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



Status:Completed
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:April 2010
End Date:April 2015

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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

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).


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
We found this trial at
11
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Houston, Texas 77030
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Huntsville, Alabama 35805
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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New York, New York 10021
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Palo Alto, California 94304
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Springfield, OR
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Yakima, Washington 98902
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Yakima, WA
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