- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00006226
Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine whether thalidomide can induce objective responses in relapsed B-CLL patients.
II. To determine the toxicity of thalidomide in this patient population. III. To document if alterations in vascular growth factors and/or bone marrow angiogenesis patterns correlate with thalidomide related clinical responses.
OUTLINE:
Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- North Central Cancer Treatment Group
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells
- Relapsed after prior treatment for CLL
Active disease with 1 or more of the following characteristics:
- At least 10% weight loss within the past 6 months
- Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm^3) (i.e., any stage III or IV disease)
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
- Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months)
- Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)
- Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months
- Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease
Measurable disease
- Absolute lymphocyte count greater than 5,000/mm^3
- No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 500/mm^3
- Platelet count at least 20,000/mm^3 (in absence of sargramostim [GM-CSF])
- Hemoglobin at least 8 g/dL
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No other active malignancy
- No peripheral neuropathy (sensory) grade 2 or greater
- No active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion
- No prior allogeneic bone marrow transplantation
- At least 10 days since prior filgrastim (G-CSF) or GM-CSF
- No more than 3 prior chemotherapy regimens
- At least 30 days since prior chemotherapy
- No concurrent corticosteroids except for adrenal insufficiency
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (thalidomide)
Patients receive oral thalidomide daily for 4 weeks.
Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
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Korrelative undersøgelser
Givet PO
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart
Tidsramme: Up to 5 years
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Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
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Up to 5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: Up to 5 years
|
The Kaplan-Meier method will be used.
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Up to 5 years
|
Progression-free survival
Tidsramme: Up to 5 years
|
The Kaplan-Meier method will be used.
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Up to 5 years
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Time to progression
Tidsramme: Up to 5 years
|
The Kaplan-Meier method will be used.
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Up to 5 years
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Varighed af svar
Tidsramme: Op til 5 år
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Op til 5 år
|
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Maximum grade of each type of toxicity
Tidsramme: Up to 5 years
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Frequency tables will be reviewed.
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Up to 5 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Neil Kay, North Central Cancer Treatment Group
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi, B-celle
- Leukæmi
- Leukæmi, lymfatisk, kronisk, B-celle
- Leukæmi, lymfoid
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Antibakterielle midler
- Leprostatiske midler
- Thalidomid
Andre undersøgelses-id-numre
- NCI-2012-01852 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH-bevilling/kontrakt)
- NCCTG-N9986
- CDR0000068148
- N9986 (Anden identifikator: CTEP)
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