visits, drug administration plan, imaging studies and contrast dye administration, laboratory tests, other study procedures, and study restrictions. 14. Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation. 15. In the judgment of the investigator, participation in the protocol offers acceptable benefit:risk when considering current iNHL disease status, medical condition, and the potential benefits and risks of alternative treatments for iNHL.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

The presence of any of the following conditions will exclude a patient from study enrollment: 1. Central nervous system or leptomeningeal lymphoma. 2. Known histological transformation from iNHL to diffuse large B-cell lymphoma. 3. 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. 4. Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment (Visit 2). 5. Pregnancy or breastfeeding. 6. Ongoing alcohol or drug addiction. 7. 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. 8. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation. 9. Ongoing immunosuppressive therapy, including systemic corticosteroids. 10. Prior therapy with CAL-101 11. Exposure to another investigational drug within 3 weeks prior to start of study treatment. 12. Concurrent participation in another therapeutic treatment trial. 13. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified