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- Klinische proef NCT00073749
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
14 december 2018 bijgewerkt door: Pfizer
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
79
Fase
- Fase 1
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
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Leuven, België, 3000
- Universitair Ziekenhuis Gasthuisberg
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Mainz, Duitsland, 55131
- Universitaetsmedizin der Johannes Gutenberg-Universitaet
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Muenchen, Duitsland, 81377
- Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern
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Muenchen, Duitsland, 81377
- Universitaet Muenchen Klinikum Grosshadern
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NRW
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Bonn, NRW, Duitsland, 53105
- Universitätsklinikum Bonn
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Paris, Frankrijk, 75010
- Hopital Saint Louis
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Pierre Benite Cedex, Frankrijk, 69495
- Centre Hospitalier Lyon-Sud
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Barcelona, Spanje, 08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona, Spanje, 08036
- Hospital Clinic I Provincial
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London, Verenigd Koninkrijk, EC1A 7BE
- St Bartholomew's Hospital
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Verenigde Staten, 35233
- UAB CCC Clinical Studies Unit
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Birmingham, Alabama, Verenigde Staten, 35233
- University of Alabama at Birmingham Kirklin Clinic
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Birmingham, Alabama, Verenigde Staten, 35294
- UAB Russell Ambulatory Pharmacy
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern Medical Faculty Foundation
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New York
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- The Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Verenigde Staten, 77030-4009
- M.D. Anderson Cancer Center
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Lausanne, Zwitserland, 1011
- Centre Hospitalier Universitaire Vaudois
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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 tot 99 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
- At the expanded cohort, part 2 of the study, subjects must have one of the following:
- Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
- Diffuse large B-cell lymphoma
- Age 18 years or older
Exclusion Criteria:
- Candidate for potentially curative therapies in the opinion of the investigator
- Chronic lymphocytic leukemia
- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
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: Niet-gerandomiseerd
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
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CMC-544, IV, dose escalation trial
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tijdsspanne: Baseline up to 42 days after last dose of study drug (up to Day 225)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period.
AEs included both SAEs and non-serious adverse events (non-SAEs).
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
Tijdsspanne: Baseline up to 42 days after last dose of study drug (up to Day 225)
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AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study.
AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE).
Participants with Grade 3 or higher grades TEAEs were reported.
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Baseline up to 42 days after last dose of study drug (up to Day 225)
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Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
Tijdsspanne: Baseline up to Day 28
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MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT).
DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
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Baseline up to Day 28
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Number of Participants With Dose-limiting Toxicity (DLT)
Tijdsspanne: Baseline up to Day 28
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DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
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Baseline up to Day 28
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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PFS was based on Kaplan-Meier estimates.
PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline up to Year 5
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OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline up to Year 5
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Interval OS was based on Kaplan-Meier method.
Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline up to Year 5
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Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
Tijdsspanne: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
Tijdsspanne: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment.
This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
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Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
Tijdsspanne: Baseline up to 42 days after last dose (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose (Day 225)
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Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
Tijdsspanne: Baseline up to 42 days after last dose of study drug (Day 225)
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Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL.
CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate.
CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow.
PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
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Baseline up to 42 days after last dose of study drug (Day 225)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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 (Werkelijk)
1 augustus 2003
Primaire voltooiing (Werkelijk)
1 december 2010
Studie voltooiing (Werkelijk)
1 december 2010
Studieregistratiedata
Eerst ingediend
4 december 2003
Eerst ingediend dat voldeed aan de QC-criteria
4 december 2003
Eerst geplaatst (Schatting)
5 december 2003
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 december 2018
Laatste update ingediend die voldeed aan QC-criteria
14 december 2018
Laatst geverifieerd
1 december 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Lymfoom, B-cel
- Lymfoom, non-Hodgkin
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Antibiotica, antineoplastiek
- Inotuzumab Ozogamicin
Andere studie-ID-nummers
- 3129K1-100
- B1931002 (Andere identificatie: Alias Study Number)
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 Lymfoom, B-cel
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Peking University People's HospitalOnbekendNatural Killer Cell-gemedieerde immuniteitChina
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); NovartisActief, niet wervendRefractaire Hurthle Cell-schildklierkankerVerenigde Staten
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Hadassah Medical OrganizationOnbekendNatural Killer Cell-deficiëntie, familiaal geïsoleerdIsraël
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Assistance Publique - Hôpitaux de ParisNog niet aan het werven
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Bing HanVoltooidPure Red Cell Aplasia, verworvenChina
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Peking University First HospitalWervingNiercelcarcinoom, Clear Cell, SomatischChina
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National Institute of Diabetes and Digestive and...WervingSchildklierkanker | Papillaire schildklierkanker | Hurthle Cell-schildklierkanker | Tall Cell Variant Schildklierkanker | Folliculaire schildklierkankerVerenigde Staten
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ExelixisVoltooidNiercelcarcinoom | Papillaire schildklierkanker | Folliculaire schildklierkanker | Huerthle Cell-schildklierkankerVerenigde Staten
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Jeadran N. Malagón-RojasNog niet aan het wervenStress, psychisch | Ongerustheid | Blootstelling aan het milieu | Cortisol-overschot | Epigenetische stoornis | Natural Killer Cell Cytokine-productieColombia
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
Klinische onderzoeken op Inotuzumab ozogamicin [CMC-544]
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Wyeth is now a wholly owned subsidiary of PfizerVoltooid
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Institute of Hematology & Blood Diseases HospitalNog niet aan het werven
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PfizerUCB PharmaVoltooidAcute lymfatische leukemieVerenigde Staten
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PfizerVoltooidVoorlopercel lymfoblastische leukemie-lymfoomVerenigd Koninkrijk
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)BeëindigdTerugkerende acute lymfoblastische leukemie | Refractaire acute lymfoblastische leukemie | CD22 PositiefVerenigde Staten
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PfizerVoltooid
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PfizerUCB PharmaVoltooidB-cel lymfoomVerenigde Staten, België, Korea, republiek van, Zwitserland, Frankrijk, Polen, Spanje, Hongkong, Australië, Duitsland, Italië, Nederland, Verenigd Koninkrijk
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M.D. Anderson Cancer CenterWyeth is now a wholly owned subsidiary of PfizerVoltooidAcute lymfatische leukemieVerenigde Staten
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WervingAcute lymfatische leukemie | B Acute lymfoblastische leukemie | Terugkerende B acute lymfoblastische leukemieVerenigde Staten
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Cristiana SessaVoltooidB-cel lymfoom refractairZwitserland