Waldenstrom's Macroglobulinemia Clinical Trial
Official title:
Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765), in Waldenstrom's Macroglobulinemia
NCT number | NCT01614821 |
Other study ID # | 12-015 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2012 |
Est. completion date | September 15, 2018 |
Verified date | January 2020 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in
treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and
that research doctors are trying to find out more about it-such as the safest dose to use,
the side effects it may cause, and if PCI-32765 is effective for treating different types of
cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients,
including people with Waldenstrom's Macroglobulinemia.
PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.
PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor
(BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein,
which then results in malignant cell death. This drug has been used in laboratory experiments
and other research studies in B-cell malignancies and information from those other research
studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies,
including Waldenstrom's Macroglobulinemia.
In this research study, the investigators are testing the safety and efficacy of PCI-32765 as
a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.
Status | Completed |
Enrollment | 63 |
Est. completion date | September 15, 2018 |
Est. primary completion date | September 9, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia - Measurable disease - Have received at least one prior therapy for WM therapies - Disease free of prior malignancies - Able to adhere to study visit schedule and other protocol requirement Exclusion Criteria: - Pregnant or breastfeeding - Any other serious medical condition - Concurrent use of other anti-cancer agents or treatments - Prior exposure to PCI-32765 - Known CNS lymphoma - Significant cardiovascular disease - Any disease affecting gastrointestinal function |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | To assess the overall response rate (>25% reduction in serum IgM from baseline). | 4 years | |
Secondary | Safety and Tolerability of PCI-32765 | To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade > or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event. | 4 years | |
Secondary | Determine Progression Free Survival | To determine Progression Free Survival (PFS in symptomatic WM patients with relapsed/refractory disease. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. 40 participants were censored prior to disease progression. | 6 years | |
Secondary | To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease | Time to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy. | 6 years | |
Secondary | Major Response Rates | To assess the major response rate (>50% reduction in serum IgM from baseline) | 4 years | |
Secondary | Very Good Partial Response Rate | To assess the very good partial response rate (>90% reduction in serum IgM from baseline) | 4 years |
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