Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL
26. mai 2016 oppdatert av: Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute
A Phase I Dose Escalation Study of Lenalidomide (Revlimid) in Combination With Fludarabine-Rituximab (Rituxan) for Previously Untreated CLL/SLL
The purpose of this study is to determine the safety of lenalidomide (revlimid) in combination with fludarabine and rituximab and to determine the highest dose of lenalidomide that can safely be given in that combination.
Lenalidomide is a drug that alters the immune system and may also interfere with the the development of tiny blood vessels that help support tumor growth.
Lenalidomide is approved by the FDA for the treatment of two different blood cancers called myelodysplastic syndrome and multiple myeloma.
Lenalidomide has also been studied in subjects with relapsed CLL.
In this research study we are adding lenalidomide to a well-established initial therapy for CLL/SLL.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
- Participants will be treated in groups (cohorts) of three to six subjects per cohort. The dose of lenalidomide or fludarabine will be increased from one cohort to the next. Regardless of the treatment cohort, participants will receive treatment in cycles lasting 28 days.
- For the first 3-5 days (depending on the group), participants will be treated on an outpatient basis in the infusion room at the Dana-Farber Clinic, with fludarabine and rituximab. Fludarabine is given intravenously for 3-5 days. Rituximab is given intravenously on day 1 of each 28-day cycle. Lenalidomide is given orally once per day for 3 weeks, followed by 1 week of rest.
- Participants will be monitored very closely during the study treatment. During the first 28 day period (cycle 1), a physical exam and routine blood tests will be performed weekly. All participants in a group must finish the first 28-day treatment period before we proceed with the next group. Once started on study treatment, participants will continue for six cycles (a cycle is 28 days) of combination therapy with all three drugs. During that period they will have a physical exam and routine blood tests on day 1 of each treatment cycle, and additional blood tests on day 15 of each cycle.
- When participants complete 6 cycles of combination therapy, they will proceed with two additional months of the lenalidomide alone, for 21 out of 28 days.
- Disease response will be evaluated after 2, 6, and 8 months of study treatment. The following tests and procedures will be performed: Physical exam; blood tests; CT scans to evaluate lymph nodes; skin testing; and bone marrow biopsy if all other tests show no evidence of any remaining CLL and if the baseline bone marrow biopsy was positive
- Participants will have a physical exam and lab work every 3 months as long as their disease remains in remission.
Studietype
Intervensjonell
Registrering (Faktiske)
9
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Diagnosed with B-CLL/SLL based on the standard histologic and immunophenotypic criteria described in the WHO classification
- No prior systemic therapy for CLL/SLL, including chemotherapy or antibody therapy
- Currently needs therapy based on 1996 NCI-WG criteria
- Measurable disease
- ECOG Performance Status of 0-2
- Laboratory test results within parameters outlined in protocol
- Able to take aspirin daily as prophylactic anticoagulation
Exclusion Criteria:
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document
- Pregnant or breast-feeding females
- Any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Use of any other experimental drug or therapy within 28 days of baseline
- Known hypersensitivity to thalidomide
- Development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
- Prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments
- Known positive for HIV
- Chronic active Hep B patients not on prophylactic lamivudine
- Diagnosis of Mantle Cell Lymphoma
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lenalidomide, fludarabine and rituximab
Lenalidomide-Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period fludarabine- Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days Rituximab- Given intravenously on Day 1 of each 28 day cycle
|
Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period
Andre navn:
Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days
Given intravenously on Day 1 of each 28 day cycle
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To evaluate the safety of lenalidomide in combination with fludarabine-rituximab (FR) and to determine the maximum tolerated dose in subjects with previously untreated CLL/SLL.
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To determine the objective response rate and progression-free survival following lenalidomide/FR in this patient population
Tidsramme: 2 years
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2 years
|
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To determine the improvement in ORR following two months of consolidation lenalidomide after completion of combination therapy
Tidsramme: 2 years
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2 years
|
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To assess effects on immune function as measured by cytokine levels, T and NK cell subsets, T cell activation during therapy and DTH vaccine responses.
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jennifer R. Brown, MD, PhD, Dana-Farber Cancer Institute
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2007
Primær fullføring (Faktiske)
1. juni 2009
Studiet fullført (Faktiske)
1. desember 2012
Datoer for studieregistrering
Først innsendt
10. oktober 2007
Først innsendt som oppfylte QC-kriteriene
10. oktober 2007
Først lagt ut (Anslag)
12. oktober 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Leukemi, B-celle
- Leukemi
- Leukemi, lymfatisk, kronisk, B-celle
- Leukemi, lymfoid
- Fysiologiske effekter av legemidler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Lenalidomid
- Rituximab
- Fludarabin
Andre studie-ID-numre
- 07-097
- RV-0162
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .