RICE-ibrutinib in Relapsed DLBCL

Sponsor
Singapore General Hospital
Study ID
NCT02955628
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma Recurrent

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 13, 2016
Status verified
Nov 2016
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib-RICE
    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.

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 ]

Central Contacts

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