Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

NCT00540007 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 07-0233 / 201104227
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hodgkin Disease

Keywords

Hodgkin Lymphoma; Lenalidomide; Anti-neoplastic agents; Thalidomide

Outcome Measures

Primary Outcomes (1)

• Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL.

  * Overall response rate = CR + PR * Definitions per 2007 Cheson Lymphoma Response Criteria

  Through 3.5 years from study entry or until disease progression

Secondary Outcomes (8)

• Safety and Tolerability of Lenalidomide Therapy as Measured by the Number of Participants Who Experience Each Adverse Event (Grade 3 or 4 Adverse Events Only) Refractory cHL.

  30 days following the completion of treatment

• Cytostatic Overall Response Rate

  From 6 months through 3.5 years after study entry

• Participant Response Rate in Relapsed or Refractory cHL.

  Through 3.5 years from study entry or until disease progression

• Time to Progression (TTP).

  Through 3.5 years from study entry or until disease progression

• Overall Survival (OS)

  Through 3.5 years from study entry or until disease progression

Study Arms (2)

Cohort 1 - Lenalidomide daily on days 1-21

EXPERIMENTAL

* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 * Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle.

Drug: Lenalidomide

Cohort 2 - Lenalidomide daily on days 1-28

EXPERIMENTAL

* The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2 * Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Also known as: Revlimid, CC-5013

Cohort 1 - Lenalidomide daily on days 1-21; Cohort 2 - Lenalidomide daily on days 1-28

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celgene Corporation: collaborator

Study Sites (5)

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Wake Forest University Medical School

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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. doi: 10.1038/nrc1323. No abstract available.

  PMID: 15057291 BACKGROUND

• Fehniger TA, Larson S, Trinkaus K, Siegel MJ, Cashen AF, Blum KA, Fenske TS, Hurd DD, Goy A, Schneider SE, Keppel CR, Wagner-Johnston ND, Carson KR, Bartlett NL. A phase 2 multicenter study of lenalidomide in relapsed or refractory classical Hodgkin lymphoma. Blood. 2011 Nov 10;118(19):5119-25. doi: 10.1182/blood-2011-07-362475. Epub 2011 Sep 21.

  PMID: 21937701 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; 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

Results Point of Contact

• Title: Todd Fehniger, M.D., Ph.D.
• Organization: Washington University School of Medicine

tfehnige@wustl.edu

314-747-1385

Study Officials

• Todd Fehniger, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: September 6, 2007
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 6, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)