Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT02824029 | Completed Phase 2 Results DMC

• 3 other identifiers: 2016-033NCI-2016-00879P30CA022453
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

This phase II trial evaluates how effective 560 mg of ibrutinib taken by mouth daily is in the treatment of classical Hodgkin lymphoma which recurs or does not respond to initial treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, by altering the environment around the tumor or by affecting the immune system.

Conditions

Classical Hodgkin Lymphoma; Recurrent Hodgkin Lymphoma; Refractory Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate (ORR) defined as the proportion of participants having a complete (CR) and partial (PR) response. A one-sample binomial test will be used to assess ORR.

  From date of study entry to date of progression or death up to 24 months

Secondary Outcomes (2)

• Duration of Response (DOR)

  From date of documented tumor response, CR or PR, to date of disease progression or death, up to 24 months

• Progression Free Survival (PFS)

  From date of study entry to date of progression or death up to 24 months.

Study Arms (1)

Treatment (ibrutinib)

EXPERIMENTAL

Patients receive ibrutinib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, PCI-32765

Treatment (ibrutinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ibrutinib)

Pharmacological Study OTHER

Correlative studies

Treatment (ibrutinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory classical HL who have previously received autologous stem cell transplant and/or allogeneic stem cell transplant. Patients must have received prior autologous stem cell transplant at least 12 weeks (3 months) before the first dose of ibrutinib and/or allogeneic stem cell transplant must have been completed at least 6 months prior to the first dose of Ibrutinib. OR
• Patients with relapsed or refractory HL who have failed at least 2 lines of prior therapy and are not eligible for autologous stem cell transplant due to:
• Inability to achieve a CR or PR prior to transplant
• Age or comorbid conditions
• Inability to collect stem cells
• Completion of any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of ibrutinib. Patients must have completed any prior immunotherapy (e.g., rituximab or PD-1 inhibition) or antibody drug conjugate therapy (e.g. brentuximab vedotin) at least 4 weeks prior to the first dose of ibrutinib in the absence of clear disease progression.
• Prior treatment with at least 2 lines of therapy for HL including brentuximab vedotin. In those patients who cannot receive brentuximab vedotin, treatment with 2 prior therapeutic regimens is sufficient.
• Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm in minimum dimension by CT scan with contrast, as assessed by the site radiologist.
• Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization, with the exception of PEGylated GCSF (pegfilgrastim) and darbopoeitin which require at least 14 days prior to screening and randomization defined as:
• Absolute neutrophil count \>750 cells/mm3 (0.75 x 109/L).
• Platelet count \>50,000 cells/mm3 (50 x 109/L).
• Hemoglobin \>8.0 g/dL.
• Adequate hepatic and renal function defined as:
• Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN).
• Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault)

You may not qualify if:

• Prior allogeneic Stem cell transplant within 6 months.
• Active GVHD or concurrent treatment with immunosuppressive medications as prophylaxis for GVHD
• Previous therapy with BTK inhibition
• Known cerebral/meningeal disease
• Nodular lymphocyte predominant Hodgkin's Lymphoma subtype
• Concurrent therapy with other systemic anti-neoplastic or investigational agents
• Patients with a known hypersensitivity to any excipient contained in the drug formulation
• History of other malignancies, except:
• Malignancy treated with curative intent and with no known active disease present for
• ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated carcinoma in situ without evidence of disease.
• Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration \[\>14 days\] of \>20 mg/day of prednisone) within 28 days of the first dose of study drug.
• Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
• Recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Muqbil I, Chaker M, Aboukameel A, Mohammad RM, Azmi AS, Ramchandren R. Pre-clinical anti-tumor activity of Bruton's Tyrosine Kinase inhibitor in Hodgkin's Lymphoma cellular and subcutaneous tumor model. Heliyon. 2019 Aug 31;5(8):e02290. doi: 10.1016/j.heliyon.2019.e02290. eCollection 2019 Aug.

  PMID: 31508518 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Dipenkumar Modi, MD
• Organization: Karmanos Cancer Institute

modid@karmanos.org

313-576-8782

Study Officials

• Dipenkumar Modi, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: May 12, 2023
• Study Completion: January 8, 2025
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Locations

US (4)