Clinical Trials Logo
  1. Home
  2. Waldenstrom Macroglobulinemia
  3. NCT05172700
  4. Details
NCT05172700 Clinical Trial

Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Waldenstrom Macroglobulinemia Clinical Trial

Official title:
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05172700
Other study ID # 17712
Secondary ID J2N-OX-Y001
Status Available
Phase
First received
Last updated

Study information
Verified date October 15, 2023
Source Eli Lilly and Company
Contact In the U.S., physicians seeking help on behalf of their patients
Phone 1-800-LillyRx (1-800-545-5979)
Email Clinicaltrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have been diagnosed with: - CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor - MCL that has been previously treated with a covalent BTK inhibitor - Richter's Transformation (RT) with previous Richter's directed-therapy - Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor - Are not eligible for an ongoing pirtobrutinib clinical trial Exclusion Criteria: - Inadequate organ function - Significant cardiovascular disease - History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days - Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection - Active, uncontrolled autoimmune cytopenia - Clinically significant active malabsorption syndrome - Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pirtobrutinib
Administered orally.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Loxo Oncology, Inc.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Completed NCT03630042 - Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Recruiting NCT05952037 - Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia Phase 2
Completed NCT04062448 - A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM) Phase 2
Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Recruiting NCT03679455 - A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1 Phase 2
Not yet recruiting NCT05099471 - Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia Phase 2
Not yet recruiting NCT04830046 - Covid-19 Vaccine Responsiveness in MM and Waldenstrom
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT01093586 - Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies Phase 2
Active, not recruiting NCT03620903 - Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia Phase 2
Not yet recruiting NCT04702932 - Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies
Active, not recruiting NCT03133221 - 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation Phase 2
Completed NCT00608361 - Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery Phase 1
Completed NCT00777738 - Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia Phase 2
Completed NCT00438880 - Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Active, not recruiting NCT00075478 - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 3
Completed NCT01272817 - Nonmyeloablative Allogeneic Transplant N/A