NCT00725231

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

6.1 years

First QC Date

July 25, 2008

Last Update Submit

May 4, 2012

Conditions

Peripheral T Cell Lymphoma, UnspecifiedAngioimmunoblastic LymphadenopathyExtranodal NK/T-cell Lymphoma

Keywords

T cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Event free survival

    3 years

Secondary Outcomes (5)

  • Rate of complete and partial remissions

    4 months after inclusion

  • treatment related deaths

    time of occurence

  • Overall survival

    @ 3 years

  • protocol adherence

    4 months of treatment

  • immune reconstitution after alemtuzumab CHOP

    3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Chemotherapy with dose dense CHOP-14, 6 cycles

Drug: chemotherapy

Arm B

EXPERIMENTAL

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

Biological: alemtuzumabDrug: chemotherapy

Interventions

alemtuzumabBIOLOGICAL

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

Also known as: monoclonal anti CD52 antibody
Arm B
chemotherapyDRUG

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

Also known as: chemotherapy cylcophosphamide, hydroxyldaunorubicin
Arm AArm B

Eligibility Criteria

Age61 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Göttingen

Göttingen, Lower Saxony, 37099, Germany

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-CellImmunoblastic LymphadenopathyLymphoma, Extranodal NK-T-Cell

Interventions

AlemtuzumabDrug TherapyDoxorubicin

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeuticsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Lorenz H Trümper, MD

    University of Göttingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz H Trümper, MD

CONTACT

+49 551 398535lorenz.truemper@med.uni-goettingen.de

Gerald G Wulf, MD

CONTACT

+49 551 396303gwulf@med.uni-goettingen.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Departement of Haemtology and Oncology

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 30, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

DE(1)