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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
Status Conditions Phase Study ID
Closed Hodgkin Lymphoma Phase II NCT01393106
Summary

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.


Investigator
Ajay Gopal, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
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 Updated
September 14, 2012
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.