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Registry of the German CLL Study Group (CLL-Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863692
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
German CLL Study Group

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

Condition or disease
CLL SLL HCL Richter´s Transformation Leukemia, Prolymphocytic, B-Cell Leukemia, Prolymphocytic, T-Cell T-LGL Leukemia NK-LGL Leukemia

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 25 Years
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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025





Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863692


Contacts
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Contact: Christian Maurer, MD +4922147888220 cllstudie@uk-koeln.de
Contact: Central Study Office of the German CLL Study Group +4922147888220 cllstudie@uk-koeln.de

Locations
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Germany
BAG Freiberg-Richter, Jacobasch, Wolf, Illmer Recruiting
Dresden, Sachsen, Germany
Contact: Lutz Jakobasch, MD         
Sponsors and Collaborators
German CLL Study Group
Investigators
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Study Director: Michael Hallek, MD German CLL Study Group, Department I of Internal Medicine University Hospital Cologne
Additional Information:
Publications of Results:
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Responsible Party: German CLL Study Group
ClinicalTrials.gov Identifier: NCT02863692    
Other Study ID Numbers: CLL-Registry
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by German CLL Study Group:
CLL
B-PLL
T-PLL
SLL
T-NK-LGL
HCL
Richter´s Transformation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Large Granular Lymphocytic
Leukemia, Prolymphocytic
Leukemia, Prolymphocytic, B-Cell
Leukemia, Prolymphocytic, T-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, T-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell