Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma - Full Text View

Sponsors and Collaborators:	Washington University School of Medicine Celgene Corporation
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00540007

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 Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of lenalidomide therapy in relapsed or refractory cHL. [ Time Frame: Length of study ] [ 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 ] [ Designated as safety issue: No ]
To assess time to progression (TTP). [ Time Frame: Length of study ] [ Designated as safety issue: No ]
To assess overall survival (OS) and event free survival (EFS). [ Time Frame: Length of study ] [ Designated as safety issue: No ]
To assess relapse free survival (RFS) and duration of response. [ Time Frame: Length of study ] [ 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 ]

Estimated Enrollment:	70
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental lenalidomide po, Days 1 thru 21 of a 28 day cycle	Drug: Lenalidomide Lenalidomide 25 mg/day po on days 1-21 of a 28 day cycle.
2: Experimental lenalidomide po, Days 1 thru 28 of a 28 day cycle	Drug: lenalidomide Lenalidomide 25 mg/day po on days 1-28 of a 28 day cycle.

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 (see Appendix 1).
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.
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.
FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug.
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540007

Contacts

Contact: Todd Fehniger, M.D., Ph.D.

314-747-1385

tfehnige@dom.wustl.edu

Locations

United States, Missouri
Washington University	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Todd Fehniger, M.D.,Ph.D. 314-747-1385 tfehnige@dom.wustl.edu
Principal Investigator: Todd Fehniger, M.D., Ph.D.
Sub-Investigator: Nancy Bartlett, M.D.
United States, New Jersey
Hackensack University Medical Center	Active, not recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Wake Forest University Medical School	Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University	Active, not recruiting
Columbus, Ohio, United States, 43221
United States, Wisconsin
Medical College of Wisconsin	Active, not recruiting
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:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. Review. No abstract available.

Responsible Party:	Washington University ( Todd Fehniger, M.D., Ph.D. )
Study ID Numbers:	07-0233
Study First Received:	October 4, 2007
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00540007 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

Hodgkin Lymphoma
Lenalidomide
Anti-neoplastic agents
Thalidomide

Study placed in the following topic categories:

Anti-Infective Agents
Immunoproliferative Disorders
Thalidomide
Immunologic Factors
Hodgkin Lymphoma, Adult
Lenalidomide
Hodgkin's Disease

Angiogenesis Inhibitors
Immunosuppressive Agents
Lymphatic Diseases
Anti-Bacterial Agents
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Thalidomide
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Lenalidomide
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Leprostatic Agents

ClinicalTrials.gov processed this record on August 28, 2009