Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

23 oktober 2018 bijgewerkt door: Georgetown University

Lenalidomide Following Rituximab and Fludarabine in Untreated Chronic Lymphocytic Leukemia

This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease.

Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this research because we are attempting to improve the response, or outcome, of Fludarabine and Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

This research is being done because we are attempting to find a better treatment for chronic lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of Fludarabine and Rituximab.

The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and Rituximab alone.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a single institution Phase II study where all enrolled patients with untreated CLL will receive fludarabine and rituximab (FR) combination therapy. Subjects who demonstrate Stable disease or Progressive disease after completing 3 cycles of FR will receive lenalidomide monotherapy for a maximum of 6 cycles. Subjects who achieve >/= PR after receiving 3 cycles of FR will receive 3 additional cycles of FR (maximum of 6 cycles). Upon completion of FR treatment subjects will receive lenalidomide monotherapy for a maximum of 6 cycles.

Response assessment will be performed for Module A (FR): after every cycle, but would include imaging after cycle 3 if clinically indicated. Response assessment will be performed for Module B (Lenalidomide monotherapy): Before starting Lenalidomide therapy, after every cycle and on completion of therapy. Imaging for Module B would be obtained before starting lenalidomide therapy, and on completion of therapy. Bone marrow biopsies will be performed prior to starting therapy in Module A (FR), prior to starting Module B (Lenalidomide), and on completion of Module B. Bone marrow biopsies can be obtained once during Lenalidomide therapy at the discretion of the investigator. Minimum residual disease assessment of bone marrow specimens should include immunohistochemistries and flow cytometry. Additional studies on bone marrow specimens will be sent for flow cytometric analysis (standard or four color flow), ZAP-70 immunohistochemical stains and FISH analysis (13q deletion, trisomy 12, 11q deletion, and 17p) will be performed at the time intervals described above.

Response will be assessed according to the Cheson Criteria.

Blood specimens for optional correlative studies will be drawn on Day 0 prior to FR, prior to starting lenalidomide, 90 days after initiation of lenalidomide, and 7 days after the last dose of lenalidomide.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

22

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Understand and voluntarily sign informed consent form
  • No prior therapy for CLL
  • Able to adhere to study visit schedule and other protocol requirements
  • CLL with any Rai Stage requiring therapy
  • ECOG performance status </= 2
  • Absolute neutrophil count >/= 1.0
  • Platelet count >/= 75
  • Serum creatinine </= 1.5
  • Total bilirubin </= 1.5
  • AST and ALT </= 2 x ULN
  • Females of childbearing potential must have negative pregnancy test
  • Disease free of prior malignancies for >/= 5 years
  • Able to take aspirin daily as prophylactic anticoagulation

Exclusion Criteria:

  • Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or lactating females
  • Any condition, including the presence of lab 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
  • Concurrent use of other anti-cancer agents or treatments
  • Known positive for HIV or infectious active hepatitis, type A, B
  • Known hypersensitivity to nucleoside analogue or rituximab
  • Previous treatment for CLL prior to enrolling in study
  • Known hypersensitivity to thalidomide
  • The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide
  • Active hemolysis

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Chemotherapy
Fludarabine/Rituximab followed by Lenalidomide
Geneesmiddel: Rituximab
375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
Andere namen:
  • Rituxan
Geneesmiddel: Fludarabine
25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
Andere namen:
  • Fludara
Geneesmiddel: Lenalidomide
5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Andere namen:
  • Revlimid

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Complete Response Rate
Tijdsspanne: 3 years
Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.
3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Georgetown University

Medewerkers

Celgene Corporation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2008

Primaire voltooiing (Werkelijk)

1 maart 2011

Studie voltooiing (Werkelijk)

1 februari 2012

Studieregistratiedata

Eerst ingediend

10 maart 2009

Eerst ingediend dat voldeed aan de QC-criteria

11 maart 2009

Eerst geplaatst (Schatting)

12 maart 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 november 2018

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2018

Laatst geverifieerd

1 augustus 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RV-CLL-PI-089

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Rituximab

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Slovenia

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren