Phase 2
N=39
Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Recurrent Hodgkin Lymphoma · Refractory Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02744612 ↗Enrolled (actual)
39
Serious AEs
25.6%
Results posted
Jul 2023
Primary outcome: Primary: Complete Response (CR) Rate — 0; 36 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brentuximab Vedotin (Drug); Ibrutinib (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
0; 36 | — |
| SECONDARY Overall Response Rate (ORR) |
33; 67 | — |
Summary
This phase II trial studies how well ibrutinib and brentuximab vedotin work in treating patients with Hodgkin lymphoma that has returned (relapsed) or does not respond to treatment (refractory). Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as brentuximab vedotin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ibrutinib together with brentuximab vedotin may be a better treatment for Hodgkin lymphoma.
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically documented or cytologically confirmed Hodgkin lymphoma with CD30 expression
- Patients must have absolute neutrophil count (ANC) >= 1000/uL; neupogen can be given before and during treatment to achieve target ANC >= 1000/uL
- Patients must have platelets (plt) >= 50,000/uL; platelet transfusion and packed red blood cell transfusion can also be given prior to the start of treatment and during treatment to achieve a target plt >= 50,000/uL provided that patients have not received growth factors for at least 14 days prior to entering trial
- Patients must have hemoglobin >= 8.5 g/dl; platelet transfusion and packed red blood cell transfusion can also be given prior to the start of treatment and during treatment to achieve a target hemoglobin of >= 8.5/ul provided that patients have not received growth factors for at least 14 days prior to entering trial
- Patients must have measurable disease > 1.5 cm evidenced by computed tomography (CT) scan of the neck/chest/abdomen (abd)/pelvis or CT/positron emission tomography (PET) scans
- Patients must be either refractory to or relapsed after 1 line of therapy
- Prior radiation therapy is allowed
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Female subject is either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
- Male subject agrees to use an acceptable method of contraception for the duration of the study
- Over 40 kg; life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) of 0-2
- Total bilirubin within 1.5 x the upper limit of normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = = 30 ml/min (Cockcroft-Gault) and/or 24 urine analysis as needed
- Prothrombin time (PT)/international normalized ratio (INR) = 470 msec; subjects with a cardiac pacemaker who have a QTc interval of >= 470 msec may be eligible if these findings are considered not clinically significant as documented via a cardiology evaluation
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Patients with active central nervous system (CNS) disease or history of brain metastases are excluded from study
- Patients may be on steroids prior to initiation of treatment, provided that, by cycle 1 day 1, steroids use was tapered down to less than or equal to 20 mg of prednisone
- Pregnant women are excluded from this study because of the potential teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued
- Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
- Recent infection requiring systemic treatment that was completed = = 200 and are on highly active antiretroviral therapy (HAART) medication are allowed
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification
- STUDY-SPECIFIC EXCLUSIONS:
- Patient has hypersensitivity to brentuximab vedotin
- Refractory to prior brentuximab vedotin (defined as developing progressive disease while on treatment or progressed within 3 month of finished last dose of brentuximab vedotin)
- No active graft-versus-host disease (GVHD) or on immunos
Data sourced from ClinicalTrials.gov (NCT02744612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.