NCT00791947

Brief Summary

This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma. The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_2

Geographic Reach
3 countries

9 active sites

Status
completed

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

October 1, 2001

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 8, 2011

Status Verified

September 1, 2011

Enrollment Period

6.8 years

First QC Date

November 14, 2008

Last Update Submit

September 7, 2011

Conditions

Peripheral T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Time to treatment failure

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Interventions

CHOEP + G-CSF followed by BEAMDRUG

CHOEP: Cyclophosphamide: 750 mg/m2 i.v. day1 Hydroxydaunorubicin: 50 mg/m2 i.v. day1 Vincristine: 1.4 mg/m2 (max 2 mg) i.v. day 1 Etoposide: 100 mg/m2 i.v. day 1-3 Prednisone: 100 mg daily p.o. day 1-5 BEAM: Carmustine: 300 mg/m2 i.v. day 1 Etoposide: 100 mg/m2 i.v. x2 daily day 2-5 Cytosine arabinoside: 200 mg/m2 i.v. x2 daily or 400 mg/m2 as continuous 24 hrs i.v. infusion, day 2-5 Melphalan: 140 mg/m2 i.v. day 6

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (\<10cm) can be treated individually at the discretion of the responsible physician.
  • Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
  • NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
  • Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
  • formed consent based on oral and written patient information (Appendix I)

You may not qualify if:

  • Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
  • Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
  • WHO Performance Status grade 4 (Appendix II)
  • Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
  • Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
  • Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Patients with seropositivity for the human immunodeficiency virus.
  • Patients with other active and therapeutically uncontrolled infection.
  • Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Copenhagen Hospital

Copenhagen, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

OULO University Hospital

Oulu, Oulo, Finland

Location

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Oslo University Hospital

Oslo, 0310, Norway

Location

Ullevaal University Hospital

Oslo, 0407, Norway

Location

Rogaland Hospital

Rogaland, Norway

Location

St.Olavs Hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Francesco d'Amore, MD

    Nordic Lymphoma Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

October 1, 2001

Primary Completion

August 1, 2008

Study Completion

August 1, 2010

Last Updated

September 8, 2011

Record last verified: 2011-09

Locations

FI(2)DK(3)NO(4)