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Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL

Phase 2
18 Years
Open (Enrolling)
Leukemia, Lymphoma

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Trial Information

Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL


- 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

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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to therapy (complete response, partial response, or stable disease)

Safety Issue:


Principal Investigator

Fernando Cabanillas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Auxilio Mutuo Cancer Center



Study ID:




Start Date:

August 2009

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Waldenstrom macroglobulinemia
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin