Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2017 |
Start Date: | April 2015 |
End Date: | September 2016 |
A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
The objective of this study is to determine the effectiveness of lenalidomide in subjects
with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL
subjects who require treatment after receiving ibrutinib therapy are considered a population
with high unmet medical need. It is therefore of benefit to have data on the outcomes of
treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or
being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment
after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant
to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next
subsequent treatment after ibrutinib.
with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL
subjects who require treatment after receiving ibrutinib therapy are considered a population
with high unmet medical need. It is therefore of benefit to have data on the outcomes of
treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or
being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment
after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant
to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next
subsequent treatment after ibrutinib.
Inclusion Criteria:
1. Understand and voluntarily sign an informed consent document (ICD), if applicable,
prior to any collection of study-related data.
2. Males or females ≥ 18 years of age at the time of signing the ICD (if informed
consent is applicable)
3. Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a
pathology report establishing the diagnosis of MCL must be available
4. Must have received at least one dose of ibrutinib and must have met at least one of
the following criteria:
A. Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an
ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib
treatment at the time of relapse, and there is no upper limit on the time between the last
dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD
following initial response of PR to ibrutinib (or an ibrutinib-containing regimen).
Subjects may have discontinued or completed ibrutinib at the time of progression, and
there is no upper limit on the time between the last dose of ibrutinib to time of
progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD)
during treatment with ibrutinib (or an ibrutinib-containing regimen), and then
subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an
ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation
of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential
reasons for premature discontinuation may include Adverse Event (AE) attributed to
ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to
ibrutinib treatment must have documented PD/relapse following discontinuation of
ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.
Exclusion Criteria:
- no exclusion criteria.
We found this trial at
12
sites
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Ann Arbor, Michigan 48109
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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