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Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia

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: NCT01016990
Recruitment Status : Unknown
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 20, 2009
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also help cancer cells become more like normal cells, and grow and spread more slowly.

PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Drug: valproic acid Genetic: western blotting Other: laboratory biomarker analysis Other: pharmacological study Phase 2

Detailed Description:


  • To determine if valproic acid has a response rate of ≥ 20% in patients with previously treated relapsed or refractory non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia.
  • To determine if treatment with valproic acid leads to measurable levels of histone acetylation in peripheral blood.

OUTLINE: Patients are stratified according to disease diagnosis (indolent non-Hodgkin lymphoma [NHL] vs. aggressive NHL and Hodgkin lymphoma). Valproic acid doses are adjusted until therapeutic level is achieved.

Patients receive oral valproic acid daily for 3 weeks. Treatment repeats every 3 weeks for at least 2 courses and up to 2 years in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically. Samples are analyzed for valproic acid levels; and hyperacetylation (caused by the valproic acid N-terminals of the histones H3 and H4) via western blot.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
Study Start Date : August 2009
Estimated Primary Completion Date : September 2011

Primary Outcome Measures :
  1. Response to therapy (complete response, partial response, or stable disease)

Secondary Outcome Measures :
  1. Length of response
  2. Time to treatment failure
  3. Survival duration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Diagnosis of relapsed or refractory Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), or chronic lymphocytic leukemia (CLL )
  • Patient must have evaluable or measurable disease
  • Have failed prior treatment, as evidenced by 1 of the following:

    • Aggressive NHL

      • Failed at least 1 regimen containing rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) (unless anthracyclines are contraindicated) in addition to another salvage regimen (unless it is determined by the treating physician that it is to the patient's best interest to receive valproic acid after the first relapse)
    • Hodgkin lymphoma

      • Failed ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and received salvage chemotherapy with at least 1 salvage combination regimen
    • Indolent or low-grade lymphoma

      • Failed at least 1 combination regimen containing rituximab (patients who are intolerant to the available therapies or have contraindications for them are eligible for the study)
  • No CNS involvement by lymphoma


  • ECOG performance status 0-2
  • Absolute granulocyte count ≥ 1,000/mm^3
  • Platelet count ≥ 50,000/µL
  • AST and ALT ≤ 3 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


  • More than 14 days since prior anticancer treatment
  • Prior high-dose chemotherapy with transplant allowed
  • No prior valproic acid
  • No concurrent corticosteroids

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): NCT01016990

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Puerto Rico
Centro de Cancer del Hospital Auxilio Mutuo Recruiting
San Juan, Puerto Rico, 00936-2712
Contact: Contact Person    787-771-7933      
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
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Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center
Layout table for additonal information Identifier: NCT01016990    
Other Study ID Numbers: CDR0000659192
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: November 2009
Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
refractory chronic lymphocytic leukemia
recurrent cutaneous T-cell non-Hodgkin lymphoma
peripheral T-cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
Waldenström macroglobulinemia
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs