CLLCLL-RegistryNCT02863692
Registry of the German CLL Study Group
An observational study of CLL and SLL, run by German CLL Study Group at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 8,000 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Dec 2026
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
Who may be able to join
- Confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
- 18 years of age or older
- Signed, written informed consent
- 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)
Who cannot join
- Patients without confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK- LGL, HCL or Richter's transformation
- Cerebral dysfunction, legal incapacity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
BAG Freiberg-Richter, Jacobasch, Wolf, Illmer
Dresden, Saxony
Lutz Jakobasch, MD
About this study
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
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
Read the 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.
- Conditions
- CLL, SLL, HCL, Richter´s Transformation, Leukemia, Prolymphocytic, B-Cell, Leukemia, Prolymphocytic, T-Cell
- Keywords
- CLL, B-PLL, T-PLL, SLL, T-NK-LGL, HCL, Richter´s Transformation
- Medical subject headings
- Leukemia, Prolymphocytic, B-Cell, Leukemia, Prolymphocytic, T-Cell, Leukemia, Large Granular Lymphocytic
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival will be measured from date of registry entry until date of death
Measured: from date of registry entry until date of death, up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CLLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- German CLL Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Hallek, MD, Study director, German CLL Study Group, Department I of Internal Medicine University Hospital Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863692
- Sponsor's protocol ID
- CLL-Registry
- Acronym
- CLL-Registry
- Status last verified
- Dec 2025
- First submitted
- 26 Feb 2015
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kutsch N, Giza A, Robrecht S, Stumpf J, Federhen A, Stoltefuss A, Vehling-Kaiser U, Koenigsmann M, Tausch E, Schneider C, Stilgenbauer S, Illmer T, Schlag R, Dorfel S, Gaska T, Kiehl M, Muller-Hagen S, Moorahrend E, Linde H, Schlenska-Lange A, von Tresckow J, Fischer K, Eichhorst B, Hallek M, Fink AM. Fludarabine, cyclophosphamide, and rituximab as first-line treatment in patients with chronic lymphocytic leukemia: A long-term analysis of the German CLL Study Group (GCLLSG) registry. Eur J Haematol. 2024 Aug;113(2):235-241. doi: 10.1111/ejh.14220. Epub 2024 May 1.
PubMed 38693677Furstenau M, Giza A, Stumpf T, Robrecht S, Maurer C, Linde H, Jacobasch L, Dorfel S, Aldaoud A, von Tresckow J, Koenigsmann M, Gaska T, Kaiser U, Harich HD, Fischer K, Eichhorst B, Hallek M, Fink AM. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia. Am J Hematol. 2021 Dec 1;96(12):E457-E460. doi: 10.1002/ajh.26363. Epub 2021 Oct 8. No abstract available.
PubMed 34591989von Tresckow J, Heyl N, Robrecht S, Giza A, Aldaoud A, Schlag R, Klausmann M, Linde H, Stein W, Schwarzer A, Fischer K, Cramer P, Eichhorst B, Hallek M, Fink AM. Treatment with idelalisib in patients with chronic lymphocytic leukemia - real world data from the registry of the German CLL Study Group. Ann Hematol. 2023 Nov;102(11):3083-3090. doi: 10.1007/s00277-023-05314-2. Epub 2023 Jun 26.
PubMed 37358640
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02863692
- Acronym / sponsor ID
- CLL-Registry / CLL-Registry
- Conditions
- CLL, SLL, HCL, Richter´s Transformation, Leukemia, Prolymphocytic, B-Cell, Leukemia, Prolymphocytic, T-Cell
- Keywords
- CLL, B-PLL, T-PLL, SLL, T-NK-LGL, HCL, Richter´s Transformation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- German CLL Study GroupUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 25 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
Key inclusion criteria (8 listed)
- Confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
- 18 years of age or older
- Signed, written informed consent
- Presence of one or more of the following disease situations:
Key exclusion criteria (2 listed)
- Patients without confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK- LGL, HCL or Richter's transformation
- Cerebral dysfunction, legal incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 38693677Kutsch N, Giza A, Robrecht S, Stumpf J, Federhen A, Stoltefuss A, Vehling-Kaiser U, Koenigsmann M, Tausch E, Schneider C, Stilgenbauer S, Illmer T, Schlag R, Dorfel S, Gaska T, Kiehl M, Muller-Hagen S, Moorahrend E, Linde H, Schlenska-Lange A, von Tresckow J, Fischer K, Eichhorst B, Hallek M, Fink AM. Fludarabine, cyclophosphamide, and rituximab as first-line treatment in patients with chronic lymphocytic leukemia: A long-term analysis of the German CLL Study Group (GCLLSG) registry. Eur J Haematol. 2024 Aug;113(2):235-241. doi: 10.1111/ejh.14220. Epub 2024 May 1.
- Background: PubMed 34591989Furstenau M, Giza A, Stumpf T, Robrecht S, Maurer C, Linde H, Jacobasch L, Dorfel S, Aldaoud A, von Tresckow J, Koenigsmann M, Gaska T, Kaiser U, Harich HD, Fischer K, Eichhorst B, Hallek M, Fink AM. Second primary malignancies in treated and untreated patients with chronic lymphocytic leukemia. Am J Hematol. 2021 Dec 1;96(12):E457-E460. doi: 10.1002/ajh.26363. Epub 2021 Oct 8. No abstract available.
- Derived from this study: PubMed 37358640von Tresckow J, Heyl N, Robrecht S, Giza A, Aldaoud A, Schlag R, Klausmann M, Linde H, Stein W, Schwarzer A, Fischer K, Cramer P, Eichhorst B, Hallek M, Fink AM. Treatment with idelalisib in patients with chronic lymphocytic leukemia - real world data from the registry of the German CLL Study Group. Ann Hematol. 2023 Nov;102(11):3083-3090. doi: 10.1007/s00277-023-05314-2. Epub 2023 Jun 26.
- Click here for more information about this study: Registry of the German CLL Study GroupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Hallek, MD study director
German CLL Study Group, Department I of Internal Medicine University Hospital Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLL and SLL, run by German CLL Study Group at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna-Maria Fink, MD (+4922147888220, cllstudie@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: from date of registry entry until date of death, up to 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863692, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.