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COMPLETEDPHASE1

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

Phase I Dose-Escalation Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma

NCT00849654•Pharmacyclics LLC.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+14 more criteria

Locations (9)

Stanford University School of Medicine

Palo Alto, California, United States

University of Chicago

Chicago, Illinois, United States

National Cancer Institute

Bethesda, Maryland, United States

New York Prebyterian Hospital Cornell Medical Center

New York, New York, United States

Willamette Valley Cancer Institute/Research Ctr

Eugene, Oregon, United States

University of Texas, MD Anderson

Houston, Texas, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

Northwest Cancer Specialists, Vancouver Cancer Center

Vancouver, Washington, United States

Yakima Valley Memorial Hospital/North Star Lodge Cancer Ctr

Yakima, Washington, United States

Key Dates

Start Date

February 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

May 22, 2013

Enrollment

ACTUAL participants

Conditions

B-Cell LymphomaB-Cell Leukemia

Interventions

PCI-32765

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma