- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00510887
Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.
All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
- No prior bortezomib therapy.
- Voluntary written informed consent.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
- Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
- 18 years of age or older.
- aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion Criteria:
- Platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
- Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
- Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
- ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
- Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
- Female subject is pregnant or lactating.
- Received other investigational drugs for this disease within 14 days of enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Known HIV+ status.
- Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: VR-FND
Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. |
Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Andra namn:
Rituximab 375 mg/m2 IV on day 1
Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone 10 mg/m2 IV on day 2
Andra namn:
Dexamethasone 20 mg orally on days 1,2,3,4,5
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Complete and Partial Response
Tidsram: 1 year
|
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Duration of Response
Tidsram: up to 4 years
|
Duration of response is measured from time of treatment to time of disease progression
|
up to 4 years
|
Percentage of Subjects Experiencing Progression Free Survival
Tidsram: up to 2 years
|
Progression free survival is measured from treatment to progression or death, whichever comes first.
Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.
|
up to 2 years
|
Percentage of Subjects Experiencing Overall Survival
Tidsram: up to 2 years
|
Overall survival is from the day of enrollment to date of death from any cause.
|
up to 2 years
|
Number of Participants With a Grade 3-4 Hematologic Toxicity.
Tidsram: up to 1 year
|
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s).
Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).
|
up to 1 year
|
Number of Participants With Neuropathy, Any Grade
Tidsram: up to 1 year
|
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s).
Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).
|
up to 1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom
- Lymfom, follikulärt
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel
- Antireumatiska medel
- Antineoplastiska medel
- Immunologiska faktorer
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antineoplastiska medel, immunologiska
- Dexametason
- Rituximab
- Bortezomib
- Fludarabin
- Mitoxantron
Andra studie-ID-nummer
- Pro00008487
- 8785 (DUMC old IRB number)
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