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

• Sponsor: Emergent BioSolutions (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00893516
• Collaborator: (none)
• Enrollment: 5
• Arms: 2
• Duration (Months): 19.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
T-cell Lymphoma	Biological: CHOP + CD4; Drug: CHOP	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 CHOP chemo therapy + CD4 therapy	Biological: CHOP + CD4
Active Comparator: 2 CHOP chemotherapy	Drug: CHOP

Outcome Measures

Primary Outcome Measures

1. Primary Outcome Unavailable []

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• study is closed to enrollment

Exclusion Criteria:

• study is closed to enrollment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Emergent BioSolutions

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emergent BioSolutions
• ClinicalTrials.gov Identifier: NCT00893516
• Other Study ID Numbers: GEN112
• First Posted: May 6, 2009
• Last Update Posted: May 3, 2022
• Last Verified: May 1, 2022

• Keywords provided by Emergent BioSolutions: non cutaneous peripheral t-cell lymphoma with nodal involvement
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

Participant Flow

Pre-assignment Detail	All efforts to obtain data have been exhausted, therefore we have no data available to report.

Arm/Group Title	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4	2 CHOP Chemotherapy CHOP
Arm/Group Description	CHOP chemo therapy + CD4 therapy CHOP + CD4	CHOP chemotherapy CHOP
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4	2 CHOP Chemotherapy CHOP	Total
Arm/Group Description	CHOP chemo therapy + CD4 therapy CHOP + CD4	CHOP chemotherapy CHOP	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4	2 CHOP Chemotherapy CHOP
Arm/Group Description	CHOP chemo therapy + CD4 therapy CHOP + CD4	CHOP chemotherapy CHOP
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	All efforts to obtain data have been exhausted, therefore we have no data available to report.
Arm/Group Title	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4		2 CHOP Chemotherapy CHOP
Arm/Group Description	CHOP chemo therapy + CD4 therapy CHOP + CD4		CHOP chemotherapy CHOP
All Cause Mortality
	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4		2 CHOP Chemotherapy CHOP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4		2 CHOP Chemotherapy CHOP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1 CHOP Chemo Therapy + CD4 Therapy CHOP + CD4		2 CHOP Chemotherapy CHOP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.