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Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14)

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
alemtuzumab
chemotherapy
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma, Unspecified focused on measuring T cell lymphoma

Eligibility Criteria

61 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of GöttingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Chemotherapy with dose dense CHOP-14, 6 cycles

Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles

Outcomes

Primary Outcome Measures

Event free survival

Secondary Outcome Measures

Rate of complete and partial remissions
treatment related deaths
Overall survival
protocol adherence
immune reconstitution after alemtuzumab CHOP

Full Information

First Posted
July 25, 2008
Last Updated
May 4, 2012
Sponsor
University of Göttingen
Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group
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1. Study Identification

Unique Protocol Identification Number
NCT00725231
Brief Title
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP
Acronym
A-CHOP-14
Official Title
Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group, Nordic Lymphoma Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma
Keywords
T cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Chemotherapy with dose dense CHOP-14, 6 cycles
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Other Intervention Name(s)
monoclonal anti CD52 antibody
Intervention Description
Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
chemotherapy cylcophosphamide, hydroxyldaunorubicin
Intervention Description
dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF
Primary Outcome Measure Information:
Title
Event free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of complete and partial remissions
Time Frame
4 months after inclusion
Title
treatment related deaths
Time Frame
time of occurence
Title
Overall survival
Time Frame
@ 3 years
Title
protocol adherence
Time Frame
4 months of treatment
Title
immune reconstitution after alemtuzumab CHOP
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz H Trümper, MD
Phone
+49 551 398535
Ext
8535
Email
lorenz.truemper@med.uni-goettingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald G Wulf, MD
Phone
+49 551 396303
Ext
6303
Email
gwulf@med.uni-goettingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz H Trümper, MD
Organizational Affiliation
University of Göttingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Göttingen
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37099
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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