EUCTR2015-001671-51-ESActive, not recruitingPhase 1
A RANDOMIZED, OPEN LABEL, PHASE 2 STUDY OF RITUXIMAB AND BENDAMUSTINE WITH OR WITHOUT BRENTUXIMAB VEDOTIN FOR RELAPSED OR REFRACTORY CD30-POSITIVE DIFFUSE LARGE B CELL LYMPHOMA
Seattle Genetics, Inc.0 sites110 target enrollmentStarted: February 17, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patients with histologically confirmed CD30-positive DLBCL or follicular non-Hodgkin lymphoma (NHL) grade 3b, defined as any detectable CD30 expression on tumor cells based on local pathologic assessment.
- •2. Patients must have relapsed or refractory disease following:
- •a. second-line or greater salvage systemic therapy, or
- •b. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
- •3. Age 18 and older.
- •4. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist.
- •5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- •6. The following baseline laboratory data:
- •a. Absolute neutrophil count (ANC) > or =1000/µL (unless documented bone marrow involvement)
- •b. Platelet count > or =75,000/µL (unless documented bone marrow involvement)
- •c. Serum bilirubin < or =1.5 × upper limit of normal (ULN) or < or =3 × ULN for patients with Gilbert's disease
- •d. Estimated creatinine clearance (CrCL) >or = 40 mL/min (calculated using the Cockcroft-Gault formula)
- •e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < or =2.5 × ULN.
- •7. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of study drug.
- •Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or bilateral oophorectomy or hysterectomy.
- •8. Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
- •9. Patients must be willing and able to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
Exclusion Criteria
- •1. History of another invasive malignancy that has not been in remission for at least 1 year. The following are exempt from the 1-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ (DCIS), and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.
- •2. History of progressive multifocal leukoencephalopathy (PML).
- •3. Cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system (CNS) disease has been definitively treated.
- •4. Any active Grade 3 or higher (per the National Cancer Institute [NCI, US] Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. Routine antimicrobial prophylaxis is
- •5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug. Concomitant use of other systemic antineoplastic agents (including bleomycin) while on study is excluded.
- •6. Females who are pregnant or breastfeeding.
- •7. Known hypersensitivity to any study drug or excipient contained in the drug formulation of any of the study drugs.
- •8. Known to be positive for hepatitis B by surface antigen expression (HBsAg) and hepatitis B core antibody (HBcAb). Known to have active hepatitis C infection (positive by polymerase chain reaction) or on antiviral therapy for hepatitis C within the last 6 months.
- •9. Known to be positive for human immunodeficiency virus (HIV).
- •10. Patients with previous allogeneic SCT.
- •11. Previous treatment with brentuximab vedotin or bendamustine.
- •12. Intolerable toxicity to prior rituximab therapy (per Investigator discretion).
- •13. Current therapy with other investigational agents.
- •14. Grade 3 or higher pulmonary disease unrelated to underlying malignancy.
- •15. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association
- •(NYHA) Class III-IV within 6 months prior to the first dose of brentuximab vedotin.
- •16. Congestive heart failure, Class III or IV, by the NYHA criteria.
- •17. Grade 2 or higher (per NCI CTCAE, Version 4.03) peripheral sensory or motor neuropathy at baseline.
- •18. Major surgery less than 30 days prior to first dose of study drug. Major surgery is any invasive operative procedure in which a more extensive resection is performed, eg, a body cavity is entered, organs are removed, or normal anatomy is altered.
- •19. Live vaccines (in particular yellow fever vaccination) within 1 month prior to the first dose of study drug.
- •20. Current severe immunodeficiency, or history of recurring or chronic infections, or underlying conditions which may further predispose patients to serious infection.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A study to compare the safety and efficiacy of Brentuximab Vedotin when given with Bendamustine and Rituximab, compared to Bendamustine and Rituximab only in patients with relapsed or refactory CD-30 positive diffuse large B cell lymphomaEUCTR2015-001671-51-FRSeattle Genetics, Inc.110
Active, not recruiting
Phase 1
A study to compare the safety and efficiacy of Brentuximab Vedotin when given with Bendamustine and Rituximab, compared to Bendamustine and Rituximab only in patients with relapsed or refactory CD-30 positive diffuse large B cell lymphomaRelapsed or Refractory CD30-Positive Diffuse Large B-Cell LymphomaMedDRA version: 19.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001671-51-CZSeattle Genetics, Inc.110
Active, not recruiting
Phase 1
A study to compare the safety and efficiacy of Brentuximab Vedotin when given with Bendamustine and Rituximab, compared to Bendamustine and Rituximab only in patients with CD-30 positive diffuse large B cell lymphoma that has returned or is non-responsive to the last round of treatment.EUCTR2015-001671-51-GBSeattle Genetics, Inc.25
Active, not recruiting
Phase 1
A study to compare the safety and efficiacy of Brentuximab Vedotin when given with Bendamustine and Rituximab, compared to Bendamustine and Rituximab only in patients with relapsed or refactory CD-30 positive diffuse large B cell lymphomaEUCTR2015-001671-51-PLSeattle Genetics, Inc.110
Active, not recruiting
Phase 2
Rituximab adjunctive therapy for Burkitt's lymphomaBurkitt's lymphomaCancerISRCTN90296187niversity of Malawi College of Medicine220