DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Rate

Plasma 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017