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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 agosto 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

Fase

Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Regno Unito
- England
  - Leeds, England, Regno Unito, LS1 3EX
    - Reclutamento
    - Leeds General Infirmary
    - Contatto:
      
      Contact Person
      
      Numero di telefono: 44-113-392-3766
  - London, England, Regno Unito, SW3 6JJ
    - Reclutamento
    - Royal Marsden - London
    - Contatto:
      
      Contact Person
      
      Numero di telefono: 44-20-7352-8171
  - London, England, Regno Unito, SE5 9RS
    - Reclutamento
    - King's College Hospital
    - Contatto:
      
      Contact Person
      
      Numero di telefono: 44-20-3299-9000
  - Manchester, England, Regno Unito, M20 4BX
    - Reclutamento
    - Christie Hospital
    - Contatto:
      
      Contact Person
      
      Numero di telefono: 44-161-446-8565
  - Torbay Devon, England, Regno Unito, TQ2 7AA
    - Reclutamento
    - Torbay Hospital
    - Contatto:
      
      Contact Person
      
      Numero di telefono: 44-180-365-5260

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
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)

Misure di risultato secondarie

Misura del risultato
Intensità relativa della dose
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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cancer Research UK

Investigatori

Cattedra di studio: Roderick Johnson, MD, Leeds General Infirmary

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2007

Completamento primario (Anticipato)

1 maggio 2009

Date di iscrizione allo studio

Primo inviato

20 novembre 2007

Primo inviato che soddisfa i criteri di controllo qualità