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A Phase I Study of the Combination of Lenalidomide With the Histone Deacetylase Inhibitor, Vorinostat in Hodgkin and Non Hodgkin's Lymphoma

Phase 1
18 Years
Not Enrolling
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Peripheral T-Cell Lymphoma, Post-transplant Lymphoproliferative Disorder, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Testicular Lymphoma, Waldenstrom Macroglobulinemia

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Trial Information

A Phase I Study of the Combination of Lenalidomide With the Histone Deacetylase Inhibitor, Vorinostat in Hodgkin and Non Hodgkin's Lymphoma


I. To assess the safety and tolerability of the combination of lenalidomide and vorinostat.

II. To determine the maximum tolerated dose (MTD) and recommended dose of vorinostat and
lenalidomide when given in combination in this patient population.


I. To obtain preliminary data for response rate, time to response, response duration and
time to progression (TTP) for vorinostat and lenalidomide when used in combination.

OUTLINE: This is a dose-escalation study of vorinostat.

Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily
on days 1-21. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- Patients must have a history of biopsy-documented Hodgkin or non-Hodgkin lymphoma
(either B or T cell) and with relapsed or refractory disease after at least one prior
line of therapy

- All previous cancer therapy, including radiation, hormonal therapy and surgery, must
have been discontinued at least 4 weeks prior to treatment in this study

- Patients must have measurable disease by CT scan; PET scans are desirable but not
mandatory, so that patients with negative PET scans but measurable disease by CT are

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study

- Patients may be enrolled who relapse after autologous stem cell transplant or after
allogeneic transplant; they must have no active related infections (i.e., fungal or
viral), no acute graft versus host disease (GvHD) of any grade, and no chronic GvHD
other than mild skin, or, or ocular GvHD not requiring systemic immunosuppression

- Laboratory test results within these ranges:

- Absolute neutrophil count >= 1,000/mm^3

- Platelet count >= 75,000/mm^3

- Serum creatinine =< 1.5 mg/dL

- Total bilirubin <= 1.5 mg/dL (however, patients with elevation of unconjugated
bilirubin alone, as in Gilbert's disease, are eligible)

- AST (SGOT) =< 2 x upper limit of normal (ULN)

- ALT (SGPT) =< 2 x ULN

- Disease free of prior malignancies for >= 5 years with exception of currently treated
blast cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

- All study participants must be registered into the mandatory RevAssist program and be
willing and able to comply with the requirements of RevAssist

- Females of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/ml within 10-14 days prior to
and again within 24 hours of prescribing lenalidomide (prescriptions must be filled
within 7 days) 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 she
starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men
must agree to use a latex condom during sexual contact with a FCBP even if they have
had a successful vasectomy

- Able to take aspirin or low molecular weight heparin as prophylactic anticoagulation

- Life expectancy greater than 3 months

- Able to swallow enteral medications


- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or breast-feeding females; lactating females must agree not to breastfeed
while taking lenalidomide

- Any condition, including the presence of laboratory abnormalities, that places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study

- Use of any other experimental drug or therapy with 28 days of baseline

- Known sensitivity to thalidomide or histone deacetylating agents

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Any prior use of lenalidomide, vorinostat, or other histone deacetylase inhibitors
other than valproic acid, which must be stopped 2 weeks prior to study unless being
used for seizure control

- Concurrent use of other anti-cancer agents or treatments

- Known positive for HIV or infectious hepatitis type B or C

- Patients with known brain/CNS metastases

- Patients with feeding tubes

- Any history of deep vein thrombosis (DVT) or pulmonary embolism (PE)

- Any current infection requiring the use of antibiotic, antiviral, or antifungal

- Any uncontrolled dysrhythmias

- Baseline QTcF interval > 500 msec in the absence of correctable electrolyte imbalance
or any patient with a congenital history of QTc prolongation

- Current therapeutic anti-coagulation

- Any contraindication to safely using prophylactic anticoagulation

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population

Outcome Time Frame:

Following Cycle 1 of treatment

Safety Issue:


Principal Investigator

Leslie Popplewell

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2010

Completion Date:

August 2010

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Hepatosplenic T-cell Lymphoma
  • Intraocular Lymphoma
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Post-transplant Lymphoproliferative Disorder
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Grade III Lymphomatoid Granulomatosis
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Recurrent Small Lymphocytic Lymphoma
  • Small Intestine Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Testicular Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Hodgkin Disease
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Lymphoproliferative Disorders
  • Waldenstrom Macroglobulinemia
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell



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