SCCA Lymphoma Clinical Trials
CAL-101 for Relapsed or Refractory Hodgkin Lymphoma
A Phase 2 Study to Assess the Efficacy and Safety of CAL 101 in Patients With Relapsed or Refractory Hodgkin Lymphoma
|Closed||Hodgkin Lymphoma||Phase II||NCT01393106|
The purpose of this study is to evaluate the efficacy and safety of CAL-101 (GS-1101) in patients with relapsed of refractory Hodgkin Lymphoma(HL). The primary objective will be to assess the overall response rate.
Eligibility Criteria (must meet the following to participate in this study)
- Age ≥12 years.
- Karnofsky performance score of ≥60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2).
- Histologically confirmed diagnosis of classic HL (ie, nodular sclerosis, mixed cellularity, lymphocyte depleted, and or lymphocyte rich types).
- Nodal HL that is outside of all prior radiation therapy fields that shows fluorodeoxyglucose [FDG] avidity (defined as focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology), and is measurable (defined as the presence of ≥1 nodal lesion that measures ≥2 cm in a single dimension as assessed by CT, PET/CT, or magnetic resonance imaging [MRI]).
- Relapsed or refractory HL after prior myeloablative therapy with ASCT or after ≥2 prior chemotherapy-containing regimens and no curative option with conventional therapy.
- Discontinuation of all radiotherapy or chemotherapy for the treatment of HL great than or equal to 3 weeks before initiation of study treatment and discontinuation of all radioimmunotherapy for HL (Visit 2).
- 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).
- 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 protocol requirements.
Exclusions (conditions that would prevent participation in this study)
- Known active central nervous system or leptomeningeal 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 (Visit 2).
- 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.
- Prior therapy with CAL-101 (GS-1101).
- 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 UpdatedSeptember 14, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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