Patients who require anticoagulation with warfarin or equivalent vitamin K antagonists are not eligible
Participants with ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonists (example phenprocoumon), or ongoing treatment with agents known to be strong CYP3A4/5 inhibitors, or has taken any disallowed therapies as noted in Section 8.2, Prohibited Medications, before the planned first dose of study drug
Treatment with warfarin or other vitamin K antagonists (eg, phenprocoumon)
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon); patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant
Requires anticoagulation with warfarin or other vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon)
Systemic anticoagulation with warfarin or other Vitamin K antagonists.
Requires therapeutic anticoagulation with warfarin or other vitamin K antagonists
Requires or is currently receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 28 days of first dose of study drug
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonist
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
Relapsed/refractory MCL: Requires anticoagulation with warfarin or equivalent vitamin K antagonist
Newly diagnosed MCL: Requires concomitant anticoagulation with warfarin or equivalent vitamin K antagonist
Patients who require warfarin or other vitamin K antagonists for anticoagulation (other anticoagulants are allowed after consultation with the principal investigator)
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Need for anticoagulation with a vitamin K antagonist (warfarin); other anticoagulants and\r\nantiplatelet agents are allowed
Requires concomitant anticoagulation with warfarin or equivalent vitamin K antagonist.
Received anticoagulation therapy with warfarin, or equivalent vitamin K antagonists, within the last 28 days prior to day 1 of ibrutinib; patients with familial coagulopathic diseases (e.g. hemophilia, von Willebrand disease) are also excluded; if applicable, subjects must discontinue fish oil and vitamin E supplements within 7 days prior to initiating ibrutinib therapy
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
Treatment by warfarin or equivalent vitamin K antagonists.
Therapeutic anticoagulation with Vitamin-K antagonists (eg, warfarin) or with heparins and heparinoids. o However, prophylactic anticoagulation as described below is allowed:
Subjects requiring anticoagulation with warfarin or vitamin K antagonists are excluded from the ibrutinib arm; if previously on these drugs and switched, international normalized ratio (INR) must be normal for 7 days prior to enrollment
Requirement for anticoagulation with warfarin or similar vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon); if patients have been on warfarin or equivalent vitamin K antagonists in the past, they will not be eligible if administered within 30 days of the first dose of study drug
Patients who require warfarin anticoagulation or who have received warfarin or equivalent vitamin K antagonists =< 7 days prior to treatment day 1; patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant
Requires treatment with anticoagulation with warfarin or equivalent vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonist
Subjects that have received anticoagulation therapy with warfarin or equivalent vitamin K antagonists within the last 28 days are not eligible
Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
Patients requiring any therapeutic anticoagulation are excluded; patients who have received warfarin or other vitamin K antagonists within 28 days or are taking warfarin or other vitamin K antagonists are not eligible
Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g.: phenprocoumon) within 28 days of the first dose of study drug
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Requires anticoagulation with warfarin or equivalent vitamin K antagonists or treatment with strong CYP3A4/5 inhibitors
Patients requiring anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 28 days from the start of study drug cannot be treated with ibrutinib but idelalisib would be an option
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Received anticoagulation therapy with warfarin or equivalent vitamin K antagonists within the last 28 days
Anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days prior to starting ibrutinib and throughout the study
Received anticoagulation therapy with Coumadin or equivalent vitamin K antagonists within the last 28 days
Anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon); Note: use of low molecular weight heparin (or any anticoagulation agent) is allowed provided there is no history of bleeding (minor or major) =< 12 months prior to registration; the treating physician should discuss the case with the study chair
Treatment with warfarin or other vitamin K antagonists; patients who are on active treatment with warfarin or other vitamin K antagonists for conditions requiring anticoagulation will be switched, when not contraindicated, to a different form of anticoagulation, including low molecular weight heparin (LMWH)s (ex: enoxaparin, dalteparin) or oral anti-Xa drugs (ex: rivaroxaban or apixaban) Patients who switch to these alternative forms of anticoagulation will be eligible
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
Patients who require warfarin or other vitamin K antagonists for anticoagulation (other anticoagulants are allowed after consultation with the principal investigator)
Patients who require warfarin or other vitamin K antagonists for anticoagulation (other anticoagulants are allowed)
Requires anticoagulation with warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Supplementation with vitamin E greater than 100% of the daily recommended dose
Vitamin D3 supplementation at > 2,000 IU daily
Concomitant use of warfarin or other vitamin K antagonists
Requires vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. Factor Xa antagonists are permitted.
No supplementation with vitamin E is permitted because the selumetinib capsules contain vitamin E
Concomitant use of warfarin or other vitamin K antagonists
Current use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other Vitamin K antagonists
On warfarin therapy or other vitamin K antagonists within 7 days of treatment initiation
Concomitant use of warfarin or other vitamin K antagonists; Note: Subjects receiving antiplatelet agents in conjunction with ibrutinib should be observed closely for any signs of bleeding or bruising, and ibrutinib should be withheld in the event of any bleeding events; supplements such as fish oil and vitamin E preparations should be avoided
No supplementation with vitamin E is permitted
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Willing to stop current supplemental vitamin D (multivitamin with vitamin D component is acceptable)
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Not willing to discontinue use of supplemental vitamin E
3 or more doses of a vitamin K antagonist before randomization;
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists within the last 28 days
concomitant use of warfarin or other Vitamin K antagonists
Requires anti-coagulation with warfarin or a vitamin K antagonist
The use of concomitant antioxidants, such as vitamin C or E, is not allowed
Concomitant use of anticoagulants including warfarin, other vitamin K antagonists, and enoxaparin
No use of warfarin or similar vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Patients requiring a treatment by oral vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other Vitamin K antagonists
Patients may not have received warfarin or another vitamin K antagonist in the preceding 30 days
Bleeding diathesis or use of warfarin or other vitamin K antagonist
Use of any non-protocol vitamin D supplementation
Have a history of vitamin B12 deficiency
Patients on vitamin K antagonist warfarin
Regular use of vitamin D supplements >= 2,000 IU per day in the past year; use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed while enrolled on this clinical trial \r\n* In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator; vitamin D levels will be assayed only as part of the research blood samples collected during the study; if there are concerns related to a participant’s vitamin D status, the lead principal investigator should be contacted for further discussion
Concurrent use of warfarin or other vitamin K antagonists
Concomitant use of warfarin or other vitamin K antagonists (for patients who are discontinuing warfarin or other vitamin K antagonists, a wash-out period of 5 effective half-lives is required prior to 1st dose of ibrutinib)
Concomitant use of warfarin or other Vitamin K antagonists.
Concomitant use of warfarin or other vitamin K antagonists
Use of concomitant anticoagulation with warfarin or other vitamin K antagonists is prohibited, as is treatment with these agents in the 7 days prior to signing the ICD. The use of other anticoagulants (eg, heparins) and anti-platelet agents is allowed per investigator's discretion. Arm C only (CC-122 in combination with obinutuzumab):
Prothrombin time (PT) >1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
Requires anti-coagulation with warfarin or a vitamin K antagonist.
Concurrent use of warfarin or other vitamin K antagonists
Supplementation with vitamin E greater than 100% of the daily recommended dose; any multivitamin containing vitamin E must be stopped prior to initiation of therapy
Patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of Photofrin®, including:\r\n* Beta-carotene\r\n* Lutein\r\n* Lycopene\r\n* Selenium\r\n* Vitamin A\r\n* Vitamin C\r\n* Vitamin E
Able to obtain and take an acceptable form of vitamin B6.
Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses > 10 mg.
Subjects receiving ?2000 IU/day vitamin D (ergocalciferol or cholecalciferol) therapy must remain on a stable dose during the study. If taking more than 2000 IU/day of vitamin D (ergocalciferol or cholecalciferol), must be willing and able to reduce use to ?2000 IU/day and remain on a stable dose for the duration of the study
Severe vitamin D deficiency with serum 25-OH vitamin D < 10 ng/ml (25 nmol/l) \r\n* Patients with vitamin D levels < 10 ng/ml may be treated with vitamin D and reconsidered for enrollment when levels are sufficient
Concomitant use of warfarin or other vitamin K antagonists
Patients on vitamin K antagonist (i.e., warfarin)
Patients receiving vitamin K antagonist (warfarin)
Patients on vitamin K antagonist warfarin
Currently consuming 800 IU or more of vitamin D a day
Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment in step 1
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Requirement for anticoagulation with warfarin or other vitamin K antagonists (concomitant use of other anticoagulants is permitted)
Patients on a stable (>= 4 week duration) dose of > 2000 IU/day (or equivalent) of vitamin D supplementation
Willingness to avoid alternative/additional vitamin D3 supplementation for the duration of the trial
Vitamin D supplementation > 2,000 IU/day of vitamin D within 30 days prior to enrollment
Patients taking Vitamin D supplements during the study, unless they have been taking Vitamin D supplements for 30 days or more prior to the start of the study and that the dose of the Vitamin D supplement remain the same throughout the study.
Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis)
Vitamin B12, folate or vitamin A deficiency. Rescreening following repletion therapy is acceptable.
Regular use of supplemental vitamin D totaling >= 2,000 IU/day in the past year\r\n* Use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed during the treatment period of this clinical trial\r\n* In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator; vitamin D levels will be assayed only as part of the research blood samples collected during the study; if there are concerns related to a participant’s vitamin D status, the lead principal investigator should be contacted for further discussion