CHO(E)P-14 Followed by Alemtuzumab Consolidation in Perip... | NCT01806337

Studies
CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

NCT01806337

Sponsor

University of Göttingen

Status

Completed

Last Update Posted

Mar 7, 2013Estimated

Enrollment

41Actual

Phase

Phase 2

Conditions

Peripheral T-Cell Lymphoma

Interventions

Alemtuzumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
German High Grade Lymphoma SG	Other Identifier	DSHNHL

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jul 2006Actual

Completion Date

Feb 2011Actual

First Submitted Date

Feb 25, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2013

Last Update Posted Date

Mar 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Detailed Description

Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alemtuzumab, antibody	Experimental	alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg	Drug: Alemtuzumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alemtuzumab	Drug	Consolidation after CHOP induction	Alemtuzumab, antibody

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy	A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab	average of 24 weeks (treatment duration)

Secondary Outcomes

Measure	Description	Time Frame
rate of complete remissions		at week 24 after initiation
Overall survival		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all risk groups in international prognostic index
diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
written consent of the patient
Declaration of center participation

Exclusion Criteria:

Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
Serious accompanying disorder or impaired organ function
bone marrow involvement>25%
Known hypersensitivity to medications to be used
Know HIV-positivity
Active hepatitis infection, active CMV infection, prior florid tuberculosis
floride systemic infections
suspicion that patient compliance will be poor
Simultaneous participation in any the study protocol
prior chemo-or radiotherapy for malignancy
other concomitant malignant disease
Pregnancy or lactation period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lorenz Truemper	German High Grade Non Hodgkin´s Lymphoma Study Group	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D016411	Lymphoma, T-Cell, Peripheral

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074323	Alemtuzumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided