A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin’s Lymphoma

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Brief Title

A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma

Official Title

A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma

Brief Summary

      T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with
      chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively
      uncommon and therefore not well studied. Treatment approaches are patterned after the more
      common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard
      therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this
      study, we will administer the drug called lenalidomide as a pill to patients with T-cell
      lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to
      determine if the treatment is well tolerated in this patient group. This study will take
      place at six cancer centres across Canada.
    

Detailed Description

      Background: T-cell lymphomas comprise 10-15% of all non-Hodgkin's lymphomas and include a
      variety of histological subtypes. These diseases have variable clinical behaviour, response
      to therapy, and long-term outcomes. In general, T-cell lymphomas are characterized by
      inferior response to therapy and prognosis compared to the more common B-cell lymphomas.
      Because T-cell lymphomas are uncommon, they are not generally well studied and current
      treatment approaches are borrowed from established protocols for B-cell lymphoma. New
      therapies are needed for T-cell lymphoma, and should be studied separately for their
      effectiveness in T-cell lymphoma.

      Lenalidomide (CC-5013, Revlimid; Celgene Corporation) is an oral thalidomide analogue with
      anti-cancer activity. Lenalidomide is generally well tolerated, with rash, myelosuppression
      and venous thrombosis being the most notable and common potential side effects. Lenalidomide
      has demonstrated impressive anti-cancer activity against mycosis fungoides (cutaneous T-cell
      lymphoma), multiple myeloma, chronic lymphocytic leukemia and myelodysplasia. The drug is
      currently under review by Health Canada as a potential new standard therapy for multiple
      myeloma. We are encouraged by the efficacy and tolerability of lenalidomide in patients with
      related diseases, to study its role in the treatment of T-cell lymphomas other than mycosis
      fungoides.

      Primary Objective: To determine the overall response rate to single agent lenalidomide at
      standard doses (25 mg po daily for 21 days of a 28-day cycle), as a treatment for T-cell
      lymphoma.

      Secondary Objectives: To determine the complete response rate, time to progression, overall
      survival and tolerability for patients with T-cell lymphoma treated with lenalidomide.

      Study Design: A multi-centre, Canadian, Phase II, investigator-initiated clinical trial.

      Inclusion Criteria:

      " Patients with the following subtypes of T-cell lymphoma:

        -  Peripheral T-cell lymphoma, unspecified

        -  Angioimmunoblastic T-cell lymphoma

        -  Enteropathy-type T-cell lymphoma

        -  NK/T-cell lymphoma

        -  Hepatosplenic T-cell lymphoma

        -  Subcutaneous panniculitic-like T-cell lymphoma

        -  Anaplastic large cell lymphoma

        -  Lymphoblastic T-cell lymphoma " Measurable disease (See section 6.2) " WHO performance
           status of 0-2 " Both untreated patients with contraindications to chemotherapy, and
           patients with relapsed/refractory disease after at least one line of chemotherapy are
           allowed; no restriction on the number of prior therapies " Patients with prior
           radiotherapy, autologous or allogeneic stem cell transplant are allowed " Age >18 years,
           able to give informed consent " Acceptable hematological and biochemical parameters (see
           section 6.2)

      Exclusion Criteria:

      " Mycosis Fungoides/Sezary Syndrome " Pregnant or lactating females " Concurrent use of other
      anti-cancer therapies " Other serious co-morbid illness that would compromise participation
      in the study " Prior therapy with lenalidomide " Prior hypersensitivity to thalidomide

      It is intended to enroll patients who have relapsed in spite of chemotherapy, radiotherapy
      and/or high dose therapy with stem cell transplant, or patients who are not eligible for
      these standard therapies. It would be encouraged that patients are initially treated with
      standard therapy if possible. However, we wish to allow untreated patients to participate
      because older, frail patients with disseminated T-cell lymphoma or patients with significant
      comorbidities may not be eligible for aggressive chemotherapy but may tolerate lenalidomide
      quite well. In this regard, it is left to the discretion of the investigator to determine
      whether or not an individual patient should be considered for enrollment on this clinical
      trial, or whether that patient would be better served with standard treatment approaches.

      Recruitment will take place in the outpatient clinics of the Cross Cancer Institute and five
      other Canadian cancer clinics (Vancouver, Calgary, Winnipeg, Ottawa, Halifax). The Cross
      Cancer Institute will be the lead site for the trial and our team will be responsible for
      oversight of the trial, collation of patient case report forms, communication with Health
      Canada and Celgene, and data analysis. Celgene will monitor all the sites involved in the
      trial every 3-4 months.

      Statistical Analysis will use standard methods and will include a data safety and monitoring
      committee (DSMB) who will perform interim safety analyses after ten and 22 patients have been
      enrolled on trial. An interim efficacy analysis will be performed after 22 patients have been
      enrolled. The trial will be stopped if fewer than 2 of the first 22 patients enrolled achieve
      an objective response to therapy according to standard criteria. If two or more responses
      occur, the trial will continue until the remaining 18 patients will be accrued in the absence
      of safety concerns. There are no pre-specified criteria for stopping the trial on the basis
      of safety concerns, but the investigators and the independent DSMB will each have the power
      to halt enrollment if serious safety concerns arise at any point during the trial. Patients
      will be required to stop the study treatment if severe adverse reactions occur, the lymphoma
      progresses, serious intercurrent illness interferes with treatment, suspected pregnancy
      occurs, or for major study protocol violations.

      Sample size: For a total of 40 subjects, 22 will be accrued during stage 1 and 18 during
      stage 2. If 1 or fewer responses are observed during the first stage then the trial is
      stopped early. Given that the 'true' response probability is 5%, there is a 70% probability
      of ending the trial during stage 1. However, if the 'true' response probability is 20% then
      there is a 5% probability that the trial will be stopped in stage 1. The alpha level of the
      design is 0.04 and the power is 0.9. If fewer than 4 of 40 patients respond, this will be
      considered evidence that lenalidomide is inactive in the population studied.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

overall response rate

Secondary Outcome

 complete response rate

Condition

T-cell Lymphoma

Intervention

Lenalidomide


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

June 2006

Completion Date

July 2014

Primary Completion Date

May 2014

Eligibility Criteria

        Inclusion Criteria:

          -  T-cell lymphoma (excluding mycosis fungoides)

          -  WHO performance status 0-2

          -  measurable lesions

          -  acceptable hematological and biochemical parameters

          -  previously treated OR untreated but not suitable for standard therapy

        Exclusion Criteria:

          -  pregnant

          -  HIV

          -  viral hepatitis
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tony Reiman, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00322985

Organization ID

22409


Responsible Party

Sponsor

Study Sponsor

AHS Cancer Control Alberta

Collaborators

 Celgene Corporation

Study Sponsor

Tony Reiman, MD, Principal Investigator, Alberta Health Services


Verification Date

March 2016