NCT02863692

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2013Dec 2026

Study Start

First participant enrolled

August 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

13.3 years

First QC Date

February 26, 2015

Last Update Submit

December 1, 2025

Conditions

CLLSLLHCLRichter´s TransformationLeukemia, Prolymphocytic, B-CellLeukemia, Prolymphocytic, T-CellT-LGL LeukemiaNK-LGL Leukemia

Keywords

CLLB-PLLT-PLLSLLT-NK-LGLHCLRichter´s Transformation

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall survival will be measured from date of registry entry until date of death

    from date of registry entry until date of death, up to 12 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK-LGL, HCL or Richter's transformation
  • 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)

You may not qualify if:

  • Patients without confirmed diagnosis of CLL, B-PLL, T-PLL, SLL, T or NK- LGL, HCL or Richter's transformation
  • Cerebral dysfunction, legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAG Freiberg-Richter, Jacobasch, Wolf, Illmer

Dresden, Saxony, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 38693677BACKGROUND

  • Furstenau 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.

    PMID: 34591989BACKGROUND

  • von 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.

    PMID: 37358640DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Prolymphocytic, B-CellLeukemia, Prolymphocytic, T-CellLeukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsLeukemia, ProlymphocyticHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, T-Cell

Study Officials

  • Michael Hallek, MD

    German CLL Study Group, Department I of Internal Medicine University Hospital Cologne

    STUDY DIRECTOR

Central Study Contacts

Anna-Maria Fink, MD

CONTACT

+4922147888220cllstudie@uk-koeln.de

Central Study Office of the German CLL Study Group

CONTACT

+4922147888220cllstudie@uk-koeln.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
25 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

August 11, 2016

Study Start

August 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations

DE(1)