RICE-ibrutinib in Relapsed DLBCL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02955628|
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma Diffuse Large B-Cell Lymphoma Recurrent||Drug: Ibrutinib-RICE||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 13, 2016|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
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.
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.
Other Name: Imbruvica
- Efficacy as measured by event free survival measured at 3-years follow up of patients who have received ibrutinib [ Time Frame: 3 years ]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.
- Progression-free survival [ Time Frame: 3 years ]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.
- Overall survival [ Time Frame: 3 years ]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.
- Percentage of patients who have increased response from partial remission to complete remission ibrutinib before transplant [ Time Frame: 6 weeks ]Reported as percentage of patients achieving a complete remission of the total patients starting ibrutinib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955628
|Contact: Colin Phipps, MD||6562223322||Colin.firstname.lastname@example.org|
|National University Hospital Singapore||Not yet recruiting|
|Singapore City, Singapore, 119074|
|Contact: Michelle Poon, MD 6567795555 NUH_Enquiries@nuhs.edu.sg|
|National Cancer Centre Singapore||Not yet recruiting|
|Singapore City, Singapore, 169610|
|Contact: Tiffany Tang, MD 6564368000 Callcentre@nccs.com.sg|
|Raffles Hospital Singapore||Not yet recruiting|
|Singapore City, Singapore, 188770|
|Contact: Daryl Tan, MD 6563111111|
|Singapore General Hospital||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Colin Phipps, MD 6562223322 Colin.email@example.com|