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Clinical Trials/EUCTR2010-019587-36-DE
EUCTR2010-019587-36-DE
Active, not recruiting
Phase 1

Improvement of outcome and reduction of toxicity in elderly patients with CD20+ aggressive B-cell lymphoma by an optimised schedule of the monoclonal antibody rituximab, substitution of conventional by liposomal vincristine and FDG-PET based reduction of therapy in combination with vitamin D substitution - OPTIMAL>60/DR.CHOP

niversität des Saarlandes0 sites1,152 target enrollmentApril 19, 2011
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ConditionsDiffuse large B-cell lymphomaMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsMabthera 100 mgMabthera 500 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diffuse large B-cell lymphoma
Sponsor
niversität des Saarlandes
Enrollment
1152
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 19, 2011
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversität des Saarlandes

Eligibility Criteria

Inclusion Criteria

  • •Elderly patients (61\-80 years) with newly diagnosed aggressive CD20\+ B\-NHL. All risk groups with good general condition (ECOG 0\-2\) without majour accompanying diseases after patient's information and written patient's informed consent
  • •Please note: only favourable patients (IPI \= 1 (age)) without bulk can be included as recruitment goal for less favourable patients has been reached.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1152

Exclusion Criteria

  • •Already initiated lymphoma therapy ; Serious accompanying disorder or impaired organ function; Platelets \<75 000/mm3, leukocytes \<2 500/mm3; Known hypersensitivity to the medications to be used; Known HIV\-positivity; Chronic active hepatitis; Poor patient compliance; Simultaneous participation in other treatment studies or in another clinical trial; Prior chemo\- or radiotherapy, long\-term use of corticosteroids or anti\-neoplastic drugs for previous disorder; CNS involvement of lymphoma; Persistent neuropathy grade \=2 (unless due to lymphoma involvement) ;Pregnancy or breast\-feeding women Persons depending on sponsor or investigator
  • •Persons from highly protected groups.

Outcomes

Primary Outcomes

Not specified

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