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Für registrierte User stehen verschiedene Download-Dokumente zu den einzelnen Studien zur Verfügung. Dazu können Sie sich im Login-Bereich links auf dieser Seite einloggen.

Studien-Suche:

Alle Studien


Studien: AGMT_NHL-15B |  Ro-CHOP |  AGMT_ALCL1 |  AGMT_MALT-2 |  REMARC |  PTCL 1 |  NHL 7-2008/A |  ML20523_MALT |  NHL-14 |  NHL-01 |  NHL-10 |  NHL-11 |  NHL-12 |  NHL-13 |  NHL-02 |  NHL-03 |  NHL-05 |  NHL-04, 06 und 07 |  NHL-08 |  NHL-09 |  MinT Follow-Up | 

 


AGMT_NHL-15B

Coordinating Investigator: Univ.-Prof. Dr. Ulrich Jäger
Fallzahl: 21
Start: Q1 2017 | Ende: Q2 2020
Status: recruiting


Phase II single-arm \"window-of-opportunity\" study of a combination of obinutuzumab (GA-101) and venetoclax (ABT-199) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Studiendesign

Obinutuzumab will be given i.v. at a dose of 1000 mg on days 1, 8, 15 in cycle 1 and on day 1 of each following cycles. Venetoclax will be given at 800mg daily p.o. One cycle is 21 days.
This combination treatment will be repeated for up to 3 cycles.
Eligible patients will then proceed to stem cell transplantation.
A 9 cycles (27 weeks) maintenance phase with obinutuzumab and venetoclax will be given in patients ineligible for transplant.
The study will have a 6 patient run-in phase to determine safety and to adjust treatment. After 10 patients a futility analysis is planned.
A Data Safety Monitoring Board (DSMB) will review the safety data once the study is opened.

The first response assessment (including PET-CT) will be performed after the first cycle of obinutuzumab + venetoclax and patients with at least stable disease (SD) or better will be given another 2 cycles of therapy and then have assessment after a total of 3 cycles. Patients with complete or partial remission (CR, PR) after 3 cycles of therapy will either go on to transplant or receive 9 further cycles of the combination therapy (if transplant ineligible). In this case assessments will be performed after 6, 9 and 12 cycles.
Patients with progressive disease at any time-point or stable disease after 3 cycles will be taken off study.

Studienziele

Primary objective:
• To evaluate clinical activity and tolerability of obinutuzumab in combination with venetoclax in patients with relapsed/refractory DLBCL

Secondary objectives:
• Safety: Incidence of dose-limiting toxicities of the combination treatment
• Response duration (from first documented response)
• Progression-free survival
• Overall survival
• Ability to proceed to further stem cell transplantation (assessed by number of eligible patients reaching transplant)
• Identification of genetically/biomarker defined subgroups regarding response and survival

Einschlusskriterien (Auszug)

• Patients ≥ 18 years of age
• Diffuse large B-cell lymphoma (DLBCL) with histologically confirmed relapse within 12 months after having achieved a PR or CR with initial R-anthracycline containing therapy, or with refractoriness to initial R-anthracycline containing therapy (not achieving at least a partial response)
• At least one bi-dimensionally measurable lesion on CT scan defined as > 1.5 cm in its longest dimension.
• ECOG Performance Status of 0, 1, or 2
• Adequate organ function

Öffentliche Downloads

AGMT NHL 15 Poster
Poster am OeGHO 2017



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Ro-CHOP

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 15
Start: Q2 2016 | Ende: Q4 2024
Status: recruiting


Phase III multi-center randomized study to compare efficacy and safety of Romidepsin-CHOP (Ro-CHOP) versus CHOP in patients with previously untreated peripheral T-cell lymphoma
by LYSARC: The Lymphoma Academic Research Organisation in Cooperation with AGMT

Studiendesign

This study is an open label, multicenter study. Subjects are randomized at a 1:1 ratio to receive either (arm A) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) or (arm B) romidepsin administered IV at day 1 and day 8 in combination with CHOP administered every 3 weeks for 6 cycles in patients with previously untreated peripheral T-cell lymphoma.

Studienziele

Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by Response Adjudication Committee (RAC).
Secondary objectives are to compare Ro-CHOP between CHOP alone in term of:
• Overall survival
• Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
• Duration of response
• Time to progression
• Time to treatment failure
• Safety
• Quality of Life (QoL)
• Response rates by PTCL histological subtypes
• Response rate by standard prognostic parameters

Einschlusskriterien (Auszug)

1. Males and females of 18 years of age to 80 years of age.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (I - IV):
a. Nodal types:
i. PTCL, not otherwise specified
ii. Angioimmunoblastic T-cell lymphoma
iii. Anaplastic large cell lymphoma, ALK-negative type
b. Extra-nodal types:
i. Enteropathy-associated T-cell lymphoma
ii. Hepato-splenic T-cell lymphoma
iii. Subcutaneous panniculitis-like T-cell lymphoma
iv. Primary cutaneous gamma-delta T-cell lymphoma
v. Primary cutaneous CD8+ aggressive epidermotropic
lymphoma
vi. Primary cutaneous CD4+ small/medium T-cell lymphoma
c. Other non classifiable peripheral T-cell lymphoma
5. ECOG performance status 0, 1 or 2
6. Negative pregnancy test for females of childbearing potential (FCBP)
7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
8. Life expectancy of ≥ 90 days (3 months)

Öffentliche Downloads

Ro-CHOP Poster
Poster am OeGHO 2017



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AGMT_ALCL1

Coordinating Investigator: Prof. Dr. Ulrich Jäger
Fallzahl: 10
Start: Q2 2015 | Ende: Q2 2021
Status: recruiting


A "window of opportunity" trial with Brentuximab Vedotin and Imatinib in patients with relapsed or refractory ALK+ anaplastic large cell lymphoma or patients ineligible for chemotherapy

Studiendesign

This is an open label pilot study of combining BV in a licensed indication with imatinib in patients with ALCL. It is intended as a "window of opportunity" trial in which the study drugs will be given as an initial substitute for conventional chemotherapy with the intention to achieve a remission enabling the patients to proceed to autologous or allogeneic stem cell transplantation, if eligible.
Patients will be included in this trial if they have relapsed or refractory ALK+ ALCL after at least one line of conventional chemotherapy or if they are ineligible for conventional chemotherapy.
Imatinib will be given continuously starting from day 1 of the first cycle at an oral dose of 100mg daily. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle. BV will be given 3 weekly starting on day 1 at a dose of 1.8 mg/kg body weight. In the absence of a dose limiting toyicity (DLT) i.e. haematological toxicity ≥ grade 2, non- haematological toxicity ≥ grade 3, after 3 weeks of therapy, and in the presence of a clinical response (CR or PR) after cycle 1, the BV dose will continue every 3 weeks for 48 weeks. (Figure 2) Dose modifications and stopping rules will be introduced as described in chapter 6. In case of progression at any time during the study the patient will go off trial and receive salvage treatment.

Studienziele

Primary objective:
To determine the safety and tolerability of simultane-ous administration of brentuximab vedotin and imatinib mesylate in substitution of conventional chemotherapeutic treatment.

Secondary objective:
Clinical response rate (ORR, CR, PR) Ability to receive further treatment (stem cell trans-plantation) Progression-free survival and overall survival Identification and assessment of biomarkers

Einschlusskriterien (Auszug)

• Patients ≥ 18 years of age
• ALK+ ALCL
• Histologically confirmed relapse after having achieved a PR or CR with conventional therapy
• Refractoriness to conventional chemotherapy (SD or PD after conventional chemotherapy)
• Not able to receive conventional chemotherapy (e.g. due to comorbidities)
• Adequate organ function
• Written, voluntarily signed informed consent

Öffentliche Downloads

AGMT_ALCL1 Folder
Brief description of the Study

AGMT_ALCL1 Poster
Poster am OeGHO 2017



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AGMT_MALT-2

Coordinating Investigator: Prof. Dr. Markus Raderer
Fallzahl: 46
Start: Q1 2012 | Ende: Q3 2014
Status: completed


Phase II trial of Rituximab plus Lenalidomide in patients with lymphoma of the mucosa associated lymphoid tissue (MALT) type

Studiendesign

This is an open label, phase II study to evaluate the capacity of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) to induce objective responses in patients with MALT lymphoma presenting with measureable disease.

Studienziele

Primary Endpoint:
To evaluate the clinical potential of Rituximab plus Lenalidomide to induce objective/histologic responses in patients with MALT lymphoma

Secondary Endpoint:
To evaluate the safety of Rituximab plus Lenalidomide in this patient population.

Einschlusskriterien (Auszug)

• Histologically verified diagnosis of MALT lymphoma of any localization
• Measurable disease upon diagnosis or first or greater relapse after local therapy (including gastrectomy or any type of surgery or radiation), prior chemotherapy or HP-eradication. In addition, also patients with gastric MALT-lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication will be included in the study. Patients with gastric MALT lymphoma and no evidence of HP-infection (as judged by histology and ultimately serology) may be enrolled immediately)
• Ann Arbor Stage I-IV
• In case of prior treatment with Rituximab, the presence of CD20 on lymphoma cells must have been demonstrated before inclusion in the trial.
• ECOG performance status of 0,1 or 2
• Age > 18 years
• Life expectancy of at least 3 months
• Patient must be able to take aspirin daily as prophylactic anticoagulation (patients intolerant to ASA (may use warfarin or low molecular weight heparin)
• Hematological test results within these ranges:
Absolute neutrophil count > 1000/µl, Platelet count > 60 x 109/L
• Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
• Patient must be willing and able to comply with the protocol for the entire study duration

Female subjects of childbearing potential must:
- understand the potential teratogenic risk to the unborn child
- agree to have a medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL (including females of childbearing potential who commit to complete abstinence)
- agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:

Highly effective methods:
Intrauterine device (IUD)
Hormonal (birth control pills, injections, implants)
Tubal ligation
Partner's vasectomy

Additional effective methods:
Male condom
Diaphragm
Cervical Cap
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia.

- be informed and understand the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy
- understand the need to commence the study treatment as soon as study drug is dispensed following a negative pregnancy test
- understand the need and accepts to undergo pregnancy testing based on the frequency outlined in this protocol
- acknowledge that she understands the hazards and necessary precautions associated with the use of lenalidomide

Male subjects must:
Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a female of childbearing potential.
Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.

All subjects must:
Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
Agree not to share study medication with another person and to return all unused study drug to the investigator



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REMARC

Coordinating Investigator: Prof. Dr. Ulrich Jäger
Fallzahl: 40
Start: Q2 2010 | Ende: Q3 2017
Status: active, not recruiting


Double blind randomized phase III study of Lenalidomide (Revlimid®) maintenance versus Placebo in responding elderly patients with DLBCL and treated with R-CHOP in first line

Studiendesign

This study is a multicenter randomized phase III study of lenalidomide (Revlimid®)
maintenance versus placebo
administered daily for 3 weeks followed by one week rest
for 24 months (26 cycles) in patients responding to R-CHOP/R-COMP for a CD20+ DLBCL.

Patients should have received at least 6 cycles of R-CHOP/R-COMP regimens and up to 8 cycles of
R-CHOP/R-COMP repeated every 2 or 3 weeks according to local preferences.

Studienziele

The primary objective is to determine the benefit estimated by the progression-free
survival associated with lenalidomide maintenance compared to placebo in responding
patients treated in first line with R-CHOP or R-COMP for diffuse large B-cell lymphoma

The secondary objectives are to assess:
- percentage of patients who convert from PR to CR
- efficacy according to the response to R-CHOP/R-COMP
- Overall survival in both groups of patients (with and without lenalidomide maintenance)
- Safety of lenalidomide in maintenance-CHOP/COMP in first line

Einschlusskriterien (Auszug)

For patients registered at the time of initial diagnosis:
• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL)
(WHO classification 2008) including clinical subtypes (primitive mediastinal,
intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade
lymphoma (Follicular, other..) may also be included. Patients with DLBCL
associated with some small cell infiltration in bone marrow may also be included
- Or CD20+ B-cell lymphoma with intermediate features between DLBCL and
Burkitt or with intermediate features between DLBCL and classical Hodgkin
lymphoma
- Or CD20+ Follicular lymphoma grade 3B
- Or CD20+ Agressive B-cell lymphoma unclassifiable
Previously untreated with chemo- or radiotherapy

For patients registered after response evaluation to first line treatment with R-CHOP/R-COMP:
• same as above
• Have reached a CR or PR (Cheson 2007) after first line treatment with at
least 6 cycles of R-CHOP/R-COMP-14 regimens and up to 8 cycles of R-CHOP/R-COMP-21
Previously untreated with Radiotherapy

For all patients:
Aged from 60 to 80 years at time of registration
aaIPI >=1 at time of initial diagnosis



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PTCL 1

Coordinating Investigator: OA Dr. Georg Hopfinger
Fallzahl: 20
Start: Q3 2009 | Ende: Q2 2013
Status: completed


Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin Lymphoma (PTCL)

Studiendesign

Non-randomised, open, Phase I/II in a 3+3 design

Studienziele

Primary objective:
• To determine the maximum tolerated dose of the Lenalidomide, Vorinostat, and Dexamethasone combination

Secondary objectives:
• To determine the safety of the combination regimen, the remission rate of a combination therapy with Lenalidomide, Vorinostat and Dexamethasone, the median progression free survival, overall survival

Einschlusskriterien (Auszug)

• Patients with relapsed PTCL according to WHO classification who have received max. two previous treatments for PTCL or patients with primary refractory PTCL after one previous treatment for PTCL.
• PTCL according to WHO classification as described below:
Peripheral T-cell lymphoma, unspecified (PTCL NOS)
Angioimmunoblastic T-cell lymphoma
Primary systemic, alk negative anaplastic large cell lymphoma (T or null lymphoma)
Enteropathy-type T-cell lymphoma
Subcutaneous panniculitis-like T-NHL
Hepatosplenic  T-cell lymphoma
Extranodal NK/T-cell lymphoma, nasal type
• Age ≥ 18 years.
• Adequate bone marrow function i.e. absolute neutrophile count of > 1000/μl and thrombocytes > 75,000/μl.
• Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)
Life expectancy > 6 months
• ECOG performance status 0-2
• CIRS score ≤ 6
• Ability and willingness to adhere to antithrombotic prophylaxis



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NHL 7-2008/A

Coordinating Investigator: Prim. Univ.-Doz. Dr. Michael A. Fridrik (für Österreich)
Fallzahl: 40
Start: Q3 2009 | Ende: Q3 2017
Status: active, not recruiting


Prospektiv randomisierte Studie zur Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikulärer und anderer niedrig maligner sowie Mantelzell Lymphome

Studiendesign

Prospektiv randomisierte multizentrische Phase III Studie
NUR MEHR FÜR MORBUS WALDENSTRÖM PATIENTEN OFFEN!

Studienziele

Bei den follikulären Lymphomen:
Ermittlung und Vergleich des progressionsfreien Überlebens beider Therapien Bendamustin plus Rituximab und 2 Jahre Rituximab Erhaltungstherapie vs. Bendamustin plus Rituximab und 4 Jahre Erhaltungstherapie

Bei den anderen Lymphomen Immunozytom, Marginalzonen-, Mantelzell:
Ermittlung und Vergleich des progressionsfreien Überlebens beider Therapien Bendamustin plus Rituximab ohne Erhaltungstherapie versus Bendamustin plus Rituximab und 2 Jahre Rituximab Erhaltungstherapie

Einschlusskriterien (Auszug)

Patienten mit histologisch verifiziertem CD20+ C-Zell-Lymphomen folgender Entitäten:
a) Follikuläres Lymphom Grad 1 und 2
b) Lymphozytoplasmatisches Lymphom/Immunozytom (Morbus Waldenström) und kleinzelliges lymphozytisches Lymphom (CLL ohne leukämisches Blutbild)
c) Marginalzonen Lymphom, nodales und generalisiertes (nodal und extranodal)
d) Mantelzell Lymphom

URL-Link

http://www.stil-info.de/

Link zur offiziellen Webseite der StiL-Studiengruppe

Öffentliche Downloads

NHL 7-2008/A Poster
Poster am OeGHO 2016



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ML20523_MALT

Coordinating Investigator: Prof. Dr. Markus Raderer
Fallzahl: 40
Start: Q2 2008 | Ende: Q4 2010
Status: completed


Rituximab und 2 CdA bei Patienten mit fortgeschrittenem oder refraktärem Lymphom des Mukosa-assoziierten Gewebes (MALT-Lymphom). Eine akademische, multizentrische Phase II Studie. (AGMT_MALT)

Studienziele

Primärer Endpunkt: Ansprechrate
Sekundäre Endpunkte: Sicherheit; Progressionsfreies Überleben und Relapse-free Survival

Einschlusskriterien (Auszug)

Histologisch bestätigtes MALT Lymphom mit messbaren Läsionen (Stadium I – IV), nach erstem oder wiederholtem Relapse auf HP-Eradikation, Bestrahlung oder Chemotherapie



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NHL-14

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 80
Start: Q4 2007 | Ende: Q2 2013
Status: completed


Multizentrische Studie über die Kardiotoxizität von R-CHOP (Rituximab, Cyclophosphamid, Doxorubicin, Vincristin und Prednisolon) v. R-COMP (Rituximab, Cyclophosphamid, Liposomalem Doxorubicin, Vincristin und Prednisolon) bei Patienten mit diffus großzelligem B-Zell Lymphom

Studienziele

Primärer Endpunkt: Reduktion der akuten Kardiotoxizität
Sekundäre Endpunkte: Wertigkeit von seriellen NT-proBNP Messungen; Remissionsraten; Unterschiede im Überleben; Event-free Survival und Progressionsfreies Überleben nach 3 und 5 Jahren; Toxizitäten

Einschlusskriterien (Auszug)

Diffus großzelliges B-Zell Lymphom, CD 20 positiv; Messbarer Tumor nach den Internationalen Response Kriterien; alle Stadien

URL-Link

http://www.ncbi.nlm.nih.gov/pubmed/26990931

Link zum Abstract bei PubMed



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NHL-01

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 81
Start: Q4 1987 | Ende: Q1 1991
Status: geschlossen


CEOP-IMVP-Dexa bei aggressiven Non Hodgkin Lymphomen

Studienziele

Primärer Endpunkt: Remissionsrate
Sekundäre Endpunkte: Überleben; Time to Treatment Failure; Time to Relapse; Toxizität

Einschlusskriterien (Auszug)

Unbehandelte aggressive Non Hodgkin Lymphome



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NHL-10

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 25
Start: Q3 2003 | Ende: Q3 2005
Status: geschlossen


Multizentrische Studie über die Machbarkeit einer intensiven Chemo- Immunotherapie bei Patienten Älter als 60 Jahre mit aggressivem B-Zell Lymphom

Studienziele

Primärer Endpunkt: Machbarkeit von CHOP 14 tägig in Kombination mit Rituximab
Sekundäre Endpunkte: Überleben nach 3 und 5 Jahren; Event-free Survival nach 3 und 5 Jahren; Progression-free Survival nach 3 und 5 Jahren; Cause-specific Death; Remissionsrate; Toxizität; Rate der Sekundärmalignome

Einschlusskriterien (Auszug)

Aggressive B-Zell Lymphome, CD 20 Positiv, Alter: 60-75



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NHL-11

Coordinating Investigator: Prof. Dr. Johannes Drach
Fallzahl: 45
Start: Q2 2003 | Ende: Q2 2010
Status: geschlossen


Rituximab plus CHOP plus Thalidomide (R-CHOP-THAL), gefolgt von Thalidomide Erhaltungstherapie bei unbehandeltem Mantelzelllymphom

Studienziele

Primärer Endpunkt: Progressionsfreies Überleben (PFS)
Sekundäre Endpunkte: Sicherheit; Ansprechen und Gesamtüberleben

Einschlusskriterien (Auszug)

Therapienaive Patienten mit histologisch gesichertem CD 20-positivem Mantelzelllymphom



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NHL-12

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 30
Start: Q2 2005 | Ende: Q2 2008
Status: geschlossen


Multizentrische, offene, nicht randomisierte Phase II Studie zur Untersuchung der Wirksamkeit und Verträglichkeit der Konsolidierungstherapie mit 90Yttrium Ibritumomab Tiuxetan (Zevalin®) bei Patienten mit follikulärem Non-Hodgkin Lymphom mit Remission oder Stable Disease nach Primär- oder Sekundärtherapie mit mindestens 6 Zyklen Fludarabin/Mitoxantron mit oder ohne Rituximab

Studienziele

Primärer Endpunkt: Event-free Survival nach 3 und 5 Jahren; Toxizität nach der WHO Skala
Sekundäre Endpunkte: Progression free survival nach 3 und 5 Jahren; Disease-free Survival; Response duration nach 3 und 5 Jahren; Time to next treatment nach 3 und 5 Jahren; Überleben nach 5 Jahren; Bcl-2 Konversion von positiv auf negativ nach Konsolidierungstherapie mit 90Yttrium Ibritumomab Tiuxetan; Verbesserung der Remission 12 Wochen nach der Therapie mit 90Yttrium Ibritumomab Tiuxetan; Rate der Sekundärmalignome

Einschlusskriterien (Auszug)

Follikuläres B-Zell Lymphom (WHO Klassifikation) G I oder II (CD 20 positiv) Stadium III oder IV, CR, CRu, PR, NC nach 6 Induktionstherapien mit Mitoxantron und Fludarabin mit oder ohne Rituximab



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NHL-13

Coordinating Investigator: Prof. Dr. Ullrich Jäger
Fallzahl: 440
Start: Q3 2004 | Ende: Q4 2008
Status: completed


Eine randomisierte Phase III Studie von Rituximab als Erhaltungstherapie versus Beobachtung bei aggressive B-Zell Non-Hodgkin Lymphoma

Studienziele

Primärer Endpunkt: Event-free Survival (EFS)
Sekundäre Endpunkte: Quality of Life; Sicherheit; Gesamtüberleben; Subgruppenanalyse nach histologischen Subtypen

Einschlusskriterien (Auszug)

Diffus großzelliges B-Zell Lymphom oder follikuläres NHL Grad III, CD 20 positiv, Erstlinientherapie mit 8 Zyklen Rituximab und 4 bis 8 Zyklen CHOP-ähnlicher Chemotherapie und CR oder Cru als bestem Response nach Induktionstherapie



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NHL-02

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 53
Start: Q3 1988 | Ende: Q3 1993
Status: geschlossen


Multizentrische randomisierte Therapiestudie CVP versus CVP + α-2-Interferon bei niedrig malignen Non-Hodgkin Lymphomen

Studienziele

Primärer Endpunkt: Remissionsrate
Sekundäre Endpunkte: Überleben; Time to Treatment Failure; Time to Relapse; Toxizität

Einschlusskriterien (Auszug)

Unbehandelte niedrig maligen Non-Hodgkin Lymphome St III-IV



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NHL-03

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 85
Start: Q3 1991 | Ende: Q4 1994
Status: geschlossen


Randomisierte offene Phase III Studie von CEOP/IMVP-Dexa alternierender Chemotherapie plus Filgrastim versus CEOP/IMVP-Dexa alternierender Chemotherapie bei aggressivem Non-Hodgkin Lymphom

Studienziele

Primärer Endpunkt: Inzidenz der febrilen Neutropenien
Sekundäre Endpunkte: Behandlungsverzögerung; Dosisintensität; Dauer der febrilen Perioden; Tage mit Antibiotika; Tage mit Infektion; Überleben; Ansprechrate auf Chemotherapie; Time to Relapse; Time to Treatment Failure

Einschlusskriterien (Auszug)

Unbehandelte aggressive Non-Hodgkin Lymphome



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NHL-05

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 115
Start: Q1 1995 | Ende: Q3 2001
Status: geschlossen


Multizentrische randomisierte Studie über die Primärtherapie hochmaligner Non-Hodgkin Lymphome mit den Polychemotherapien CHOP (Cyclophosphamid, Doxorubicin, Vincristin, Prednisolon) versus CEOP/IMVP-Dexa (Cyclophosphamid, Epirubicin, Vincristin, Prednisolon, Ifosfamid, Methotrexat, VP-16, Dexamethason)

Studienziele

Primärer Endpunkt: 3-Jahres Überleben
Sekundäre Endpunkte: Remissionen; Time to Treatment Failure; Time to Relapse; Toxizität; Therapien nach einem Rezidiv

Einschlusskriterien (Auszug)

Unbehandelte aggressive Non-Hodgkin Lymphome



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NHL-04, 06 und 07

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 116
Start: Q2 1993 | Ende: Q1 2000
Status: geschlossen


2-chlorodesoxyadenosine (2-CdA) in der Therapie niedrig maligner Non-Hodgkin Lymphome (NHL). Amendment IL-2, Amendment Mabthera

Studienziele

Primärer Endpunkt: Remissionsrate
Sekundäre Endpunkte: Überleben; Time to Treatment Failure; Time to Relapse; Toxizität; Dauer der Immunsuppression

Einschlusskriterien (Auszug)

Unbehandelte follikuläre Non Hodgkin Lymphome Stadium III-IV



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NHL-08

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 25
Start: Q3 2003 | Ende: Q4 2005
Status: geschlossen


Multizentrische Studie über die Wertigkeit von Rituximab als Primärtherapie aggressiver B-Zell Lymphome bei Patienten im Alter von 60 Jahren und darunter

Studienziele

Primärer Endpunkt: Machbarkeit der Kombination CEOP/IMVP-Dexa und Rituximab
Sekundäre Endpunkte: Überleben; Event-free Survival und Progressions-freies Überleben nach 3 und 5 Jahren, Cause-specific Death, Remissionsrate, Toxizität, Rate der Sekundärmalignome

Einschlusskriterien (Auszug)

Aggressive B-Zell Lymphome, CD 20 Positiv, Alter: 18-60



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NHL-09

Coordinating Investigator: Doz. Dr. Michael Fridrik
Fallzahl: 25
Start: Q1 2004 | Ende: Q1 2008
Status: geschlossen


Multizentrische Studie über die Kombination von oralem Fludarabin, Mitoxantron und Rituximab Induktionstherapie und Rituximab Erhaltungstherapie bei follikulärem B-Zell Lymphom

Studienziele

Primärer Endpunkt: Konversionsrate der bcl-2 PCR im Blut und Knochenmark
Sekundäre Endpunkte: Verbesserung der Remission durch Rituximab Erhaltung; Überleben; Event-free Survival und Progressions-freies Überleben nach 3 und 5 Jahren; Cause-specific Death; Remissionsrate; Toxizität; Rate der Sekundärmalignome

Einschlusskriterien (Auszug)

Follikuläre Lymphome CD-20 positiv, St III oder IV



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MinT Follow-Up

Coordinating Investigator: Prof. Dr. Jäger/ DSHNHL
Fallzahl: 11
Start: Q1 2008 | Ende: Q2 2008
Status: geschlossen


Follow-up observational study of the randomised intergroup trial of first line treatment for young good-prognosis diffuse large B-Cell non-Hodgkin lymphoma patients with a CHOP-like chemotherapy regiment with or without the anti-CD20 antibody Rituximab (IDEC-C2B8)

Studienziele

Primary end point: TTF (time to treatment failure)
Secondary end points: rate of complete remissions,; rate of primary progressions; tumor control; disease free survival; relapse rate; preogression free, relapse free and overall survival; long term toxicities; second neoplasms

Einschlusskriterien (Auszug)

All patients previously enrolled in the MinT Study



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