Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma
Information source: Celgene Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkins Lymphoma
Intervention: CC-5013 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Celgene Corporation
Summary
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle.
Treatment will continue until for up to 52 weeks or until disease progression, subjects who
achieve a CR will receive an additional 2 cycles of treatment prior to discontinuation.
Subjects will be followed for progression free survival following discontinuation from the
treatment phase
Clinical Details
Official title: A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the activity of lenalidiomide in relapsed or refractory indolent non-Hodgkin’s lymphoma. Activity will be assessed by measuring the response rate, tumor control rate, duration of response and progression free survival.
Secondary outcome: To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory indolent NHL.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Understand and voluntarily sign an informed consent form.
2. Age greater than or equla to18 years at the time of signing the informed consent form
3. Able to adhere to the study visit schedule and other protocol requirements
4. Biopsy-proven non-Hodgkins lymphoma
5. Indolent lymphoma the following histologies are acceptable: a. Follicular center
lymphoma, grades 1, 2, b. Extranodal marginal zone B-cell lymphoma of MALT type, c.
Nodal marginal zone B-cell lymphoma d. Splenic marginal zone B-cell lymphoma, e.
Small lymphocytic lymphoma, f. Lymphoplasmacytoid lymphoma
6. Relapsed or refractory to previous therapy for lymphoma. Subjects must have received
at least one prior treatment regimen such as radiation, immunotherapy, chemotherapy,
OR radioimmunotherapy, and be ineligible or unwilling to undergo an autologous stem
cell transplant. There is no limit on the number of prior therapies
7. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm
in the longest diameter
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 (see
Appendix II).
9. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days of starting study drug. In addition, sexually active WCBP must
agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal
contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
spermicide; or vasectomized partner) while on study drug.
Exclusion Criteria:
1. Any of the following laboratory abnormalities
1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1. 5 x 109/L)
2. Platelet count <100,000/mm3 (100 x 109/L)
3. Serum creatinine >2. 5 mg/dL (221 mmol/L)
4. Serum SGOT/AST or SGPT/ALT >5. 0 x upper limit of normal (ULN)
5. Serum total bilirubin >2. 0 mg/dL (34 mmol/L)
2. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
3. All subjects with CNS disease with the exception of those subjects whose CNS disease
has been treated with chemotherapy, radiotherapy or surgery and remains asymptomatic,
with no active CNS disease, as shown by lumbar puncture, CT scan or MRI, for at least
6 months.
4. Prior history of malignancies other than non-Hodgkins lymphoma (except for basal cell
or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
unless the subject has been free of the disease for > or equal to 1 year.
5. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
6. Known positive for HIV.
7. Pregnant or lactating females.
8. Prior > or equal to grade 3 (Appendix III: NCI CTCAE) allergic
reaction/hypersensitivity to thalidomide.
9. Prior > or equal to³ grade 3 (Appendix III: NCI CTCAE) rash or any desquamating
(blistering) rash while taking thalidomide.
10. Prior use of lenalidomide.
11. Use of any standard or experimental anti-cancer drug therapy within 28 days of day 1
of study drug therapy.
12. Known active Hepatitis C.
Locations and Contacts
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
BC Community Oncology Trialist, Burnaby, British Columbia V5H 4K7, Canada
BC Community Oncology, North Vancouver, British Columbia V7L 2P9, Canada
Pacific Coast Hematology/Oncology Medical Group, Onc., Fountain Valley, California 92708, United States
Alta Bates Cancer Center, Berkeley, California 94704, United States
Rush University Medical Center, Chicago, Illinois 60612, United States
Harvard University, Boston, Massachusetts 02115, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
University of Nebraska, Omaha, Nebraska 68198-6805, United States
New York Medical Center, MBCCOP, Bronx, New York 10466, United States
Signal Point Hematology/Oncology, Middletown, Ohio 45042, United States
London Regional Cancer Program, London, Ontario N6A 5W9, Canada
University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada
Swedish Cancer Institute, Seattle, Washington 98104, United States
Gunderson Clinic, Ltd., La Crosse, Wisconsin 54601, United States
Additional Information
Starting date: June 2005
Ending date: November 2006
Last updated: November 30, 2006
|
