- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00009984
Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
I. Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. Compare the incidence of complete and partial remission in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to time to relapse from last fludarabine treatment (less than 6 months vs more than 6 months). Patients are randomized to one of two treatment arms.
Arm I: Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for this study within 1 year.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
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New York
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Bronx, New York, Stati Uniti, 10467-2490
- Montefiore Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Diagnosis of one of the following:
Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:
- Peripheral blood lymphocytosis greater than 5,000/mm^3
- Co-expression of the CD5, CD19, CD20, and CD23 surface antigens
- Clonal kappa and lambda light chain expression
- Dim surface immunoglobulin expression
- Small lymphocytic lymphoma
Relapsed or refractory disease
- Must have received at least 1 prior regimen containing fludarabine
Meets one of the following criteria:
- Recurrence of lymphocytosis greater than 5,000/mm^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR)
- Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m^2/day
- No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome)
- No known CNS disease
- Performance status - Karnofsky 60-100%
- At least 12 weeks
- See Disease Characteristics
- Bilirubin < 2.0 times upper limit of normal (ULN)*
- SGOT < 2.5 times ULN*
- Creatinine < 1.5 times ULN
- No history of cardiac arrhythmia
- No myocardial infarction within the past 6 months
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No active serious infection uncontrolled by antibiotics
- No pre-existing neurotoxicity grade 3 or greater
- No other medical condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Female patients must use 2 effective methods (at least 1 highly active method) of contraception 4 weeks before, during, and for 4 weeks after study participation and male patients must use effective barrier contraception during and for 4 weeks after study participation
- At least 4 weeks since prior biologic therapy and recovered
- No concurrent growth factors (epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])
- See Disease Characteristics
- No more than 3 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No other concurrent chemotherapy
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- Recovered from any prior investigational agents
- No other concurrent investigational agents
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Arm I (thalidomide)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
|
Dato oralmente
Altri nomi:
|
Sperimentale: Arm II (thalidomide, fludarabine phosphate)
Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5.
Treatment with fludarabine repeats every 28 days for 6 courses.
Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.
|
Dato IV
Altri nomi:
Dato oralmente
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Lasso di tempo: Up to 5 years
|
Up to 5 years
|
Incidence of complete and partial remission
Lasso di tempo: Up to 5 years
|
Up to 5 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Richard Furman, Montefiore Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (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 (Stima)
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
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Agenti antibatterici
- Agenti leprostatici
- Talidomide
- Fludarabina
- Fludarabina fosfato
Altri numeri di identificazione dello studio
- NCI-2012-02393
- N01CM62204 (Sovvenzione/contratto NIH degli Stati Uniti)
- NYWCCC-MTS-00-0535ME
- CDR0000068429
- NCI-639
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 .