Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00849654
Other study ID # PCYC-04753
Secondary ID
Status Completed
Phase Phase 1
First received February 20, 2009
Last updated May 21, 2013
Start date February 2009
Est. completion date July 2012

Study information

Verified date May 2013
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT01177878

Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PCI-32765
In the dose-escalation cohorts, PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5, and 17.5 mg/kg/d dose orally once per day for 28 days followed by a 7-day rest period to determine the MTD. If MTD is not reached, dosing levels may be increased beyond 17.5mg/kg/d by 33% increments. In the continuous dosing cohorts, PCI-32765 will be administered in 8.3 mg/kg/day and 560 mg/day (fixed dose) dose orally once per day for 35 days.

Locations

Country Name City State
United States National Cancer Institute Bethesda Maryland
United States University of Vermont College of Medicine Burlington Vermont
United States University of Chicago Chicago Illinois
United States Willamette Valley Cancer Institute/Research Ctr Eugene Oregon
United States University of Texas, MD Anderson Houston Texas
United States New York Prebyterian Hospital Cornell Medical Center New York New York
United States Stanford University School of Medicine Palo Alto California
United States Northwest Cancer Specialists, Vancouver Cancer Center Vancouver Washington
United States Yakima Valley Memorial Hospital/North Star Lodge Cancer Ctr Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity assessment for each patient. At the end of the first 35 day cycle Yes
Primary Adverse events 30 days after last dose of study drug Yes
Primary Pharmacokinetic/ Pharmacodynamic assessments during Cycle 1 No
Secondary Tumor response at the end of Cycles 2, 4, and 6 unitl progression No
See also
  Status Clinical Trial Phase
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Withdrawn NCT05929716 - An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Recruiting NCT05016947 - Venetoclax Plus Inotuzumab for B-ALL Phase 1
Completed NCT02900716 - Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas Phase 1
Completed NCT03068416 - CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy Phase 2
Not yet recruiting NCT05014100 - Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma Phase 2
Recruiting NCT05934838 - A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas Phase 1
Terminated NCT04023071 - FT516 in Subjects With Advanced Hematologic Malignancies Phase 1
Active, not recruiting NCT04148430 - A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy Phase 2
Completed NCT02933320 - BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia Phase 1/Phase 2
Active, not recruiting NCT03133221 - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Phase 2
Completed NCT02741388 - A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP Phase 1
Completed NCT02300402 - Detection and Characterization of Residual Masses in Lymphomas
Terminated NCT02266147 - Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma Phase 1/Phase 2
Terminated NCT00906841 - Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma Phase 2
Completed NCT00338494 - Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma Phase 1
Recruiting NCT05487651 - Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies Phase 1
Withdrawn NCT05570188 - Anti-CD19 Universal CAR-NK Cells Therapy Combined With HSCT for B Cell Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT03281551 - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma Phase 1

External Links