See C4
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's T-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
event-free survival at 3 yr
Secondary outcome
overall survival at 3 yr
progression-free survival at 3 yr
responses (%CR and %PR), at the end of therapy
time to progression
relation CD52 expression and response-rate
safety addition of alemtuzumab to CHOP measured by incidences of infections
Background summary
see C4
Study objective
See C4
Study design
Intergroup design, multicenter randomised fase III study
Intervention
The addition of alemtuzumab to standard CHOP chemotherapy, see above
Study burden and risks
standard treatment consists of CHOP, given at 2 weeks interval. The addition of
alemtuzumab requires subcutaneous injections at day 1 and 2. The first 2
injections can cause transient painful infiltrates. The risk on infections is
increased requiring additional antibiotics and blood controls, especially
related to CMV re-activations. Blood products need to be irradiated.
Robert Koch str. 42
Goettingen D-37075
DE
Robert Koch str. 42
Goettingen D-37075
DE
Listed location countries
Age
Inclusion criteria
1. Age: 61 - 80 years
2. All risk groups, including stage I with bulk (>= 7.5 cm) and stages II to IV, except stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60
3. Confirmed histological diagnosis of peripheral T cell NHL of the following types:
peripheral T-cell lymphoma PTCL-NOS
Angioimmunoblastic T cell lymphoma
intestinal T/NK-cell lymphoma (± enteropathy)
hepatosplenic lymphoma
subcutaneous panniculitis-like PTCL (gamma-delta T-cell lymphoma)
4. Performance status: ECOG 0 - 2 (Karnofsky index: 60 - 100%). ECOG 3 is acceptable, if lymphoma related.
5. Measurable disease
6. written consent of the patient
Exclusion criteria
1. Stage I with IPI 0 and without bulk
2. Already initiated lymphoma therapy
3. Serious accompanying disorder or impaired organ function, in particular:
- severe cardiac dysfunction (NYHA class II-IV; LVEF <45%)
- severe pulmonary dysfunction (FeV1<50% or DC <50%)
- Renal: creatinine >2 times the upper reference limit, unless related to NHL
- Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
- Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
4. Platelets <100 000/mm3, leukocytes <2500/mm3
5. Bone marrow involvement >25%
6. Known hypersensitivity to the medications to be used, especially murine or
chimeric antibodies
7. primary leukemic lymphoma
8. Known HIV-positivity
9. Active hepatitis infection, active CMV infection, active systemic fungal infection,
active infection with mycobacterium tuberculosis or atypical tuberculosis
10. Suspicion that patient compliance will be poor
11. Simultaneous participation in any other study protocol
12. Prior chemo- or radiotherapy for malignancy
13. Other concomitant malignant disease (history of active cancer during the past 5
years, except basal carcinoma of the skin or stage 0 cervical carcinoma)
14. Non-conformity to eligibility criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-000821-23-NL |
| CCMO | NL18527.042.08 |