NCT00893516

Brief Summary

Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2007

Status
terminated

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

May 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
12 years until next milestone

Results Posted

Study results publicly available

April 21, 2021

Completed
Last Updated

April 9, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

May 5, 2009

Results QC Date

March 30, 2021

Last Update Submit

March 14, 2024

Conditions

T-cell Lymphoma

Keywords

non cutaneous peripheral t-cell lymphoma with nodal involvement

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Unavailable

    All efforts to obtain data have been exhausted, therefore we have no data available to report.

Study Arms (2)

1

EXPERIMENTAL

CHOP chemo therapy + CD4 therapy

Biological: CHOP + CD4

2

ACTIVE COMPARATOR

CHOP chemotherapy

Drug: CHOP

Interventions

CHOP + CD4BIOLOGICAL
1
CHOPDRUG
2

Eligibility Criteria

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

You may qualify if:

  • study is closed to enrollment

You may not qualify if:

  • study is closed to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

All efforts to obtain data have been exhausted, therefore we have no data available to report.

Results Point of Contact

Title
Clinical Development Representative
Organization
Emergent Biosolutions
ctgov@ebsi.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

May 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

April 9, 2024

Results First Posted

April 21, 2021

Record last verified: 2024-03