Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/31/2018 |
| Start Date: | May 2012 |
| End Date: | September 15, 2018 |
Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765), in Waldenstrom's Macroglobulinemia
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.
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.
Patients in this research study will receive up to 26 cycles of treatment. Each treatment
cycle lasts 4 weeks. Patients will take PCI-32765 by mouth, once a day in the morning.
During each cycle patients will be asked to visit the clinic for scheduled tests and exams
and to receive a supply of PCI-32765 to take at home every day. Patients will visit the
clinic on the first day of each of the first 3 cycles, and then just once at the beginning of
every three cycles.
During study visits, patients will have a physical exam where they will be asked questions
about their general health and specific questions about any problems that they might be
having and any medications they may be taking. Patients will have blood tests to see how
their disease is responding to the study treatment and how they are tolerating the study
drug. Patients may also have CT scans of the chest, abdomen and pelvis as well as a bone
marrow aspirate and biopsy. If a patient's disease stays the same or is helped, he/she will
continue to get study treatment. If disease worsens, he/she will be taken off study treatment
at that time.
After completion of the treatment and as part of standard of care, follow-up tests will
include a physical exam, review of symptoms and medications, blood tests, bone marrow
aspirate and biopsy, CT scans of the chest, abdomen and pelvis. The investigators would like
to continue to monitor progress by following-up every three months for up to two years after
completion of the study.
cycle lasts 4 weeks. Patients will take PCI-32765 by mouth, once a day in the morning.
During each cycle patients will be asked to visit the clinic for scheduled tests and exams
and to receive a supply of PCI-32765 to take at home every day. Patients will visit the
clinic on the first day of each of the first 3 cycles, and then just once at the beginning of
every three cycles.
During study visits, patients will have a physical exam where they will be asked questions
about their general health and specific questions about any problems that they might be
having and any medications they may be taking. Patients will have blood tests to see how
their disease is responding to the study treatment and how they are tolerating the study
drug. Patients may also have CT scans of the chest, abdomen and pelvis as well as a bone
marrow aspirate and biopsy. If a patient's disease stays the same or is helped, he/she will
continue to get study treatment. If disease worsens, he/she will be taken off study treatment
at that time.
After completion of the treatment and as part of standard of care, follow-up tests will
include a physical exam, review of symptoms and medications, blood tests, bone marrow
aspirate and biopsy, CT scans of the chest, abdomen and pelvis. The investigators would like
to continue to monitor progress by following-up every three months for up to two years after
completion of the study.
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
We found this trial at
4
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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