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

This study has been terminated.

(Portfolio consolidation.)

Sponsor:

Information provided by (Responsible Party):

Emergent BioSolutions

ClinicalTrials.gov Identifier:

NCT00893516

First received: May 5, 2009

Last updated: February 25, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 5, 2009
Last Updated Date	February 25, 2013
Start Date ^ICMJE	May 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00893516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CD4 in Combination With CHOP in Treating Non-cutaneous Peripheral TCell Lymphoma
Official Title ^ICMJE	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.
Brief Summary	Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	T-cell Lymphoma
Intervention ^ICMJE	Biological: CHOP + CD4 Drug: CHOP
Study Arm (s)	Experimental: 1 CHOP chemo therapy + CD4 therapy Intervention: Biological: CHOP + CD4 Active Comparator: 2 CHOP chemotherapy Intervention: Drug: CHOP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	5
Completion Date	December 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: study is closed to enrollment Exclusion Criteria: study is closed to enrollment
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00893516
Other Study ID Numbers ^ICMJE	GEN112
Has Data Monitoring Committee	No
Responsible Party	Emergent BioSolutions
Study Sponsor ^ICMJE	Emergent BioSolutions
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Emergent BioSolutions
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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