Registry of the German CLL Study Group

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

Studienbeginn:
August 2013

Letztes Update:
25.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Leukemia, Large Granular Lymphocytic, Leukemia, Prolymphocytic, Leukemia, Prolymphocytic, B-Cell, Leukemia, Prolymphocytic, T-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
German CLL Study Group

Collaborator:
-

Studienleiter

Michael Hallek, MD
Study Director
German CLL Study Group, Department I of Internal Medicine University Hospital Cologne

Kontakt

Anna-Maria Fink, MD
Kontakt:
Phone: +4922147888220
E-Mail: cllstudie@uk-koeln.de» Kontaktdaten anzeigen

Central Study Office of the German CLL Study Group
Kontakt:
Phone: +4922147888220
E-Mail: cllstudie@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Lutz Jakobasch, MD» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The most frequent primary endpoint in phase III trials of CLL is progression-free survival

(PFS). However, the most important endpoint is overall survival (OS) which is usually a

secondary endpoint in such trials. The outcome after progression is critical and responses to

second and subsequent therapies may differ between the trial arms. Therefore it is essential

to assess OS in addition to PFS. In addition, late toxicities, such as myelodysplastic

syndrome (MDS) or acute myeloid leukemia (AML), Epstein-Barr virus (EBV)-associated

lymphoproliferative disease or Hodgkin's disease, late opportunistic infections and second

malignancies, are increasingly seen and are likely to differ depending on the intensity of

therapy. Moreover, meta-analysis of several phase III trials with long follow-periods are

desirable. Similarly, valid analyses of biological disease characteristics in relation to

outcome are depending on large collections of clinical data with mature follow-up.

The findings of the CLL8 study provide evidence that the addition of rituximab to

chemotherapy with Fludarabine and Cyclophosphamide (FC) may prolong survival of patients with

CLL. However, it also opens the question about whether applying such therapy might cause

certain late toxicities and whether it improves longterm survival for patients with CLL.

Moreover the outcome of subsequent therapies after various first line treatments with

Fludarabine (F), FC, Bendamustine and Rituximab (BR) or Fludarabine, Cyclophosphamide and

Rituximab (FCR) amongst others outside of clinical trials needs to be investigated further.

Recently published phase III trials in CLL showed median observation times ranging from 22 to

41 months, but most of the trials report observation times around 2 years only. For most of

the phase III trials of the German CLL Study Group (GCLLSG) great efforts were made to

implement an extended follow up in these trials, but due to administrative reasons the follow

up is limited to at most 8 years. This registry should enable the collection of data of the

entire course of diseases in- and outside of clinical trials.

Besides CLL other related rare lymphoproliferative malignancies will be included in this

registry. On the one hand for historical on the other hand for clinical reasons these

diseases are close to CLL and information about them should be gathered as best as possible.

Only limited information is available for patients with SLL, B-PLL, T-PLL, T/NK-LGL, HCL and

Richter's transformation. They carry orphan disease status and long-term follow-up data is

urgently needed.

To our knowledge there are no comparable registries for patients with CLL, B-PLL, T-PLL, SLL,

T/NK-LGL, HCL or Richter's transformation. In order to understand and gain greater insight

into the biology, the response to treatment and the outcome of very rare diseases it is

extremely important to gather structured information about the patients and their disease

centrally.

Ein-/Ausschlusskriterien

Inclusion Criteria (all must apply)

1. Confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's

transformation

2. 18 years of age or older

3. Signed, written informed consent

4. Presence of one or more of the following disease situations:

- Newly diagnosed patients without treatment indication (eligible for watch and

wait Approach Treatment within a clinical trial according to the AMG or status

post participation in a clinical Trial)

- Treatment with standard therapies approved for the eligible entities or status

post treatment (outside of clinical trials)

- Referral for evaluation the indication for HSCT

- Relapsed disease status (even if first diagnosis was prior to activation of the

registry)

Exclusion Criteria

1. Patients without confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK- LGL, HCL or

Richter's transformation

2. Cerebral dysfunction, legal incapacity

Studien-Rationale

Primary outcome:

1. Overall Survival (Time Frame - from date of registry entry until date of death, up to 12 years):
Overall survival will be measured from date of registry entry until date of death

Quelle: ClinicalTrials.gov

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