Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Follow up phase will continue until either 100% of the patients have died, are lost to follow
up or have withdrawn consent or a maximum of 4 years from the last patient enrolled,
whichever comes first. All other efficacy and safety endpoints will be updated at this time.
In the unlikely event that the study will be closed and patients are still responding to
treatment at this time, Celgene will discuss with the treating physicians options to provide
further treatment to the patient after study closure in line with local regulation.
Follow up for second primary malignancies and OS will continue until 100% of the patients
have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the
last patient enrolled, whichever comes first.
10 October 2017: In regard to the last subject last visit date/study completion date, the
prolongation of timelines is due to the bridging of a treatment gap for a patient responding
to study medication until non-study medication is available.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
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Phase 1/Phase 2 | |
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Early Phase 1 |