RICE-ibrutinib in Relapsed DLBCL

NCT02955628 | Unknown Phase 2 DMC

• 1 other identifier: SGH-LYM-15-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicentre, open-label, phase II study of ibrutinib 560 mg in combination with R-ICE for treatment of transplant-eligible relapsed/refractory diffuse large B-cell lymphoma.

Conditions

Diffuse Large B Cell Lymphoma; Diffuse Large B-Cell Lymphoma Recurrent

Outcome Measures

Primary Outcomes (1)

• Efficacy as measured by event free survival measured at 3-years follow up of patients who have received ibrutinib

  Event-free survival is defined as time from diagnosis until relapse or progression, unplanned re-treatment of lymphoma after initial immunochemotherapy, or death as a result of any cause.

  3 years

Secondary Outcomes (3)

• Progression-free survival

  3 years

• Overall survival

  3 years

• Percentage of patients who have increased response from partial remission to complete remission ibrutinib before transplant

  6 weeks

Study Arms (1)

Ibrutinib-RICE

EXPERIMENTAL

Patients not achieving a complete remission at time of PET-2 will receive ibrutinib and proceed on to autologous transplant if at least a partial remission is achieved. After transplantation, ibrutinib will be continued for up to 1 year. Autologous transplantation will be with BEAM conditioning.

Drug: Ibrutinib-RICE

Interventions

Ibrutinib-RICE DRUG

Ibrutinib will be added to RICE regimen for patients not achieving a complete remission at interim PET-2. Ibrutinib will be continued for up to 1 year after autologous transplantation.

Also known as: Imbruvica

Ibrutinib-RICE

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven relapsed or refractory DLBCL (including transformed DLBCL)
• Patients who are eligible for autologous stem cell transplant as deemed by the Bone Marrow Transplant Team in the participating cites.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix A).
• Minimum life expectancy of 6 months.
• Previously treated with anthracycline-based chemotherapy (unless contraindicated) with rituximab Written informed consent
• Must be at least 21 years old and able to sign informed consent form.
• Adequate hematological function within 30 days prior to signing informed consent, including:
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/mm3) independent of growth factor support
• Platelets ≥ 100,000/mm3 or ≥ 50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
• Hemoglobin ≥ 8 g/dL
• Biochemical values within the following limits:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
• Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault) ≥ 40 mL/min/1.73m2
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.

You may not qualify if:

• Concomitant use of any other investigational agent.
• Contraindication to any drug contained in the regimen.
• Myocardial infarction within 6 months prior to enrolment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Clinically significant active infection.
• Patients who are pregnant or breast-feeding.
• Coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix).
• Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
• Major surgery within 4 weeks of randomization.
• Known central nervous system lymphoma.
• History of stroke or intracranial hemorrhage within 6 months prior to randomization.
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon).
• Requires treatment with strong CYP3A inhibitors.
• Known inherited platelet function disorder.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
• Vaccinated with live, attenuated vaccines within 4 weeks of randomization.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Janssen, LP: collaborator

Study Sites (4)

National University Hospital Singapore

Singapore, 119074, Singapore

NOT YET RECRUITING

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

National Cancer Centre Singapore

Singapore, 169610, Singapore

NOT YET RECRUITING

Raffles Hospital Singapore

Singapore, 188770, Singapore

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Colin Phipps, MD

CONTACT

6562223322; Colin.phipps.diong@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 4, 2016
• Study Start: December 13, 2016
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 14, 2017

Record last verified: 2016-11

Locations

SG (4)