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A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)



- Determine the antitumor effectiveness of suberoylanilide hydroxamic acid, as measured
by overall objective response rate, in patients with relapsed diffuse large B-cell


- Determine the duration of response and time to response in patients treated with this

- Determine progression-free survival, time to progression, and 3- and 6-month
progression-free survival rates in patients treated with this drug.

- Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed within 4 weeks and then every
6-12 months thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within
approximately 1 year.

Inclusion Criteria


- Histologically confirmed diffuse large B-cell lymphoma

- De novo or transformed* disease NOTE: *Patients with transformed diffuse large
B-cell lymphoma must meet WHO criteria for diffuse large cell lymphoma on last
biopsy prior to study entry AND have ≥ 1 prior histological diagnosis of
follicular disease

- Relapsed disease, defined as recurrent or progressive disease after standard
first-line chemotherapy (e.g., CHOP or an anthracycline-containing regimen
equivalent) AND 1 systemic salvage therapy that may have included autologous stem
cell transplantation

- Patients who are not candidates for systemic salvage and/or stem cell
transplantation are eligible

- Must have had a response that lasted ≥ 3 months OR stable disease that lasted ≥ 3
months after completion of the most recent treatment

- Failed no more than 3 prior treatment regimens

- Pre-induction chemotherapy and autologous stem cell transplantation are
considered 1 therapy

- Antibody therapy (e.g., rituximab) given in combination with or as consolidation
therapy after a chemotherapy regimen (without intervening relapse) is considered
1 therapy

- Antibody therapy given as a single agent is considered 1 therapy

- Measurable disease, defined as 1 unidimensionally measurable lesion ≥ 2 cm by
conventional CT scan OR ≥ 1 cm by spiral CT scan

- No active brain or leptomeningeal metastases, as indicated by positive cytology from
lumbar puncture or CT scan or MRI

- Previously treated CNS disease allowed provided there is negative cytology from
lumbar puncture

- No known HIV-related malignancy



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3


- Bilirubin < 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver is involved by tumor)

- No active hepatitis B or C infection


- Not specified


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- No acute infection requiring IV antibiotics or antiviral or antifungal agents within
the past 2 weeks

- No ongoing or active infection

- No known HIV positivity

- No known allergy to any component of the study drug

- No acute or chronic graft-vs-host disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-barrier contraception during and for 14
days after completion of study treatment

- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma
in situ of the cervix

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No circumstance that would preclude study participation


Biologic therapy

- See Disease Characteristics

- At least 4 weeks since prior biologic therapy

- No prior allogeneic stem cell transplantation

- No concurrent prophylactic growth factors

- No concurrent anticancer biologic therapy


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- No concurrent anticancer chemotherapy

Endocrine therapy

- Concurrent systemic steroids allowed provided the dosage has been stabilized to the
equivalent of ≤ 10 mg/day of prednisone for ≥ 4 weeks prior to study entry


- At least 4 weeks since prior radiotherapy

- No concurrent anticancer radiotherapy


- At least 4 weeks since prior major surgery

- No prior gastrointestinal resection or procedure that may affect drug absorption


- Recovered from prior therapy

- At least 4 weeks since prior investigational therapy

- No prior histone deacetylase inhibitors (e.g., FR901228, MS-275, or LAQ-824)

- No concurrent vitamins except a single daily multivitamin

- No other concurrent investigational anticancer therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response as assessed by positron emission tomography with fludeoxyglucose (FDG-PET) and the International Workshop Standardized Criteria for Non-Hodgkin's lymphoma

Safety Issue:


Principal Investigator

Sven De Vos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse



Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781