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

NCT01806337 | Completed Phase 2 DMC

• 2 other identifiers: DSHNHL-2003-1German High Grade Lymphoma SG
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peripheral T-Cell Lymphoma

Keywords

peripheral T cell lymphoma; alemtuzumab; consolidation

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• rate of complete remissions

  at week 24 after initiation

• Overall survival

  5 years

Study Arms (1)

Alemtuzumab, antibody

EXPERIMENTAL

alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

Consolidation after CHOP induction

Also known as: MabCampath

Alemtuzumab, antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lorenz Truemper

  German High Grade Non Hodgkin´s Lymphoma Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 7, 2013
• Study Start: July 1, 2003
• Primary Completion: July 1, 2006
• Study Completion: February 1, 2011
• Last Updated: March 7, 2013

Record last verified: 2013-03