Trial Search Results

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

The purpose of this study is to provide more information about whether giving rituximab and IDELA together can benefit patients with CLL who have a 17p deletion.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Idelalisib
  • Drug: Rituximab

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - Documented diagnosis of B-cell CLL, according to International Workshop on Chronic
   Lymphocytic Leukemia 2008

   - Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ
   hybridization (FISH) testing

   - 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

Key Exclusion Criteria:

   - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
   transformation)

   - Known presence of myelodysplastic syndrome

   - History of a non-CLL malignancy except for the following:

      - the malignancy has been in remission without treatment for ≥ 5 years prior to
      enrollment, or

      - carcinoma in situ of the cervix, or

      - adequately treated basal or squamous cell skin cancer or other localized
      non-melanoma skin cancer, or

      - asymptomatic prostate cancer without known metastatic disease and with no current
      requirement for therapy or requiring only hormonal therapy and with normal
      prostate specific antigen for ≥ 1 year prior to enrollment, or

      - ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or

      - other adequately treated Stage 1 or 2 cancer currently in complete remission

   - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
   enrollment

   - Ongoing liver injury

   - History of noninfectious pneumonitis

   - Ongoing inflammatory bowel disease

   - History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

   - Ongoing immunosuppressive therapy other than corticosteroids

   - Received last dose of study drug on another therapeutic clinical trial within 30 days
   prior to enrollment

   - Prior or ongoing clinically significant illness, medical condition, surgical history,
   physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting