Clinical Trials

Text Size A A

E-Mail to a Friend






secret  Click to Play Audio


Chronic Lymphoid Leukemia (CLL)

Idelalisib + Bendamustine and Rituximab for Untreated CLL (9064)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
Status Conditions Phase Study ID
Recruiting Chronic Lymphocytic Leukemia Phase III 9064
NCT01980888
Summary

This study will evaluate the effect of the addition of idelalisib to bendamustine and rituximab on minimal residual disease (MRD) and evaluate the progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).


Investigator
John M. Pagel, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
  • No prior therapy for CLL other than corticosteroids for disease complications
  • CLL that warrants treatment
  • Presence of measurable lymphadenopathy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Exclusions (conditions that would prevent participation in this study)
  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
  • Ongoing liver injury
  • Ongoing drug-induced pneumonitis
  • Ongoing inflammatory bowel disease
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy other than corticosteroids
  • Concurrent participation in another therapeutic clinical trial
Last Updated
June 03, 2014
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.