- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00365274
SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the efficacy of monoclonal antibody SGN-30 in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients with newly diagnosed anaplastic large cell lymphoma (ALCL).
II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.
SECONDARY OBJECTIVES:
I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
II. Determine the response duration in patients treated with this regimen.
III. Correlate response with pretreatment serum CD30 levels.
IV. Determine response to single-agent monoclonal antibody SGN-30.
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large cell kinase (ALK) status (positive vs negative).
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over 2 hours once weekly for 3 weeks.
Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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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:
- Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL)
- Tissue available for the determination of anaplastic large cell kinase (ALK) status [t(2;5), ALK-NPM translocation] prior to study entry
- Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment
- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
- White Blood Count (WBC) >= 3,000/mm³
- Absolute neutrophil count >= 1,500/mm³
- Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone marrow involvement])
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- AST or ALT =< 2.5 times ULN
- Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60 mL/min
- Left ventricular ejection fraction (LVEF) >= 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Exclusion Criteria:
- No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in largest diameter
- No primary cutaneous ALCL
- No known brain metastases
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study compliance
- No prior or other concurrent malignancy with < 90% probability of survival at 5 years
- No other concurrent anticancer agents or therapies
- No prior chemotherapy for ALCL
- No other concurrent investigational agents
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: SGN-30 + Combination Chemotherapy
Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously(IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses. |
Given IV 750 mg/m^2 day 1
Andre navne:
Given 50 mg/m^2 IV day 1
Andre navne:
Given 1.4 mg/m^2 IV
Andre navne:
100 mg orally daily days 1 - 5
Andre navne:
12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Objective Response Rate (ORR)
Tidsramme: Up to 5 years
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Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL).
The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.
A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
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Up to 5 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michelle Fanale, MD, UT MD Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (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
Nøgleord
- Sygdomme i immunsystemet
- Neoplasmer
- Lymfom
- Antibiotika
- NHL
- Lymfom, Non-Hodgkin
- Cyclofosfamid
- Antineoplastiske midler
- Vincristine
- Lægemidlers fysiologiske virkninger
- Antistoffer, monoklonale
- Farmakologiske handlinger
- Prednison
- HAKKE
- Antistoffer
- anaplastisk storcellet lymfom
- Antineoplastisk
- Terapeutiske anvendelser
- Lymfom, B-celle
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfesygdomme
- Immunologiske faktorer
- Neoplasmer efter histologisk type
- Immunsuppressive midler
- non-Hodgkins lymfom
- Lymfom, storcellet, anaplastisk
- Lymfom, stor B-celle, diffus
- Alkyleringsmidler
- Molekylære mekanismer for farmakologisk virkning
- mAb
- Lymfom, T-celle
- Antineoplastiske midler, Alkylering
- Myeloablative agonister
- Doxorubicin Hydrochlorid
- Antirheumatiske midler
- murine monoclonal antibody
- SGN-30
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Lymfom, T-celle
- Lymfom
- Lymfom, Non-Hodgkin
- Lymfom, storcellet, anaplastisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antineoplastiske midler, immunologiske
- Antibiotika, antineoplastisk
- Cyclofosfamid
- Prednison
- Doxorubicin
- Liposomal doxorubicin
- Vincristine
- Brentuximab Vedotin
Andre undersøgelses-id-numre
- NCI-2009-00162
- N01CM62202 (U.S. NIH-bevilling/kontrakt)
- N01CM17003 (U.S. NIH-bevilling/kontrakt)
- 2005-0627 (Anden identifikator: UT MD Anderson Cancer Center)
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