Datum der Studienregistrierung
05.10.2017
Einschluss der ersten teilnehmenden Person
07.11.2017
Rekrutierungsstatus
Not Recruiting
Wissenschaftlicher Titel
(Datenquelle: WHO)
A PHASE II STUDY EXPLORING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB ADMINISTERED IN COMBINATION WITH OBINUTUZUMAB OR RITUXIMAB ANTI-CD20 THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA, MARGINAL ZONE LYMPHOMA AND WALDENSTRÖM MACROGLOBULINEMIA
Studientyp
(Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie
(Datenquelle: WHO)
Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 3
Phase
(Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no
Primäre Endpunkte
(Datenquelle: WHO)
Main Objective: To evaluate the efficacy of atezolizumab in combination with obinutuzumab or rituximab;Secondary Objective: • To evaluate the efficacy of atezolizumab in combination with obinutuzumab or rituximab
• To evaluate the safety and tolerability of atezolizumab in combination with obinutuzumab or rituximab
• To characterize the pharmacokinetics of atezolizumab and obinutuzumab when administered in combination in MCL and WM patients
• To characterize the pharmacokinetics of atezolizumab and rituximab when administered in combination in MZL patients
• To evaluate the immune response to atezolizumab with obinutuzumab or rituximab
;Primary end point(s): 1. For MCL and nodal and extra-nodal MZL, objective response (OR) at end of Induction, defined as a complete response (CR) or partial response (PR) based on modified Cheson 2007 criteria (excluding PET)
2. For WM, best overall objective response (BOR), defined as a CR, very good partial response, PR, or minimum response, based on Owen 2013 criteria, at any time during the study
3. For gastric MZL, OR at end of Induction, defined as a CR or probable minimal residual disease or responding residual disease, based on the histological grading system of GELA 2003 criteria
4. For splenic MZL, OR at end of Induction, defined as a CR or PR based on Matutes (2008);Timepoint(s) of evaluation of this end point: 1, 3 & 4. At the end of induction
2. At any time during the study; up to approximately 54 months
Sekundäre Endpunkte
(Datenquelle: WHO)
Secondary end point(s): 1. Progression-free survival (PFS), defined as the time from enrolment to the first occurrence of PD or death from any cause, whichever occurs
first, as determined by the investigator
2. BOR, defined as best response seen throughout study
3. Complete Response Rate defined as best response of CR
4. Duration of objective response, defined for responding patients as the
time from first occurrence of a documented objective response to the
time of progression or death from any cause, whichever occurs first as
determined by the investigator
5. Time to next treatment, defined as the time from the date of
enrolment to the start date of the next anti-lymphoma treatment (NALT)
or death from any cause, whichever occurs first
6. Overall survival, defined as the time from the enrolment to death from
any cause
7. Event free survival, defined as the time from enrolment to first
occurrence of disease progression or relapse, death from any cause, as
assessed by the investigator, or initiation of any non-protocol-specified
NALT, whichever occurs first.
8. Disease-free survival, defined as the time from the date of the first
occurrence of a documented CR to the date of disease progression,
relapse or death from any cause, whichever occurs first, as assessed by
the investigator, for the subgroup of patients with a BOR of CR
9. Safety: Incidence, nature and severity of adverse events (AEs),
graded according to the National Cancer Institute Common Terminology
Criteria for Adverse Events (NCI CTCAE v4.03)
10. Pharmacokinetic parameters of atezolizumab, obinutuzumab, and
rituximab
11. Occurrence of anti-drug antibodies of atezolizumab, obinutuzumab,
and rituximab;Timepoint(s) of evaluation of this end point: 1-9. Up to approximately 54 months
10. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C2D1, C4D1 (obinutuzumab); C1D1, C2D1, C4D1, C8D1 (rituximab), end of treatment (EOT) and at Follow-up 1 (FU1)
11. C1D1, C2D1, C34D1, C4D1, C8D1, C12D1, C16D1 (atezolizumab); C1D1, C4D1 (obinutuzumab); C1D1, C4D1 (rituximab); EOT and at FU1
Kontakt für Auskünfte
(Datenquelle: WHO)
F.Hoffman-La Roche Ltd.