Maintenance Lenalidomide in Lymphoma

NCT01575860 | Completed Phase 1 Results DMC

• 1 other identifier: UPCC 11411
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

biopsy-proven diagnosis; completed at least 2 cycles of salvage chemotherapy; showing PET positive residual lesions

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Dose-limiting Toxicities

  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.

  28 days (Cycle 1)

Secondary Outcomes (2)

• Progression Free Survival

  12 months from start of lenalidomide maintenance

• Overall Survival

  12 months from the start of lenalidomide maintenance

Study Arms (1)

Phase I/II (Maintenance Lenalidomide in Lymphoma)

EXPERIMENTAL

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

Interventions

Lenalidomide DRUG

Lenalidomide, 10mg, oral tablets, daily

Also known as: Revlimid, CC-5013

Phase I/II (Maintenance Lenalidomide in Lymphoma)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCREENING STEP A:
• Able to understand and voluntarily sign the informed consent form.
• Aged greater or equal to 18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• 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).
• 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).
• 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):
• Completion of high-dose chemotherapy with ASCT.
• 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).
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• ECOG performance status of less than or equal to 2 at study entry (see Appendix B).
• Patients undergoing planned consolidative radiation therapy must be finished with the therapy by day 100 after ASCT.
• 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.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females (lactating females must agree not to breast feed while taking lenalidomide).
• 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.
• Use of any other experimental drug or therapy within 28 days of initiating treatment with lenalidomide.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum, a blistering or desquamating rash, while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or therapies during study treatment.
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Jakub Svoboda

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The sample size of Phase 1 of Maintenance Lenalidomide in Lymphoma is small. The results need to be confirmed in a larger group of subjects. The trial was prematurely terminated by the Sponsor due to poor accrual. Phase II was not completed.

Results Point of Contact

• Title: Jakub Svoboda, MD. Study Principal Investigator
• Organization: Abramson Cancer Center of the University of Pennsylvania

PennCancerTrials@emergingmed.com

855-216-0098

Study Officials

• Jakub Svoboda, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: May 30, 2018
• Study Completion: October 31, 2022
• Last Updated: March 27, 2023
• Results First Posted: September 4, 2020

Record last verified: 2023-03

Locations

US (1)