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Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00540007
First received: October 4, 2007
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to determine the efficacy of lenalidomide in the treatment of relapsed or refractory classic Hodgkin lymphoma(cHL).


Condition Intervention Phase
Hodgkin Disease
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To assess the overall response rate (RR) in relapsed or refractory cHL. [ Time Frame: After cycles 2, 4, 6, 9, 12, and then every 3 cycles. Follow-up every 6 months for 2 years, then annually for a maximum of 3.5 years from study entry or until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of lenalidomide therapy in relapsed or refractory cHL. [ Time Frame: 30 days following the completion of treatment ] [ Designated as safety issue: Yes ]
  • To assess the complete response rate (CR), partial response (PR) and stable disease (SD) rate in relapsed or refractory cHL. [ Time Frame: After cycles 2, 4, 6, 9, 12, and then every 3 cycles. Follow-up every 6 months for 2 years, then annually for a maximum of 3.5 years from study entry or until disease progression ] [ Designated as safety issue: No ]
  • To assess time to progression (TTP). [ Time Frame: After cycles 2, 4, 6, 9, 12, and then every 3 cycles. Follow-up every 6 months for 2 years, then annually for a maximum of 3.5 years from study entry or until disease progression ] [ Designated as safety issue: No ]
  • To assess overall survival (OS) [ Time Frame: Follow-up through 3.5 years from study entry ] [ Designated as safety issue: No ]
  • To assess relapse free survival (RFS) [ Time Frame: Follow-up through 3.5 years from study entry ] [ Designated as safety issue: No ]
  • To evaluate changes in NK cell number and function, plasma cytokines, gene expression profiles of peripheral blood, and plasma proteins via proteomics, before, during, and after lenalidomide therapy (correlative studies). [ Time Frame: pre-therapy, day 15 of cycle 1, day 1 of cycles 2, 4, 6, 12, and then Q 6 cycles, and at 30 and 60 days post-therapy ] [ Designated as safety issue: No ]
  • To assess event free survival (EFS). [ Time Frame: Follow up through 3.5 years from study entry ] [ Designated as safety issue: No ]
  • To assess duration of response. [ Time Frame: After cycles 2, 4, 6, 9, 12, and then every 3 cycles. Follow-up every 6 months for 2 years, then annually for a maximum of 3.5 years from study entry or until disease progression ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.
Drug: Lenalidomide
Other Names:
  • Revlimid
  • CC-5013
Experimental: Cohort 2
Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Drug: Lenalidomide
Other Names:
  • Revlimid
  • CC-5013

Detailed Description:

Hodgkin lymphoma (HL), an uncommon but significant subtype of lymphoma, is divided into classical HL (cHL) and nodular lymphocyte predominant HL (NLPHL). Progress has been made in cHL therapy resulting in 5-year failure free survival rates between 61%-89% even in the setting of advanced stage or bulky disease. Patients who relapse however, have a variable prognosis ranging from a 8-year overall survival rate of less than 8% for patients who never achieve a remission to 54% for patients with a complete remission lasting greater than 12 months. High dose chemotherapy with autologous stem cell support is the standard of care for patients with relapsed cHL but for those that relapse despite aggressive salvage therapy 20 - 50%, with median remission durations of approximately 6 months. Furthermore, a subset of relapsed HL patients may not be candidates for aggressive salvage regimens. These novel salvage therapies are needed for relapsed/refractory cHL, especially agents without serious late toxicities are particularly attractive in this disease. Advances in the understanding of HL pathogenesis and lenalidomide's mechanisms of action provide substantial rationale for evaluating lenalidomide in HL patients.

  Eligibility

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

Inclusion Criteria:

  • Histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy.
  • Patients must have relapsed or progressed after at least one prior systemic cytotoxic chemotherapy; prior autologous or allogeneic stem cell transplantation is allowed.
  • Measurable disease must be present either on physical examination or imaging studies (CT, MRI, PET/CT). Any tumor mass greater or equal to 1 cm is acceptable.
  • Age > 18 years old.
  • ECOG performance status of less than or equal to 2 at study entry
  • Adequate hematologic, renal, hepatic function as defined by:

    • Absolute neutrophil count greater than or equal to 1000 / uL
    • Platelets greater than or equal to 50,000 / uL
    • Serum creatinine less than or equal to 1.5X institution upper limit of normal (ULN)
    • Total bilirubin less than or equal to 2.0 mg/dL
    • AST (SGOT) and ALT (SGPT) less than or equal to 3 x ULN (if not attributed to cHL)
  • Disease free of prior malignancies for greater than or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Understand and voluntarily sign an informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements
  • Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
  • FCBP must have two negative serum or urine pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) 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. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
  • Men must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
  • All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight
  • All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.

Exclusion Criteria:

  • Patients who are candidates for high dose chemotherapy and stem cell transplantation and have not yet undergone stem cell transplantation should not be enrolled.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Any condition, including the presence of laboratory abnormalities.
  • Use of any other anti-cancer drug or therapy, including experimental, within 30 days of enrollment.
  • Known hypersensitivity to thalidomide.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Any prior use of lenalidomide.
  • Known positive for HIV or infectious hepatitis, type A, B or C.
  • Pregnant or breastfeeding females.
  • Concurrent use of other anti-cancer agents or treatments.
  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: NCT00540007

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Wake Forest University Medical School
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Washington University School of Medicine
Celgene Corporation
Investigators
Principal Investigator: Todd Fehniger, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00540007     History of Changes
Other Study ID Numbers: 07-0233 / 201104227
Study First Received: October 4, 2007
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Hodgkin Lymphoma
Lenalidomide
Anti-neoplastic agents
Thalidomide

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014