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

Phase 0
18 Years
Open (Enrolling)
Hodgkin Disease

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Trial Information

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

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

- To evaluate changes in immune cell number and function and plasma proteins before,
during, and after lenalidomide therapy (correlative studies).

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

- 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

- 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

- Patient must be registered into the mandatory RevAssist® program and be willing and
able to comply with the requirements of RevAssist®.

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.

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after ASCT, as measured by dropout rate.

Outcome Description:

Will be described by the proportion of patients who drop out of the study for drug-related reasons at or before 12 months

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Todd Fehniger, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2011

Completion Date:

June 2016

Related Keywords:

  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma



Washington University School of MedicineSaint Louis, Missouri  63110
Ohio State UniversityColumbus, Ohio  43210