A Phase 2 Multicenter, Open-label, Single-arm Study of KTE-C19 in Japanese Patients with Refractory or Relapsed Large B Cell Lymphoma
- Conditions
- Refractory or relapsed (relapse after transplant or relapse after medication in patients ineligible for transplant) diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) or High-grade B cell lymphoma
- Registration Number
- JPRN-jRCT1080223858
- Lead Sponsor
- Gilead Sciences K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 10
A subject who satisfies all the criteria below will be enrolled in the study.
1)Histologically confirmed aggressive B-cell NHL (including the following types defined by the WHO 2016)
i)DLBCL
a)DLBCL, NOS
- Germinal center B-cell lymphoma
- Activated B-cell lymphoma
b)Intravascular large B-cell lymphoma
c)T-cell/histiocyte-rich large B-cell lymphoma
d)DLBCL associated with chronic inflammation
e)Epstein-Barr virus (EBV)positive diffuse large B-cell lymphoma, NOS
ii)PMBCL
iii)TFL
iv)High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement
v)High-grade B-cell lymphoma, NOS
2)Chemotherapy-refractory disease, defined as one or more of the following:
i)No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded
a)Progressive Disease (PD) as best response to first-line therapy
b)Stable Disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) with SD duration no longer than 6 months from last dose of therapy
ii)No response to second or greater lines of therapy
a)PD as best response to most recent therapy regimen
b)SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy
iii)Relapsed post-ASCT
a)Disease progression or relapsed =< 12 months of ASCT (must have biopsy proven relapse in relapsed subjects)
b)if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy (must have biopsy proven recurrence in relapsed subjects)
3)Subjects must have received at least the following therapy:
i)Anti-CD20 monoclonal antibody (unless the investigator or subinvestigator determines that tumor is CD20 negative)
ii)An anthracycline containing chemotherapy regimen;
iii)Prior chemotherapy for follicular lymphoma for subjects with transformed TFL (subsequently have a chemorefractory disease after transformation to DLBCL)
4)At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
A patient who meets any of the following criteria is not eligible.
1)History of malignancy within the past 3 years (patients with skin cancer [except for melanoma] or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma are eligible even with a history within 3 years)
2)History of Richter's transformation of CLL
3)Autologous stem cell transplant within 6 weeks of planned KTE-C19 infusion
4)History of allogeneic stem cell transplant
5)Prior CD19 targeted therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study)
6)Prior CAR T cell therapy or other genetically modified T cell therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>- ORR (percentage of patients judged CR or PR) assessed by the investigator or subinvestigator based on the criteria of the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>other<br>- ORR assessed by the central image evaluation organization<br>- DOR<br>- PFS<br>- OS