- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01133743
Open-Label Study of Lenalidomide in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia
An Open-Label Phase 2 Study of Lenalidomide (Revlimid) in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia (CLL)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network - Princess Margaret Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- A confirmed diagnosis of B-cell CLL by IWCLL 2008 criteria
No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias (anemia or thrombocytopenia) is NOT considered a prior systemic therapy.
Radiation: Patients may have received prior radiation therapy restricted to </= 25% of functioning bone marrow. Patients must be >/= 4 weeks since last treatment with radiation therapy.
Surgery: previous surgery is permissible. Patient must be >/= 4 weeks since any major surgery.
Patients must have symptomatic disease requiring therapy as per the IWCLL 2008 criteria. One or more of the following must be present to be eligible:
- Massive (>10cm diameter), progressive or symptomatic lymphadenopathy
- Massive (>6 cm below costal margin) or progressive or symptomatic splenomegaly
- Anemia (Hb <110 g/L)
- Thrombocytopenia (platelets <100 x 109/L)
- Constitutional symptoms (one of the following):
- Weight loss >10% or more over previous 6 months
- Significant fatigue
- Fevers >38 degrees Celsius for 2 or more weeks without infection
- Night sweats > 1 month without evidence of infection
- Other constitutional symptoms felt to require treatment as per treating physician discretion
- Persistent rise in lymphocyte count with doubling time of < 6 months
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
- ECOG performance status of </= 2 at study entry
- Laboratory Requirements: (must be done within 7 days prior to first study drug dose) Hematology: Absolute granulocytes (AGC)>/= 1000/mm³ Platelets >/= 50,000/mm³ Chemistry: Creatinine clearance>/= 30ml/min (by Cockcroft-Gault calculation, see Appendix 9) Bilirubin </= 1.5 x UNL AST (or ALT if AST not available) </= 2.5 x UNL
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
- Able to take aspirin 81 mg daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion criteria:
Patients who fulfill any of the following criteria are not eligible for admission to the study:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type B or C.
- Known intolerance to steroids (i.e. poorly controllable hyperglycemia or hypertension, significant mood disturbances, steroid-related myopathy, etc.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Lenalidomide and Dexamethasone
Lenalidomide target dose of 25 mg PO OD continuously (28-day cycle) using an initial dose escalation period.
Oral dexamethasone 12 mg daily on days 1-7, 14 and 21 of each cycle.
|
Starting Lenalidomide dose 2.5 mgs or 5 mgs (based on baseline calculated creatinine clearance)PO daily on a 28 day cycle.
Dose escalations will take place at the start of subsequent cycles as frequently as tolerated but not more frequently than at the start of each cycle to a target dose of 25mg daily.
Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Response rate
Lasso di tempo: 18 cycles (each cycle is of 28 days)
|
18 cycles (each cycle is of 28 days)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Time to progression
Lasso di tempo: Participants will be followed until death
|
Participants will be followed until death
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Dr. Christine I Chen, MD, University Health Network, Toronto
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Leucemia
- Leucemia, linfocitica, cronica, cellule B
- Leucemia, linfoide
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Agenti antibatterici
- Agenti leprostatici
- Desametasone
- Talidomide
- Lenalidomide
Altri numeri di identificazione dello studio
- RV-CLL-PI-0411
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Lenalidomide and Dexamethasone
-
Dalarna UniversityUppsala University; The Swedish Research CouncilReclutamentoDemenza | Compromissione cognitiva lieve | Demenza, mista | Demenza di tipo Alzheimer | Compromissione cognitiva soggettiva | Demenza senileSvezia
-
Bournemouth UniversityRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustCompletatoEffetto della formazioneRegno Unito
-
Institut du Cancer de Montpellier - Val d'AurelleUniversity Hospital, Clermont-Ferrand; Laboratoire EPSYLON; Academic resource center...Completato
-
Samsung ElectronicsCompletatoInvecchiato | Adulti | Mezza età | Di età compresa tra 80 e oltreCorea, Repubblica di
-
Indiana UniversityUniversity of South Florida; National Institute on Minority Health and Health... e altri collaboratoriCompletatoIntervento DECIDE modificato | Trattamento come consueto gruppo di curaStati Uniti
-
University of Illinois at Urbana-ChampaignSconosciutoInfortunio da caduta | Prevenzione delle cadute | Sicurezza anticaduta
-
Montefiore Medical CenterAmerican Psychological FoundationNon ancora reclutamentoDepressione postparto | Ansia post parto | Stress genitoriale | Relazioni genitore figlioStati Uniti
-
University Hospital, Clermont-FerrandNon ancora reclutamentoStress occupazionale | Comportamento sedentarioFrancia
-
University of Illinois at ChicagoCompletatoAnziani saniStati Uniti
-
Institut de Cancérologie de la LoireCompletato