Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
31. august 2015 opdateret af: Hoffmann-La Roche
Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
99
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Belgrade, Serbien, 11000
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Belgrade, Serbien, 11080
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Kragujevac, Serbien, 34000
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NIS, Serbien, 18000
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Novi Sad, Serbien, 21000
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Sremska Kamenica, Serbien, 21204
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with follicular lymphoma
Beskrivelse
Inclusion Criteria:
- New diagnosed Stage III/IV NHLs
- Grades 1, 2 follicular lymphoma need to be treated
- mCD20 positive
- Have an expected survival of 3 months or more
- ECOG 0-2 grade
- Normal renal function
- ALT less than double normal level
Exclusion Criteria:
- Presence of CNS lymphoma
- Severe infectious disease or organic disease
- Having another malignant tumor
- Pregnant or breast-feeding female
- Organic heart disease, heart failure, II or higher grade AV bundle block.
- Subject is allergic to Rituximab
- Known HIV infection or chronic HBV infection
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Combination Therapy
Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions.
Chemotherapy according to standard regimens.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
Tidsramme: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data.
An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause.
Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes.
Those specific serious AEs which resulted in fatality were also reported separately.
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Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
Tidsramme: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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Tumor response was evaluated according to criteria published by Cheson et al (1999).
According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement.
PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
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Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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Percentage of Participants With CR According to International Working Group Response Criteria for NHL
Tidsramme: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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Tumor response was evaluated according to criteria published by Cheson et al (1999).
According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement.
The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.
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Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
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Percentage of Participants Alive at 1, 2, and 3 Years
Tidsramme: At 1, 2, and 3 years
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Participants were followed for survival for up to 3 years.
The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.
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At 1, 2, and 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2008
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. november 2013
Datoer for studieregistrering
Først indsendt
29. maj 2015
Først indsendt, der opfyldte QC-kriterier
1. juni 2015
Først opslået (Skøn)
3. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. september 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2015
Sidst verificeret
1. august 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, follikulært
- Lægemidlers fysiologiske virkninger
- Antirheumatiske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Rituximab
Andre undersøgelses-id-numre
- ML21526
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .