Registry of the German CLL Study Group

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Brief Title

Registry of the German CLL Study Group

Official Title

Registry of the German CLL Study Group Long Term Follow-up of Patients With CLL, B-PLL, T-PLL, SLL,T or NK-LGL, HCL and Richter's Transformation

Brief Summary

      Long term follow-up of patients with chronic lymphocytic leukemia (CLL), B-prolymphocytic
      leukemia (B-PLL), T-cell prolymphocytic leukemia (T-PLL), Small lymphocytic lymphoma (SLL),
      T/Natural Killer large granular lymphocyte leukemia (T or NK-LGL), Hairy cell leukemia (HCL)
      and Richter's transformation
    

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Overall Survival


Condition

CLL



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

8000

Start Date

August 2013

Completion Date

December 2025

Primary Completion Date

December 2025

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Hallek, MD, +4922147888220, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02863692

Organization ID

CLL-Registry


Responsible Party

Sponsor

Study Sponsor

German CLL Study Group


Study Sponsor

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


Verification Date

April 2022