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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma Small Intestine Cancer

Keywords

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recurrent adult T-cell leukemia/lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma small intestine lymphoma peripheral T-cell lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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alemtuzumab

Intervention Type BIOLOGICAL

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

prednisolone

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

polymerase chain reaction

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roderick Johnson, MD

Role: STUDY_CHAIR

Leeds General Infirmary

Locations

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Leeds General Infirmary

Leeds, England, United Kingdom

Site Status RECRUITING

King's College Hospital

London, England, United Kingdom

Site Status RECRUITING

Royal Marsden - London

London, England, United Kingdom

Site Status RECRUITING

Christie Hospital

Manchester, England, United Kingdom

Site Status RECRUITING

Torbay Hospital

Torbay Devon, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Contact Person

Role: primary

Contact Person

Role: primary

Contact Person

Role: primary

Contact Person

Role: primary

Contact Person

Role: primary

References

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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.

Reference Type DERIVED

PMID: 30773077 (View on PubMed)