Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)



Status:Active, not recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/1/2018
Start Date:November 21, 2013
End Date:December 28, 2021

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A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

This double-blind randomized, parallel group study will evaluate the efficacy and safety of
lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients
with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be
randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination
with rituximab. Anticipated time on study treatment is 1 year.

Indolent lymphoma is a slow growing but incurable lymphoma which includes follicular lymphoma
and marginal zone lymphoma. Follicular Lymphoma and Marginal zone lymphoma are cancers of the
B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug
that affects the immune system) which alters the body's immune system and it may also
interfere with the development of tiny blood vessels involved in tumor growth. Therefore,
lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been
shown to restore the immune cells' ability to attack and kill tumor cells, an ability that
may be inhibited by follicular lymphoma and other lymphomas. The combination of rituximab and
lenalidomide may eliminate the cancer while restoring the immune system's ability to attack
tumor cells.

Inclusion Criteria:

- Age ≥18 years at the time of signing the informed consent document.

- Understand and voluntarily sign an informed consent document prior to any study
related assessments/procedures are conducted.

- Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or
3a; CD20+ by flow cytometry or histochemistry).

- Previously treated with at least one prior systemic chemotherapy, immunotherapy or
chemoimmunotherapy and have received at least 2 previous doses of rituximab.

- Documented relapsed, refractory or progressive disease after treatment with systemic
therapy and must not be Rituximab-refractory.

- Investigator considers rituximab monotherapy appropriate.

- Bi-dimensionally measurable disease on cross sectional imaging by X-ray Computed
Tomography (CT) or Magnetic Resonance Imaging (MRI).

- Need of treatment for relapsed, progressed or refractory disease as assessed by the
investigator.

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

- Adequate bone marrow function.

- Willingness to follow study visit schedule, pregnancy precautions and other protocol
requirements.

Exclusion Criteria:

- Histology other than follicular or marginal zone lymphoma or clinical evidence of
transformation or Grade 3b follicular lymphoma.

- Subjects taking corticosteroids during the last week prior to study treatment, unless
administered at a dose equivalent to < 20 mg/day prednisone or prednisolone.

- Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks
use of radioimmunotherapy within 6 months.

- Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and
human immunodeficiency virus (HIV).

- Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with
HCV hepatitis requiring anti-viral medication (at time of randomization).

- Life expectancy < 6 months.

- Known sensitivity or allergy to murine products.

- Prior history of malignancies, other than follicular or marginal zone lymphoma, unless
the subject has been free of the disease for ≥ 5 years.

- Prior use of lenalidomide.

- Known allergy to thalidomide.

- Neuropathy > Grade 1.

- Presence or history of central nervous system involvement by lymphoma.

- Subjects who are at a risk for a thromboembolic event and are not willing to take
prophylaxis for it.

- Uncontrolled intercurrent illness.

- Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent document.

- Pregnant or lactating females.

- Any condition that places the subject at unacceptable risk if he/she were to
participate in the study or that confounds the ability to interpret data from the
study.
We found this trial at
35
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Des Moines, Iowa 50309
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Sacramento, California 95814
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Arlington, Texas 76012
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Brugge,
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Escondido, California 92025
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Glendale, Arizona 85306
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Greenbrae, California 94904
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Greenville, South Carolina 29601
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Hooksett, New Hampshire 03106
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Houston, Texas 77030
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La Verne, California 91750
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Laconia, Indiana 03246
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Morristown, New Jersey 07960
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Nashville, Tennessee 37203
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New York, New York 10021
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Peoria, Illinois 61656
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Rochester, Minnesota 55905
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Saint Cloud, Minnesota 56303
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Southfield, Michigan 48075
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Southington, Connecticut 06489
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750 East Adams Street
Syracuse, New York 13210
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Tacoma, Washington 98405
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West Hills, California 91307
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Winston-Salem, North Carolina 27157
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