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Hodgkin DiseasePhase 2NCT00540007

Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

A Phase 2 study testing Lenalidomide in people with Hodgkin Disease, run by Washington University School of Medicine at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Disease
What is being tested?
Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
5 sitesUnited States
Study dates
6 Sep 2007to 1 Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Ohio State University

    Columbus, Ohio, 43221

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Washington University

    St Louis, Missouri, 63110

  • Wake Forest University Medical School

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Multicenter Study of Lenalidomide in Relapsed or Refractory Classical Hodgkin Lymphoma

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

Read the 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.

Conditions
Hodgkin Disease
Being tested
Lenalidomide
Keywords
Hodgkin Lymphoma, Lenalidomide, Anti-neoplastic agents, Thalidomide
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00540007
Study groupRoleWhat they receive
Cohort 1 - Lenalidomide daily on days 1-21Experimental* 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.
Receives: Drug: Lenalidomide
Cohort 2 - Lenalidomide daily on days 1-28Experimental* 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.
Receives: Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Through 3.5 years from study entry or until disease progression

Secondary outcomes (8)

  1. 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.

    • Adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
    • The higher the grade the worse the adverse event was considered

    Measured: 30 days following the completion of treatment

  2. Cytostatic Overall Response Rate

    • Cytostatic overall response rate = CR + PR + SD greater than or equal to 6 months
    • Definitions per 2007 Cheson Lymphoma Response Criteria

    Measured: From 6 months through 3.5 years after study entry

  3. Participant Response Rate in Relapsed or Refractory cHL.

    -Definitions per 2007 Cheson Lymphoma Response Criteria

    Measured: Through 3.5 years from study entry or until disease progression

  4. Time to Progression (TTP).

    -Time to progression (TTP) is defined as the time from study entry until documented lymphoma progression or death as a result of lymphoma.

    Measured: Through 3.5 years from study entry or until disease progression

  5. Overall Survival (OS)

    Overall survival is defined as the time from entry onto the clinical trial until death as a result of any cause.

    Measured: Through 3.5 years from study entry or until disease progression

  6. Relapse Free Survival (RFS)

    Measured: Through 3.5 years from study entry or until disease progression

  7. Event Free Survival (EFS).

    -Event-free survival (time to treatment failure) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death).

    Measured: Through 3.5 years from study entry or until disease progression

  8. Duration of Response

    -Duration of response: defined as the interval from the date of response (CR or PR) is documented to the date of progression, taking as reference the smallest measurements recorded since the treatment started

    Measured: Through 3.5 years from study entry or until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2007 (estimated)
  2. Study start6 Sep 2007
  3. Primary completion1 Sep 2016
  4. Study completion1 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00540007
Sponsor's protocol ID
07-0233 / 201104227
Status last verified
Oct 2017
First submitted
4 Oct 2007
Last updated
6 Nov 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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. doi: 10.1038/nrc1323. No abstract available.

    PubMed 15057291

  • 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.

    PubMed 21937701

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Hodgkin Disease, run by Washington University School of Medicine at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Overall Response Rate (ORR) in Relapsed or Refractory cHL. (time frame: Through 3.5 years from study entry or until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00540007, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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