Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma
Intervention: Idelalisib (Drug); Rituximab (Drug); Bendamustine (Drug); Ofatumumab (Drug); Fludarabine (Drug); Everolimus (Drug); Bortezomib (Drug); Chlorambucil (Drug); Lenalidomide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s): Thomas Jahn, MD, Study Director, Affiliation: Gilead Sciences
Summary
This study will evaluate the safety and clinical activity of idelalisib in combination with
an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, a
protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in
participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle
cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
Clinical Details
Official title: A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Extent of exposure to idelalisib and toxicity
Secondary outcome: Clinical Response RatePlasma concentrations of idelalisib Plasma concentrations of chemotherapeutic agents in a select subset of participants Plasma concentrations of everolimus Plasma concentration of lenalidomide
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥ 18
- Previously treated with relapsed or refractory disease (refractory defined as not
responding to a standard regimen or progressing within 6 months of the last course of
a standard regimen)
- Disease status requirement:
- For CLL patients, symptomatic disease that mandates treatment as defined by the
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) 2008 criteria
- For indolent NHL and MCL patients, measurable disease by CT scan defined as at
least 1 lesion that measures > 2 cm in a single dimension
- WHO performance status of ≤ 2
- For men and women of child-bearing potential, willing to use adequate contraception
(ie, latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration
of the study.
- For Cohort 7 only: Women of child bearing potential must have 2 negative
pregnancy tests prior to starting Lenalidomide.
- Able to provide written informed consent
Exclusion Criteria:
- Is not a good candidate to receive any of the drugs administered in the study for a
given disease (idelalisib, bendamustine, rituximab, ofatumumab, fludarabine,
everolimus, bortezomib, or chlorambucil), according to the clinical judgment of the
investigator
- Patients with atypical immunophenotype with t(11: 14) translocation or cyclin D1
over‑expression (CLL patients only)
- Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment
with an investigational product within 4-weeks prior to the baseline disease status
tests
- Had treatment with a short course of corticosteroids for symptom relief within 1‑week
prior to the baseline disease status tests
- Has had an allogeneic hematopoietic stem cell transplant
- Has known active central nervous system involvement of the malignancy
- Is pregnant or nursing
- Has active, serious infection requiring systemic therapy. Patients may receive
prophylactic antibiotics and antiviral therapy at the discretion of the investigator
- Has absolute neutrophil count (ANC) < 1000/µL, unless it is related to underlying
CLL, MCL or indolent NHL, the latter documented by > 50% infiltration of bone marrow
by tumor cells
- Has platelet count < 75000/µL, unless it is related to underlying CLL, MCL, or iNHL,
the latter documented by > 50% infiltration of bone marrow by tumor cells
- Has serum creatinine ≥ 2. 0 mg/dL
- For Cohort 7 only: Has creatinine clearance < 60 mL/min
- Has serum bilirubin ≥ 2 mg/dL (unless due to Gilbert's syndrome) for patients with
iNHL or CLL; for patients with MCL, serum bilirubin ≥ 1. 5 x upper limit of normal
- Has serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥ 2 x upper
limit of normal
- Has Child-Pugh Class B or C hepatic impairment
- Has a positive test for HIV antibodies
- Has active hepatitis B or C (confirmed by RNA test). Patients with serologic evidence
of prior exposure are eligible.
- Prior treatment with idelalisib
Locations and Contacts
Clearview Cancer Institute, Huntsville, Alabama 35805, United States
UCLA, Los Angeles, California 90024, United States
Stanford Cancer Center, Palo Alto, California 94304-5548, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Long Island Jewish Medical Center, New Hyde Park, New York 11040, United States
Weill Medical College of Cornell, New York, New York 10021, United States
Willamette Valley Cancer Institute and Research Center, Springfield, Oregon 97477, United States
Sarah Cannon Research Institute, Nashville, Tennessee 37203, United States
MD Anderson Cancer, Houston, Texas 77030, United States
North Star Lodge Cancer Center, Yakima, Washington 98902, United States
Additional Information
Starting date: April 2010
Last updated: May 11, 2015
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