Maintenance Lenalidomide in Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01575860
First received: April 10, 2012
Last updated: May 8, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Lymphoma
Drug: Lenalidomide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Maintenance Lenalidomide in Lymphoma

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCREENING STEP A:

  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575860

Contacts
Contact: Amanda Gordon 215-662-6392 amanda.gordon@uphs.upenn.edu

Locations
United States, Pennsylvania
Jakub Svoboda Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Jakub Svoboda, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Jakub Svoboda, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01575860     History of Changes
Other Study ID Numbers: UPCC 11411
Study First Received: April 10, 2012
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

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:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014