Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma
CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide, doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in patients with stage I-IV peripheral T-cell lymphoma (PTCL).
- To assess the side effect profile and early and late toxicities of this regimen in a standard dose-escalation design, and to establish an appropriate dose level for future studies.
Secondary
- To document response rates and disease-free survival of patients treated with this regimen, and to compare these findings with those of historical controls.
- To monitor immune reconstitution after therapy.
- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination with CHOP chemotherapy.
- To more clearly define the CD52 expression profile in these tumors and to investigate phenotypic variations in PTCL.
- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase chain reaction during CHOP-alemtuzumab therapy.
OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.
Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline, periodically during study treatment, and after completion of study therapy for pharmacokinetics and other correlative studies to monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and dendritic-cells.
After completion of study therapy, patients are followed every 3 months for the first year, every 6 months for the second year, and then yearly thereafter.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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England
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Leeds, England, Vereinigtes Königreich, LS1 3EX
- Rekrutierung
- Leeds General Infirmary
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Kontakt:
- Contact Person
- Telefonnummer: 44-113-392-3766
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London, England, Vereinigtes Königreich, SW3 6JJ
- Rekrutierung
- Royal Marsden - London
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Kontakt:
- Contact Person
- Telefonnummer: 44-20-7352-8171
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London, England, Vereinigtes Königreich, SE5 9RS
- Rekrutierung
- King's College Hospital
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Kontakt:
- Contact Person
- Telefonnummer: 44-20-3299-9000
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Manchester, England, Vereinigtes Königreich, M20 4BX
- Rekrutierung
- Christie Hospital
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Kontakt:
- Contact Person
- Telefonnummer: 44-161-446-8565
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Torbay Devon, England, Vereinigtes Königreich, TQ2 7AA
- Rekrutierung
- Torbay Hospital
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Kontakt:
- Contact Person
- Telefonnummer: 44-180-365-5260
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes:
- PTCL not otherwise specified
- Angioimmunoblastic T-cell lymphoma
- Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma
- Intestinal T-cell lymphoma
- Bulky stage IA and stages IB-IV disease (Ann Arbor staging system)
- Expression of CD52 by the tumor
- Measurable or evaluable disease
- No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma
- No CNS involvement with non-Hodgkin lymphoma
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- No presence of other serious, uncontrolled medical conditions
- No significant anthracycline-related cardiac impairment
- LVEF ≥ 50%
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 2 times normal value unless due to disease
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment
- No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia
No positive serology or non-consenting to test for any of the following:
- HIV
- Hepatitis B or C
- Human T-lymphotropic virus type 1 (HTLV-1)
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy
- Prior radiotherapy may be allowed at the trial coordinator's discretion
- Concurrent consolidation radiotherapy may be given at the clinician's discretion
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Keine (Offenes Etikett)
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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Immediate toxicity (incidence of infusion-related reactions)
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Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
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Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
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Relative Dosisintensität
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Disease response (remission rate [complete response and partial response])
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Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
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Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
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Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
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Epstein-Barr virus copy number (measured retrospectively)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Roderick Johnson, MD, Leeds General Infirmary
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Dünndarm-Lymphom
- T-Zell-Leukämie/Lymphom im Stadium III bei Erwachsenen
- T-Zell-Leukämie/Lymphom im Stadium IV bei Erwachsenen
- rezidivierende T-Zell-Leukämie/Lymphom bei Erwachsenen
- angioimmunoblastisches T-Zell-Lymphom
- anaplastisches großzelliges Lymphom
- peripheres T-Zell-Lymphom
- T-Zell-Leukämie/Lymphom im Stadium I bei Erwachsenen
- T-Zell-Leukämie/Lymphom im Stadium II bei Erwachsenen
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom, Non-Hodgkin
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Lymphom
- Lymphom, T-Zell
- Lymphom, T-Zelle, peripher
- Darmtumoren
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Entzündungshemmende Mittel
- Antirheumatika
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Glukokortikoide
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Antineoplastische Mittel, hormonell
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Myeloablative Agonisten
- Antineoplastische Mittel, Phytogen
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Antineoplastische Mittel, immunologische
- Antibiotika, antineoplastische
- Prednisolon
- Cyclophosphamid
- Doxorubicin
- Liposomales Doxorubicin
- Vincristin
- Alemtuzumab
Andere Studien-ID-Nummern
- CDR0000576439
- UCL-BRD/05/170
- EU-20785
- EUDRACT-2006-000365-11
- CTA 21786/0201/001-0001
- CRUK-UCL-BRD/05/170-CHOP-CAMPA
- UCL-CHOP-CAMPATH
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