Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

Extranodal NK/T-cell Lymphoma Clinical Trial

— A-CHOP-14  

Official title:

Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00725231
• Other study ID #: DSHNHL 2006-1B / ACT-2
• Secondary ID: BMBF GFVT 010147
• Status: Recruiting
• Phase: Phase 3
• First received: July 25, 2008
• Last updated: May 4, 2012
• Start date: February 2008
• Est. completion date: March 2014

Study information

• Verified date: May 2012
• Source: University of Göttingen
• Contact: Lorenz H Trümper, MD
• Phone: +49 551 398535
• Email: lorenz.truemper[@]med.uni-goettingen.de
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 61 Years to 80 Years

Eligibility

Inclusion Criteria:

• all risk groups of peripheral T cell lymphoma

• performance status ECOG 0-2

• written consent

• measurable disease

Exclusion Criteria:

• stage I N without bulky disease

• already initiated treatment

• serious accompanying disorder or impaired organ function

• bone marrow involvement >25%

• HIV positivity

• leukemic manifestation of lymphoma

• simultaneous participation in another trial

• platelets < 100 000/ mm, leukocytes < 2500 /mm

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioimmunoblastic Lymphadenopathy
• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma, Unspecified

Intervention

Biological:
• alemtuzumab
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles

Drug:
• chemotherapy
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Locations

Country	Name	City	State
Germany	University of Göttingen	Göttingen	Lower Saxony

Sponsors (3)

Lead Sponsor	Collaborator
University of Göttingen	German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival		3 years	No
Secondary	Rate of complete and partial remissions		4 months after inclusion	No
Secondary	treatment related deaths		time of occurence	Yes
Secondary	Overall survival		@ 3 years	Yes
Secondary	protocol adherence		4 months of treatment	Yes
Secondary	immune reconstitution after alemtuzumab CHOP		3 years	Yes

External Links

•   main site of German lymphoma trial groups