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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01386398 |
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Date of registration:
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30/06/2011 |
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Primary sponsor: |
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Public title:
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Vorinostat With or Without Bortezomib in Treating Patients With Refractory or Recurrent Stage IIB, Stage III, or Stage IV Cutaneous T-Cell Lymphoma
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Scientific title:
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Vorinostat (Zolinza®) in Combination With (Velcade®) Versus Vorinostat Alone in Refractory or Recurrent Advanced CTCL: A Randomized Phase III Study. |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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189 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01386398 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Pablo Luis Ortiz-Romero |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario 12 de Octubre |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed advanced cutaneous T-cell lymphoma (CTCL), including its
variants mycosis fungoides and Sézary syndrome
- Stage IIB-IV disease
- Relapsed or refractory disease, including any of the following:
- Patients with clinical progression following EORTC-21081 protocol treatment
- Intolerant to = 1 prior intravenous chemotherapy, including denileukin diftitox,
antibodies or antibody conjugates, or any other systemic therapy
- No CNS involvement
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Absolute neutrophil count > 1.5 x 10^9/L*
- Platelet count > 100 x 10^9/L*
- Hemoglobin > 9 g/dL*
- WBC > 3 x 10^9/L*
- Bilirubin = 1.5 times upper limit of normal (ULN)*
- AST and ALT = 3 times ULN (in case of liver infiltration = 5 x ULN)*
- Serum creatinine = 2.0 mg/dL*
- Calculated creatinine clearance = 60 mL/min
- Electrolytes (including potassium and magnesium) = 1 times ULN*
- Not pregnant or nursing prior to the first dose of study treatment and until 4 weeks
after the last study treatment
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy
- Able to swallow capsules and is able to take or tolerate oral medication on a
continuous basis
- No New York Heart Association class III-IV disease
- None of the following known conditions:
- Infectious disease
- Autoimmune disease
- Immunodeficiency
- No known or active HIV and/or hepatitis A, B, or C infection
- No NCI CTC grade 1 peripheral sensory neuropathy with pain or peripheral sensory or
motor neuropathy = grade II
- No other malignancy within the past 5 years
- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule NOTE: *Patients
with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for
biochemistry are acceptable, except for renal function.
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Must have completely recovered from previous treatment toxicity
- No prior splenectomy or splenic irradiation
- No prior bortezomib and/or histone deacetylase inhibitors (including vorinostat
[SAHA])
- More than 4 weeks since prior chemotherapy, immunotherapy, radiotherapy, or surgery
- In case of clear progression during previous treatment, 2 weeks of wash-out is
enough
- No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery (except biopsies)
- No concurrent steroid (prednisone or equivalent) dose > 20 mg/day
- Prednisone = 20 mg/day for treatment of disorders other than CTCL allowed
- No concomitant use of other histone deacetylase inhibitors (e.g., valproic acid)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma
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Intervention(s)
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Drug: bortezomib
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Drug: vorinostat
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Other: laboratory biomarker analysis
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Primary Outcome(s)
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Progression-free survival
[Time Frame: No]
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Secondary Outcome(s)
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Acute and late toxicity
[Time Frame: Yes]
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Duration of response
[Time Frame: No]
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Overall survival
[Time Frame: No]
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Response rate
[Time Frame: No]
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Second cancers
[Time Frame: No]
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Time to progression
[Time Frame: No]
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Secondary ID(s)
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CDR0000702425
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EORTC-21082
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EU-21116
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EUDRACT-2009-011021-13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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