NCT00970385

Brief Summary

This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

January 1, 1995

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

7.9 years

First QC Date

August 20, 2009

Last Update Submit

September 8, 2009

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.

    2 years

Secondary Outcomes (4)

  • Overall survival (OS)

    6 years

  • response rate at the end of the treatment

    6-8 months

  • progression free survival (PFS)

    6 years

  • hematotoxicity

    6 months

Study Arms (2)

CHOP 21

ACTIVE COMPARATOR

Induction therapy CHOP every 21 days: * cyclophosphamide 750 mg/m2 intravenously (IV) day 1 * doxorubicin 50 mg/m2 IV day 1 * vincristine 1,4 mg/m2 (maximum 2 mg) day 1 * prednisone 100 mg/m2/D from D1 to D5.

Drug: CHOP21Radiation: Radiotherapy consolidation

VIP/ABVD arm

EXPERIMENTAL

VIP cycle: * etoposide 100 mg/m2/D IV from D1 to D3 * ifosfamide 1000 mg/m2/D from D1 to D5 * cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5 ABVD cycle: * doxorubicin50 mg/m2/D on D1 and D14 * bleomycin 10 mg/m2/D * vinblastine 10 mg/m2/D * dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD).

Drug: VIP/ABVDRadiation: Radiotherapy consolidation

Interventions

CHOP21DRUG

CHOP regimen: * cyclophosphamide 750 mg/m2 intravenously (IV) day 1 * doxorubicin 50 mg/m2 IV day 1 * vincristine 1,4 mg/m2 (maximum 2 mg) day 1 * prednisone 100 mg/m2/D from D1 to D5.

Also known as: CHOP 21 arm
CHOP 21
VIP/ABVDDRUG

VIP regimen: * etoposide 100 mg/m2/D IV from D1 to D3 * ifosfamide 1000 mg/m2/D from D1 to D5 * cisplatinum 20 mg/m2/D as a continuous infusion from D1 to D5 ABVD regimen: * doxorubicin50 mg/m2/D on D1 and D14 * bleomycin 10 mg/m2/D * vinblastine 10 mg/m2/D * dacarbazine 375 mg/m2/D

Also known as: VIP/ABVD Arm
VIP/ABVD arm
Radiotherapy consolidationRADIATION

The treatment of Ann-Arbor stage I/II and stage III/IV patients with an initial bulky tumor (diameter ≥ 5 cm) was systematically completed by an irradiation plan. Forty grays were delivered (1,8 gray/day) over four weeks on the involved field.

Also known as: Consolidation treatment
CHOP 21VIP/ABVD arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed untreated PTCL
  • age 18 and 70 years
  • performance status ≤ 2
  • Ann Arbor stage I to IV
  • normal cardiac ventricular ejection fraction over 50%
  • normal hepatic function (asat, ALAT, PAL \< 2.5 ULN)

You may not qualify if:

  • cutaneous form of PTCL
  • previous treatment
  • age \< 18 and \> 70
  • performance status \> 2
  • abnormal cardiac or hepatic functions
  • HIV-, HCV- or HBV- positivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr REMY GRESSIN

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

CHOP protocol

Condition Hierarchy (Ancestors)

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

Study Officials

  • Remy GRESSIN, MD MS

    CHU Grenoble GOELAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

September 2, 2009

Study Start

January 1, 1995

Primary Completion

December 1, 2002

Study Completion

September 1, 2008

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

FR(1)