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

Peripheral T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806337
• Other study ID #: DSHNHL-2003-1
• Secondary ID: German High Grad
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2013
• Last updated: March 6, 2013
• Start date: July 2003
• Est. completion date: February 2011

Study information

• Verified date: March 2013
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2011
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma

Intervention

Drug:
• Alemtuzumab
Consolidation after CHOP induction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	rate of complete remissions		at week 24 after initiation	No
Secondary	Overall survival		5 years	No