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A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies

Phase 2
3 Years
Not Enrolling
EBV Lymphomas, Lympho-proliferative Diseases

Thank you

Trial Information

A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies

Inclusion Criteria:

- Age ≥ 3 years. (No dosing or adverse event data are currently available on the use
of valganciclovir in patients < 16 years of age.)

- Life expectancy of > 3 months.

- ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%.

- Baseline (untransfused) HbF level > 2%

- Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥
1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit
of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal.
(v) creatinine within normal range for institution.

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.

- Able and willing to give informed consent.

Exclusion Criteria:

- Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form
adverse events due to agents administered 4 weeks earlier.

- Patients may not be receiving any other investigational agents.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Arginine Butyrate, ganciclovir or valganciclovir.

- Patients who have an acute myocardial infarction or onset of atrial fibrillation
within the past 6 months.

- Uncontrolled intercurrent illness including, but not limited to , ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Tumor impinging on an organ or anatomical structure deemed critical by the

- Pregnant women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)

Outcome Time Frame:

Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)

Safety Issue:


Principal Investigator

Adam Lerner, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University School of Mediciine


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • EBV Lymphomas
  • Lympho-proliferative Diseases
  • Lymphoma
  • Lymphoproliferative Disorders



Hackensack University Medical Center Hackensack, New Jersey  07601