T-cell LymphomaPhase 2NCT00893516

CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma

A Phase 2 study testing CHOP + CD4 and CHOP in people with T-cell Lymphoma, run by Emergent BioSolutions.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: T-cell Lymphoma
What is being tested?: CHOP + CD4 and CHOP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: No sites listed yet
Study dates: May 2007to Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

study is closed to enrollment

Who cannot join

study is closed to enrollment

About this study

Official title: A Multicentre Open-label Dose Escalation Tiral of Zanolimumab in Combination With CHOP Chemotherapy in Patients With CD4 Positive Non-cutaneous Peripheral T-cell Lymphoma With Nodal Involvement.

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

Conditions: T-cell Lymphoma
Being tested: CHOP + CD4, CHOP
Keywords: non cutaneous peripheral t-cell lymphoma with nodal involvement
Medical subject headings: Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHOP + CD4Biological
CHOPDrug

Study groups in NCT00893516
Study group	Role	What they receive
1	Experimental	CHOP chemo therapy + CD4 therapy Receives: Biological: CHOP + CD4
2	Active comparator	CHOP chemotherapy Receives: Drug: CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Dec 2008

First posted6 May 2009 (estimated)
Study startMay 2007
Primary completionOct 2008
Study completionDec 2008

Why it stopped: Portfolio consolidation.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for T-cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00893516
Sponsor's protocol ID: GEN112
Status last verified: Mar 2024
First submitted: 5 May 2009
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell Lymphoma
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic

All T-cell Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre Open-label Dose Escalation Tiral of Zanolimumab in Combination With CHOP Chemotherapy in Patients With CD4 Positive Non-cutaneous Peripheral T-cell Lymphoma With Nodal Involvement.
ClinicalTrials.gov ID: NCT00893516
Acronym / sponsor ID: GEN112
Conditions: T-cell Lymphoma
Keywords: non cutaneous peripheral t-cell lymphoma with nodal involvement
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Portfolio consolidation.
Enrolment: 5 participants (actual)
Lead sponsor: Emergent BioSolutionsIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Oct 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 6 May 2009 (estimated)
Results: Posted 21 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: CHOP + CD4CHOP chemo therapy + CD4 therapy
2	Active comparator	Drug: CHOPCHOP chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

study is closed to enrollment

Key exclusion criteria (1 listed)

study is closed to enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHOP + CD4	Biological	1
CHOP	Drug	2

Primary outcome

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

Results and safety

Results posted to the registry on 21 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4	0	0
2 CHOP Chemotherapy CHOP	0	0

Primary outcome: Primary Outcome Unavailable

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

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4	0 of 0	0 of 0	Not reported
2 CHOP Chemotherapy CHOP	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): All efforts to obtain data have been exhausted, therefore we have no data available to report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for T-cell Lymphoma

RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell Lymphoma
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHOP + CD4 and CHOP in people with T-cell Lymphoma, run by Emergent BioSolutions.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome Unavailable. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00893516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.