Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia
|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: NCT03620903|
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom Macroglobulinemia||Drug: Ibrutinib||Phase 2|
In Waldenström's macroglobulinemia (WM) conventional chemotherapy induces only low complete remission (CR) rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. Today, chemotherapy in combination with the anti-cluster of differentiation (CD) 20 antibody rituximab is still the backbone of treatment in patients with WM and is recommended as first line in national and international treatment guidelines. With the approval of Ibrutinib by the European Medicines Agency (EMA) 2015 for patients with relapsed WM or for patients not eligible for chemotherapy with treatment naïve WM treatment landscape has changed in this lymphoma subtype and there is an urgent need to evaluate to which extent chemotherapy-free approaches add clinical benefit to the patient. The treatment in the "European Consortium for Waldenström's Macroglobulinemia" (ECWM)-2 trial will test, whether the chemotherapy-free approach, which is given orally (ibrutinib) and subcutaneously (bortezomib and rituximab from cycle 2 onwards) (B-RI) will approach the efficacy of chemotherapy containing treatment concepts, but avoids chemotherapy associated toxicity. From the perspective of single agent ibrutinib, this regimen tests whether ibrutinib can be further optimized by adding rituximab and bortezomib. The combination of rituximab and ibrutinib was tested in comparison to rituximab/placebo in a large international phase III trial on behalf of the European Consortium for Waldenström's Macroglobulinemia in relapsed and first line WM, and results were recently published: in this trial no unexpected toxicity of the combination ibrutinib/rituximab was reported. Furthermore, ibrutinib/rituximab was significantly superior to rituximab/placebo with regard to response rates and PFS. From the perspective of the established rituximab/bortezomib regimen, the combination of B-RI will evaluate whether adding ibrutinib to this combination will add any benefit for the patient.
To this end, the aim of the study is to assess the toxicity and efficacy of B-RI in an exploratory phase II trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of First Line Bortezomib, Rituximab, Ibrutinib (B-RI) for Patients With Treatment Naive Waldenström's Macroglobulinemia|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2024|
Rituximab: 375 mg/m2 intravenously (i.v) day 1 Bortezomib:1.6 mg/ m2 subcutanously (SC) day 1,8,15 Ibrutinib: 420 mg orally (p.o.) day 1-28
Cycle 2-6 Rituximab: 1400 mg absolute SC day 1 Bortezomib:1.6 mg/ m2 SC day 1,8,15 Ibrutinib: 420 mg p.o. day 1-28
Ibrutinib 420 mg p.o. daily, until evidence of progressive disease or no longer tolerated by the subject Rituximab 1400 mg absolute SC day 1, every second month for 24 months (month 7-30)
First line treatment in Waldenstrom Macroglobulinemia
- 1 year progression free survival [ Time Frame: 1 year ]The primary endpoint is the rate of 1 year progression free survival (1YPFS).
- Response rate [ Time Frame: 6 months ]overall response rate including CR, very good partial remission (VGPR), partial remission (PR) and minor response (MR)
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): NCT03620903
|Contact: Christian Buske, MDemail@example.com|
|Contact: Jennifer Kelpfirstname.lastname@example.org|