Working… Menu

Maintenance Lenalidomide in Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01575860
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This study is being conducted to evaluate the overall safety of lenalidomide (also known as Revlimid) in patients with lymphoma, and to determine whether it is effective in preventing this disease from returning after stem cell transplant. This study will also determine the dose of lenalidomide that can be given without causing severe side effects. Lenalidomide has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of lymphoma. At least 28 people will be enrolled on this study at the University of Pennsylvania.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Lenalidomide Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Lenalidomide Therapy After Autologous Stem Cell Transplant in Patients With High Risk Relapsed/Refractory Lymphomas
Study Start Date : April 2012
Actual Primary Completion Date : May 30, 2018
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Phase I/II (Maintenance Lenalidomide in Lymphoma)
Total of 24 cycles of lenalidomide. Subjects received a starting daily dose of 10mg lenalidomide on days 1 through 28 of each 28 day cycle. Subjects initiated lenalidomide 28-100 days post-ASCT.
Drug: Lenalidomide
Lenalidomide, 10mg, oral tablets, daily
Other Name: Revlimid, CC-5013

Primary Outcome Measures :
  1. Number of Subjects With Dose-limiting Toxicities [ Time Frame: 28 days (Cycle 1) ]
    Dose-limiting toxicity (DLT) is defined as any grade 3 toxicity or higher that occurs during the first 28 days of therapy and is possibly, probably, or definitely related to lenalidomide maintenance.

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 12 months from start of lenalidomide maintenance ]
    Progression free survival (PFS) is defined as days from start of high dose chemotherapy to first documented progression of disease, death due to any cause or last patient contact.

  2. Overall Survival [ Time Frame: 12 months from the start of lenalidomide maintenance ]
    Overall survival (OS) is defined as days from start of high dose chemotherapy to death due to any cause or last patient contact.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  1. Able to understand and voluntarily sign the informed consent form.
  2. Aged greater or equal to 18 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 diagnosis of lymphoma (including diffuse large B-cell, mantle cell, follicular, marginal zone, peripheral T cell, small lymphocytic lymphoma with large cell transformation, and Hodgkin lymphomas).
  5. Completion of at least 2 cycles of salvage chemotherapy, with pre-ASCT PET/CT imaging showing PET positive residual lesion(s) (SUV greater than 2.5).
  6. Disease free of other malignancies for greater or equal to 2 years with exception of basal cell and squamous cell carcinomas of the skin, or carcinoma in situ of the cervix or breast.

NOTE: Patients who successfully complete high dose-chemotherapy and ASCT will proceed to Screening Step B, provided that they achieve hematologic recovery within 100 days of ASCT (see below).

SCREENING STEP B (performed between days 28-100 post-ASCT):

  1. Completion of high-dose chemotherapy with ASCT.
  2. Hematologic recovery at 28-100 days after ASCT (defined as ANC greater or equal to 1,000 and platelet count greater or equal to 60,000).
  3. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  4. ECOG performance status of less than or equal to 2 at study entry (see Appendix B).
  5. Patients undergoing planned consolidative radiation therapy must be finished with the therapy by day 100 after ASCT.
  6. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  7. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (warfarin or low molecular weight heparin may be used for patients intolerant of aspirin or at the discretion of the treating physician).

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).
  3. 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.
  4. Use of any other experimental drug or therapy within 28 days of initiating treatment with lenalidomide.
  5. Known hypersensitivity to thalidomide.
  6. The development of erythema nodosum, a blistering or desquamating rash, while taking thalidomide or similar drugs.
  7. Any prior use of lenalidomide.
  8. Concurrent use of other anti-cancer agents or therapies during study treatment.
  9. Known seropositive for or active viral infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01575860

Layout table for location information
United States, Pennsylvania
Jakub Svoboda
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Layout table for investigator information
Principal Investigator: Jakub Svoboda, MD Abramson Cancer Center of the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Abramson Cancer Center of the University of Pennsylvania:
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01575860    
Other Study ID Numbers: UPCC 11411
First Posted: April 12, 2012    Key Record Dates
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020
Last Verified: July 2020
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
biopsy-proven diagnosis
completed at least 2 cycles of salvage chemotherapy
showing PET positive residual lesions
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents