Gene Therapy Clinical Trials

Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma

The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: PCI-32765

Eligibility


Inclusion Criteria:

   - Women and men ≥ 18 years of age. There is no experience with this drug in a pediatric
   population.

   - Body weight ≥ 40 kg.

   - Recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL)
   according to WHO classification, including small lymphocytic lymphoma/ chronic
   lymphocytic leukemia (SLL/CLL) lymphoplasmacytic lymphoma, including Waldenström's
   Macroglobulinemia (WM), and pre-identified DLBCL ABC subtype oFor the DLBCL-ABC
   cohort, documented, activated B-cell subtype by either immunohistochemistry or tissue
   microarray analysis.

   - Measurable disease (for NHL, bidimensional disease ≥ 2 cm diameter in at least one
   dimension, for CLL ≥ 5000 leukemia cells/mm3, for WM presence of immunoglobulin M
   paraprotein with a minimum IgM level ≥ 1000 mg/dL and infiltration of bone marrow by
   lymphoplasmacytic cells), and pre-identified DLBCL ABC subtype by immunohistochemistry
   (IHC).

   - Have failed ≥ 1 previous treatment for lymphoma and no standard therapy is available.
   Patients with diffuse large B cell lymphoma must have failed, refused or be ineligible
   for autologous stem cell transplant.

   - ECOG performance status of ≤ 1.

   - Ability to swallow oral capsules without difficulty.

   - Willing and able to sign a written informed consent.

Exclusion Criteria:

   - More than four prior systemic therapies (not counting maintenance rituximab), except
   for CLL patients. Salvage therapy/conditioning regimen leading up to autologous bone
   marrow transplantation is considered to be one regimen (This inclusion criterion does
   not apply to the DLBCL-ABC cohort).

   - Prior allogeneic bone marrow transplant.

   - Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks
   before first day of study drug dosing.

   - Major surgery within 4 weeks before first day of study drug dosing.

   - CNS involvement by lymphoma.

   - Active opportunistic infection or treatment for opportunistic infection within 4 weeks
   before first day of study drug dosing.

   - History of malabsorption.

   - Laboratory abnormalities:

      - Creatinine > 1.5 × institutional upper limit of normal (ULN)

      - Total bilirubin > 1.5 x institutional ULN (unless elevated from documented
      Gilbert's syndrome)

      - AST or ALT > 2.5 × institutional ULN

      - Platelet count < 75,000/µL (unless patients have CLL and bone-marrow involvement,
      provided they are not transfusion-dependent)

      - Absolute neutrophil count (ANC) < 1500/µL (unless patients have CLL and
      bone-marrow involvement)

      - Hgb < 8.0 g/dL

   - Uncontrolled illness including but not limited to: ongoing or active infection,
   symptomatic congestive heart failure (New York Heart Association Class III or IV heart
   failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that
   would limit compliance with study requirements.

   - Risk factors for, or use of medications known to prolong QTc interval or that may be
   associated with Torsades de Pointes within 7 days of treatment start.

   - QTc prolongation (defined as a QTc > 450 msecs) or other significant ECG abnormalities
   including 2nd degree AV block type II, 3rd degree AV block, or bradycardia
   (ventricular rate less than 50 beats/min). If the screening ECG has a QTc > 450 msecs,
   the ECG can be submitted for a centralized, cardiologic evaluation.

   - History of myocardial infarction, acute coronary syndromes (including unstable
   angina), coronary angioplasty and/or stenting within the past 6 months.

   - Known HIV infection.

   - Hepatitis B sAg or Hepatitis C positive.

   - Other medical or psychiatric illness or organ dysfunction which, in the opinion of the
   investigator, would either compromise the patient's safety or interfere with the
   evaluation of the safety of the study agent.

   - Pregnant or lactating women (female patients of child-bearing potential must have a
   negative serum pregnancy test within 14 days of first day of drug dosing, or, if
   positive, a pregnancy ruled out by ultrasound).

   - Women of child-bearing potential or sexually active men, unwilling to use adequate
   contraceptive protection during the course of the study.

   - History of prior cancer < 2 years ago, except for basal cell or squamous cell
   carcinoma of the skin, cervical cancer in situ or other in situ carcinomas.

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
Cancer Clinical Trials Office
650-498-7061
Not Recruiting