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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01088048
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
Clinical Associate Professor, Medicine - Hematology
Clinical Associate Professor, Medicine - Oncology
Clinical Associate Professor, Medicine - Hematology
Professor of Medicine (Hematology)
Key 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
Key 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
drug: Fludarabine
drug: Everolimus
drug: Bortezomib
drug: Rituximab
drug: Bendamustine
drug: Ofatumumab
drug: Chlorambucil
drug: Idelalisib
drug: Lenalidomide
Not Recruiting
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School of Medicine
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Stanford,
CA
94305
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650-498-7061