Lenalidomide Maintenance Therapy Post Autologous Transplant for Hodgkins Lymphoma

March 9, 2021 updated by: Washington University School of Medicine

A Pilot Study of Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Hodgkin Lymphoma

The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

-To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous stem cell transplant, as measured by dropout rate.

Secondary Objectives

  • To assess overall survival, event free survival, and progression free survival.
  • To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
  • To assess the conversion of partial response/stable disease post-ASCT to complete response.
  • To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Wake Forest University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy.

  • Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. If the original diagnostic specimen is not available, relapsed or refractory specimens may be used. Bone marrow biopsies as the sole means of diagnosis are not acceptable; however, they may be used in conjunction with nodal biopsies. Fine needle aspirates (FNA) are not acceptable. Pathology reports must be submitted with the appropriate CRFs, and the actual biopsy specimens are not requested for central review. Patients with cHL have one of the following WHO subtypes:

    • Nodular sclerosis Hodgkin lymphoma
    • Lymphocyte-rich Hodgkin lymphoma
    • Mixed cellularity Hodgkin lymphoma
    • Lymphocyte-deplete Hodgkin lymphoma cHL patients without one of these subtypes designated cHL not otherwise specified are also eligible.

NOTE: Patients with nodular lymphocyte-predominant HL are not eligible.

  • Patient must have undergone autologous stem cell transplant (ASCT) between 60 and 90 days prior to study registration.
  • Patient must be ≥ 18 years old.
  • Patient must have an ECOG performance status of ≤ 2 at study entry.

  • Patient must have adequate hematologic, renal, and hepatic function as defined by:

    • Absolute neutrophil count ≥ 1000 / μL
    • Platelets ≥ 30,000 / μL
    • Serum creatinine ≤ 1.5 X institution upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) ≤ 3 x ULN (if not attributed to cHL)
  • Patient must be disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Patient must understand and voluntarily sign an informed consent form.
  • Patient must be able to adhere to the study visit schedule and other protocol requirements.
  • If a female of childbearing potential (FCBP), patient 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
  • A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • A FCBP must have two negative 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 the study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
  • If male, patient must agree to use a latex condom during sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
  • Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
  • Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.

Exclusion Criteria:

  • Patient who has undergone allogeneic stem cell transplantation.
  • Patient who shows evidence of progressive disease during salvage chemotherapy or following ASCT.
  • Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form.
  • Patient has any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Patient has used any other anti-cancer drug or therapy, including experimental, within 30 days of initiation of lenalidomide treatment (radiation therapy is allowed within 30 days).
  • Patient has known hypersensitivity to thalidomide.
  • Patient developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Patient has any prior use of lenalidomide.
  • Patient is known to be positive for HIV or infectious hepatitis, type A, B, or C.
  • Patient is pregnant or breastfeeding.
  • Patient has concurrent use of other anti-cancer agents or treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1

Lenalidomide 15 mg/day Cycle 1 (28 days).

If no unacceptable side effects Cycle 2 (28 days) will be lenalidomide 20 mg/day.

If no unacceptable side effects Cycles 3 thru 18 (28 days for each cycle) will be lenalidomide 25 mg/day.
Drug: Lenalidomide
Other Names:
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate.
Time Frame: 12 months
Will be described by the proportion of patients who drop out of the study for drug-related reasons at or before 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Until death (estimated to be 10 years)
Until death (estimated to be 10 years)
Adverse event profile
Time Frame: From start of treatment through 30 days following completion of treatment
To establish the adverse event profile of long-term maintenance therapy with lenalidomide in this patient population.
From start of treatment through 30 days following completion of treatment
Conversion of partial response/stable disease post-ASCT to complete response.
Time Frame: 1 year
To assess the conversion of partial response/stable disease post-autologous stem cell transplant to complete response.
1 year
Evaluate immune response
Time Frame: Through 30 days after end of treatment
To evaluate changes in immune cell number and function and plasma proteins before, during, and after lenalidomide therapy (correlative studies).
Through 30 days after end of treatment
Event-free survival (EFS)
Time Frame: Until progression or death (whichever comes first) - estimated to be 10 years
Until progression or death (whichever comes first) - estimated to be 10 years
Progression-free survival (PFS)
Time Frame: Until progression (estimated to be 10 years)
Until progression (estimated to be 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Todd Fehniger, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2011

Primary Completion (Actual)

September 19, 2016

Study Completion (Actual)

March 5, 2021

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201010719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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