Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

NCT ID: NCT00725231

Last Updated: 2012-05-07

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

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-03-31

Brief Summary

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Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

Detailed Description

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Conditions

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Peripheral T Cell Lymphoma, Unspecified Angioimmunoblastic Lymphadenopathy Extranodal NK/T-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Chemotherapy with dose dense CHOP-14, 6 cycles

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Arm B

Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles

Group Type EXPERIMENTAL

alemtuzumab

Intervention Type BIOLOGICAL

Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles

chemotherapy

Intervention Type DRUG

dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Interventions

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alemtuzumab

Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles

Intervention Type BIOLOGICAL

chemotherapy

dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Intervention Type DRUG

Other Intervention Names

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monoclonal anti CD52 antibody chemotherapy cylcophosphamide, hydroxyldaunorubicin

Eligibility Criteria

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Inclusion Criteria

* all risk groups of peripheral T cell lymphoma
* performance status ECOG 0-2
* written consent
* measurable disease

Exclusion Criteria

* stage I N without bulky disease
* already initiated treatment
* serious accompanying disorder or impaired organ function
* bone marrow involvement \>25%
* HIV positivity
* leukemic manifestation of lymphoma
* simultaneous participation in another trial
* platelets \< 100 000/ mm, leukocytes \< 2500 /mm
Minimum Eligible Age

61 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German High-Grade Non-Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role collaborator

Nordic Lymphoma Group

NETWORK

Sponsor Role collaborator

University of Göttingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Lorenz Trümper

Head of Departement of Haemtology and Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorenz H Trümper, MD

Role: PRINCIPAL_INVESTIGATOR

University of Göttingen

Locations

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University of Göttingen

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Lorenz H Trümper, MD

Role: CONTACT

+49 551 398535 ext. 8535

Gerald G Wulf, MD

Role: CONTACT

+49 551 396303 ext. 6303

Other Identifiers

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BMBF GFVT 01014715

Identifier Type: -

Identifier Source: secondary_id

DSHNHL 2006-1B / ACT-2

Identifier Type: -

Identifier Source: org_study_id

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