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Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma

23. august 2013 opdateret af: Cancer Research UK

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Det Forenede Kongerige
- England
  - Leeds, England, Det Forenede Kongerige, LS1 3EX
    - Rekruttering
    - Leeds General Infirmary
    - Kontakt:
      
      Contact Person
      
      Telefonnummer: 44-113-392-3766
  - London, England, Det Forenede Kongerige, SW3 6JJ
    - Rekruttering
    - Royal Marsden - London
    - Kontakt:
      
      Contact Person
      
      Telefonnummer: 44-20-7352-8171
  - London, England, Det Forenede Kongerige, SE5 9RS
    - Rekruttering
    - King's College Hospital
    - Kontakt:
      
      Contact Person
      
      Telefonnummer: 44-20-3299-9000
  - Manchester, England, Det Forenede Kongerige, M20 4BX
    - Rekruttering
    - Christie Hospital
    - Kontakt:
      
      Contact Person
      
      Telefonnummer: 44-161-446-8565
  - Torbay Devon, England, Det Forenede Kongerige, TQ2 7AA
    - Rekruttering
    - Torbay Hospital
    - Kontakt:
      
      Contact Person
      
      Telefonnummer: 44-180-365-5260

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Immediate toxicity (incidence of infusion-related reactions)
Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
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)

Sekundære resultatmål

Resultatmål
Relativ dosisintensitet
Disease response (remission rate [complete response and partial response])
Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
Pharmacokinetics assessment of alemtuzumab trough levels before each cycle of treatment
Epstein-Barr virus copy number (measured retrospectively)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cancer Research UK

Efterforskere

Studiestol: Roderick Johnson, MD, Leeds General Infirmary

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Phillips EH, Devereux S, Radford J, Mir N, Adedayo T, Clifton-Hadley L, Johnson R. Toxicity and efficacy of alemtuzumab combined with CHOP for aggressive T-cell lymphoma: a phase 1 dose-escalation trial. Leuk Lymphoma. 2019 Sep;60(9):2291-2294. doi: 10.1080/10428194.2019.1576870. Epub 2019 Feb 18. No abstract available.

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. maj 2007

Primær færdiggørelse (Forventet)

1. maj 2009

Datoer for studieregistrering

Først indsendt

20. november 2007

Først indsendt, der opfyldte QC-kriterier