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Phase I/II Study of Vorinostat (SAHA), Cladribine, and Rituximab (SCR) in Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, and Relapsed B Cell Non-Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

Phase I/II Study of Vorinostat (SAHA), Cladribine, and Rituximab (SCR) in Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, and Relapsed B Cell Non-Hodgkin's Lymphoma


OBJECTIVES:

Primary

- To determine the maximum tolerated dose of vorinostat when administered in combination
with cladribine and rituximab in patients with mantle cell lymphoma, chronic
lymphocytic leukemia (CLL), or relapsed B-cell non-Hodgkin lymphoma (NHL).

Secondary

- To determine the response rate in patients treated with this regimen.

- To determine the safety and efficacy of this regimen in these patients.

- To determine the progression-free survival of patients treated with this regimen.

- To determine the overall survival of patients treated with this regimen.

- To collect blood samples for genetic testing to help understand how NHL and CLL are
affected by vorinostat alone and by vorinostat in combination with cladribine and
rituximab.

OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II
study.

- Phase I: Patients receive oral vorinostat on days 1-14 and cladribine on days 1-5.
Patients also receive rituximab on days 3, 10, 17, and 24 of course 1 and on day 3 of
all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

- Phase II: Patients receive vorinostat (at the maximum tolerated dose determined in
phase I), cladribine, and rituximab as in phase I.

Blood samples are collected periodically for laboratory studies.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of the following B-cell malignancies:

- Chronic lymphocytic leukemia (CLL)

- Non-Hodgkin lymphoma (NHL), including mantle cell lymphoma

- Newly diagnosed or relapsed/refractory disease

- Patients enrolled in phase I must have relapsed or refractory disease

- Patients enrolled in phase II who have NHL (excluding mantle cell lymphoma) must
have relapsed or refractory disease

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of vorinostat

Outcome Time Frame:

Daily on days 1-14

Safety Issue:

Yes

Principal Investigator

Stephen Spurgeon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000615128

NCT ID:

NCT00764517

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent mantle cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • 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 immunoblastic large cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • Waldenstrom macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239
Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033