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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.

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Studien: CLL9 |  CLL-8/A Mabtenance |  CLL-6 BendAlem |  CLL-5 RevliRit |  CLL-4 CHAIROS |  CLL-ic NHL II |  CLL-ic |  Flusalem | 

 


CLL9

Coordinating Investigator: Prim. Univ.-Prof. Dr. Richard Greil
Fallzahl: 10
Start: Q3 2012 | Ende: Q3 2014
Status: completed


Fludarabine/Rituximab combined with escalating doses of Lenalidomide in untreated chronic lymphocytic leukemia (CLL) – a dose-finding study with escalating starting dose of Lenalidomide and concomitant evaluation of safety and efficacy

Studiendesign

This is a non-randomized, multicenter, open-label, single arm phase II trial in patients with previously untreated CD20-positive CLL.
Eligible patients will receive lenalidomide with a backbone of FR for 6 cycles. Lenalidomide will be increased by dose steps of 5 mg every 28 days in the absence of limiting toxicity. If dose limiting toxicity ensues the patients will be treated with last tolerable dose for the remainder of the 6 treatment cycles.
The first 5 patients will start with dose level 5 mg lenalidomide and further escalating dose.
After the fifth patient is included in the study, enrolment will be interrupted until this patient has finished his first treatment cycle. A safety board will evaluate the toxicities of the first 5 patients. If there are more than 2 patients experiencing a DLT in the first treatment cycle, the starting dose will not be escalated and further 5 patients will be enrolled with a starting dose of 5 mg lenalidomide. If only 2 or less patients experience a DLT in the first treatment cycle, the next 5 patients will start the treatment with 10 mg lenalidomide.

Studienziele

Objectives of the Study
Primary endpoint:
•  Tolerability of escalated starting dose

Secondary endpoints:
•  Establishment of maximal tolerated dose (MTD) of lenalidomide in combination with FR
•  Time to MTD
•  Safety profile of the FRL combination
•  Response rates in all phases by 4-colour flow cytrometric MRD analysis
•  Risk factor analysis (FISH cytogenetics, CD38/ZAP-70 expression, mutation status)
•  Longitudinal definition of T cell subsets (including prognostic EM T cells and Treg cells) +/- PD1

Einschlusskriterien (Auszug)

•  Signed written informed consent
•  Male or female ≥ 18 years of age
•  CLL (as determined by CD23+, CD5+, CD19+)
•  Treatment indication as defined by the NCIWorkshop criteria (see appendix 5 and reference 10)
•  ECOG ≤ 2
•  No previous treatment of the CLL by chemotherapy, radiotherapy (except localized radiotherapy of 1 lymphatic area) or immunotherapy
•  Life expectancy > 6 months (except prognosis due to high risk CLL)

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) details see appendix 6
  •  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. Fibronectin Cell Binding Peptide (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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CLL-8/A Mabtenance

Coordinating Investigator: Prof. Dr. Richard Greil, Doz. Dr. Alexander Egle
Fallzahl: 256
Start: Q4 2009 | Ende: Q4 2015
Status: active, not recruiting


MABTENANCE: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Chronic Lymphocytic Leukemia

Studiendesign

Phase III, randomized CLL Patients with a PR or CR after a Rituximab containing induction treatment will be randomized to treatment with Rituximab every 3 months for 24 months or observation for 24 months

Studienziele

Primary Endpoint: Progression free survival

Secondary Endpoints: MRD-progression free survival, conversion rate to MRD negative, median MRD levels, conversion rate to CR, effect of MRD levels on clinical PFS and OS, Event free survival, Time to next treatment, overall survival, safety, benefit according to cytogenetic risk group

Einschlusskriterien (Auszug)

• B-CLL
• ECOG performance status 0-2
• Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
• Patient must be in complete remission or partial remission after an induction treatment containing rituximab
• ANC (absolute neutrophil count) ≥ 1.0 x 109/L
• Life expectancy > 6 months

URL-Link

http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30045-X/abstract

Link zum Abstract in The Lancet Haematology



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CLL-6 BendAlem

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 20
Start: Q1 2009 | Ende: Q2 2013
Status: completed


Bendamustin + Alemtuzumab bei vorbehandelter chronisch lymphatischer Leukämie (CLL) – eine Phase I/II Studie mit konkomitanter Evaluierung der Sicherheit und Wirksamkeit

Studiendesign

Non-randomized phase I/II Gehan design.

Studienziele

Primärer Endpunkt: Complete Response Rate
Sekundäre Endpunkte: Sicherheit; Analyse biomarker; Quality of Life

Einschlusskriterien (Auszug)

Vorbehandeltes CLL mit Behandlungsindikation gemäß NCI Kriterien; Alter 18 Jahre und älter; ECOG 0 -2



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CLL-5 RevliRit

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 45
Start: Q3 2008 | Ende: Q1 2011
Status: completed


Fludarabine/ Rituximab in Kombination mit Lenalidomide gefolgt von Rituximab/ Lenalidomid bei unbehandelter chronisch lymphatischer Leukämie – eine Dosisfindungsstudie mit konkomitanter Auswertung der Sicherheit und Wirksamkeit

Studienziele

Primärer Endpunkt: Bestimmung der MTD;
Sekundäre Endpunkte: Sicherheit; Wirksamkeit; Ansprechraten; Risikofaktoren und Quality of Life

Einschlusskriterien (Auszug)

Therapiebedürftige, unbehandelte B-CLL, Alter 18 Jahre und älter, ECOG Status 0 - 2



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CLL-4 CHAIROS

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 40
Start: Q4 2005 | Ende: Q4 2007
Status: completed


FCR Chemoimmuno Induktionstherapie gefolgt von FR und Rituximab Erhaltungstherapie bei chemonaiven Patienten mit B-CLL – Eine Phase II Studie

Studienziele

Primärer Endpunkt: Complete Response Rate
Sekundäre Endpunkte: Klinische Wirksamkeit; Sicherheit; Zytogenetisches und molekulares Risikoprofil

Einschlusskriterien (Auszug)

Unbehandelte B-CLL mit Behandlungsindikation gemäß NCI Kriterien, Alter 18 Jahre und größer, ECOG 0 - 2



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CLL-ic NHL II

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 14
Start: Q3 1999 | Ende: Q1 2003
Status: geschlossen


Fludarabine (oral)/Interferon- Induktions Therapie und Interferon- Erhaltungstherapie bei Patienten mit B-CLL

Studienziele

Primärer Endpunkt: Response rate
Sekundäre Endpunkte: Remissionsdauer; Toxizität; Quality of Life; Immunstatus

Einschlusskriterien (Auszug)

Unbehandelte und vorbehandelte Patienten mit B-CLL oder immunozytischen Lymphomen



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CLL-ic

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 120
Start: Q3 1994 | Ende: Q3 1997
Status: geschlossen


Fludarabin- Induktions/Interferon- Erhaltungstherapie primär unbehandelter und erstrelapsierender chronisch lymphatischer Leukämien und immunocytischer NHL

Studienziele

Primärer Endpunkt: Remissionsrate, Time to Progression
Sekundäre Endpunkte: Überleben; Toxizität; Sekundärneoplasien

Einschlusskriterien (Auszug)

B-CLL oder immunocytisches Lymphom unbehandelt oder 1. Rezidiv, 20-70 Jahre



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Flusalem

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 28
Start: Q1 2004 | Ende: Q4 2007
Status: geschlossen


Subkutanes MabCampath® (Alemtuzumab) und orales Fludara® (Fludarabinephosphate) in der Behandlung primär refraktärer oder erstrelapsierter chronisch lymphozytischer Leukämie: Eine Pilotstudie (FLUSALEM) zur Bestimmung der Sicherheit und Wirksamkeit.

Studienziele

Primärer Endpunkt: Sicherheit; Verträglichkeit und Ansprechraten
Sekundäre Endpunkte: Time to Retreatment; Time to Progression; Gesamtüberleben; Quality of Life

Einschlusskriterien (Auszug)

B-CLL mit Indikation für Zweit- oder Drittlinientherapie



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