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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New York
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Bronx, New York, Verenigde Staten, 10467-2490
- Montefiore Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm I (thalidomide)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
|
Mondeling gegeven
Andere namen:
|
|
Experimenteel: 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.
|
IV gegeven
Andere namen:
Mondeling gegeven
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
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Incidence of complete and partial remission
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Richard Furman, Montefiore Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Leukemie, B-cel
- Leukemie
- Leukemie, lymfatische, chronische, B-cel
- Leukemie, Lymfoïde
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Antibacteriële middelen
- Leprostatische middelen
- Thalidomide
- Fludarabine
- Fludarabine-fosfaat
Andere studie-ID-nummers
- NCI-2012-02393
- N01CM62204 (Subsidie/contract van de Amerikaanse NIH)
- NYWCCC-MTS-00-0535ME
- CDR0000068429
- NCI-639
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