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Diffuse Large B Cell LymphomaPhase 2NCT02955628

RICE-ibrutinib in Relapsed DLBCL

A Phase 2 study testing Ibrutinib-RICE in people with Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma Recurrent, run by Singapore General Hospital at 4 sites in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
What is being tested?
Ibrutinib-RICE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesSingapore
Study dates
13 Dec 2016to Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
  • Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
  • Must be able to adhere to study visit schedules and other protocol requirements.
  • Male subject agrees to use an acceptable method for contraception for the duration of the study.

Who cannot join

  • 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).
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  • 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.
  • Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.

Trial locations and contacts

4 sites in 1 country.

Colin Phipps, MD contact

6562223322

Colin.phipps.diong@singhealth.com.sg

Singapore4 sites, 4 recruiting

  • National University Hospital Singapore

    Singapore, 119074

    Michelle Poon, MD, 6567795555, NUH_Enquiries@nuhs.edu.sg

    Not yet recruiting

  • Singapore General Hospital

    Singapore, 169608

    Colin Phipps, MD, 6562223322, Colin.phipps.diong@singhealth.com.sg

    Recruiting

  • National Cancer Centre Singapore

    Singapore, 169610

    Tiffany Tang, MD, 6564368000, Callcentre@nccs.com.sg

    Not yet recruiting

  • Raffles Hospital Singapore

    Singapore, 188770

    Daryl Tan, MD, 6563111111

    Daryl.Tan.c.l@sgh.com.sg

    Not yet recruiting

Other trials in Singapore

About this study

Official title: A Phase II Study of Ibrutinib With R-ICE Chemotherapy for Transplant-eligible Relapsed/Refractory Diffuse Large B-cell Lymphoma Followed by Ibrutinib Maintenance in Patients Not Achieving a Complete Response at Pre-transplant Interim Assessment

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.

Read the detailed description

All patients will receive R-ICE therapy for 2 cycles followed by PET-CT assessment (PET-2). Ibrutinib 560 mg will be added to the RICE regimen based on results of PET-2 as follows:

  • Patients in CR will continue with 2 more cycles of R-ICE and proceed onto ASCT. These patients will not receive ibrutinib.
  • In patients with stable disease or achieving a response that is less than CR, ibrutinib 560 mg will be added. The combination of ibrutinib-RICE will be given for 2 cycles and will be followed by PET-CT assessment (PET-4). Patients who achieve ≥ PR at this point will proceed onto ASCT.
  • Patients who have disease progression will be removed from the trial. Hematopoietic stem cell harvesting can be performed following count recovery at any cycle of R-ICE, but preferably cycle 2.

Transplant conditioning regimen will be with standard BEAM chemotherapy (carmustine, etoposide, cytarabine, melphalan).

Following ASCT, ibrutinib will be given as maintenance therapy for patients who did not achieve a CR at the time of PET-2 assessment. This will be continued for up to 1 year after ASCT.

Being tested
Ibrutinib-RICE
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibrutinib-RICEDrug

    Also called Imbruvica

    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.

Study groups in NCT02955628
Study groupRoleWhat they receive
Ibrutinib-RICEExperimentalPatients 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.
Receives: Drug: Ibrutinib-RICE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (3)

  1. Progression-free survival

    Progression-free survival is defined as the time from enrolment to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.

    Measured: 3 years

  2. Overall survival

    Overall survival is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: 3 years

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

    Reported as percentage of patients achieving a complete remission of the total patients starting ibrutinib.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2016 (estimated)
  2. Study start13 Dec 2016
  3. Primary completionAug 2023 (estimated)
  4. Study completionAug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02955628
Sponsor's protocol ID
SGH-LYM-15-02
Status last verified
Nov 2016
First submitted
27 Oct 2016
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib-RICE in people with Diffuse Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma Recurrent, run by Singapore General Hospital at 4 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Colin Phipps, MD (6562223322, Colin.phipps.diong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy as measured by event free survival measured at 3-years follow up of patients who have received ibrutinib (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02955628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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