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Trial record 36 of 42 for:    LENALIDOMIDE AND Leukemia AND SLL

Vorinostat and Lenalidomide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116154
Recruitment Status : Terminated (Sponsor withdrew support for the study)
First Posted : May 4, 2010
Last Update Posted : December 9, 2010
Information provided by:
City of Hope Medical Center

Brief Summary:

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vorinostat together with lenalidomide may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide in treating patients with relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
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 Drug: lenalidomide Drug: vorinostat Other: laboratory biomarker analysis Phase 1

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Combination of Lenalidomide With the Histone Deacetylase Inhibitor, Vorinostat in Hodgkin and Non Hodgkin's Lymphoma
Study Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Arm I
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.
Drug: lenalidomide
Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid

Drug: vorinostat
Given orally
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Assessment of the Maximum Tolerated Dose and Dose-Limiting Toxicities of the combination of vorinostat and lenalidomide in this patient population [ Time Frame: Following Cycle 1 of treatment ]

Secondary Outcome Measures :
  1. Number of patients with Grade 3 or above adverse events [ Time Frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug ]
  2. Duration, intensity, and time to onset of toxicities [ Time Frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug ]
  3. AE, laboratory safety assessments, ECOG, ECGs, vital signs, transfusions, hospital days, and antibiotic use [ Time Frame: Day 8 and 22 of Cycle 1 and Day 1 of subsequent cycles and Day 30 following the last dose of study drug ]
  4. Objective response rate [ Time Frame: Every nine weeks on therapy after 2 years a minimum of every 6 months ]
  5. Time to response [ Time Frame: Every nine weeks on therapy after 2 years a minimum of every 6 months ]
  6. Response duration [ Time Frame: Every nine weeks on therapy after 2 years a minimum of every 6 months ]
  7. Progression-free survival [ Time Frame: Every nine weeks on therapy after 2 years a minimum of every 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study entry
  • 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 medication
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116154

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United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
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Principal Investigator: Leslie Popplewell City of Hope Medical Center

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Responsible Party: Popplewell, Leslie, City of Hope Identifier: NCT01116154     History of Changes
Other Study ID Numbers: 08144
NCI-2010-00947 ( Registry Identifier: NCI CTRP )
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Burkitt Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hodgkin Disease
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Waldenstrom Macroglobulinemia
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Lymphomatoid Granulomatosis
Lymphoma, Extranodal NK-T-Cell
Intraocular Lymphoma