Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02863692
Other study ID # CLL-Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2013
Est. completion date December 2026

Study information

Verified date March 2024
Source German CLL Study Group
Contact Anna-Maria Fink, MD
Phone +4922147888220
Email cllstudie@uk-koeln.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany BAG Freiberg-Richter, Jacobasch, Wolf, Illmer Dresden Sachsen

Sponsors (1)

Lead Sponsor Collaborator
German CLL Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 pa — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02229422 - A Study of Obinutuzumab(GA101) in Combination With High-Dose Methylprednisolone(HDMP) in Chronic Lymphocytic Leukemia(CLL) Patients (GA101 & HDMP) Phase 1/Phase 2
Active, not recruiting NCT03997968 - A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT01862445 - Retrospective Study: Efficacy and Safety of Chlorambucil + Rituximab in CLL Patients
Completed NCT00535873 - Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older Phase 2
Withdrawn NCT03639324 - Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL Phase 1
Recruiting NCT05517265 - Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)
Recruiting NCT03868722 - Acalabrutinib and Venetoclax Treatment of Newly Diagnosed Patients With CLL at High Risk of Infection or Early Treatment Phase 2/Phase 3
Recruiting NCT04640909 - Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients N/A
Recruiting NCT05610228 - Study of the Metabolism in the Lymphatic Niche of CLL
Completed NCT01168921 - Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL) Phase 2
Withdrawn NCT05209308 - Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL Phase 2
Completed NCT00792077 - A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue Phase 2
Recruiting NCT06073821 - Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) Phase 3
Recruiting NCT05246345 - Venetoclax Resistance Landscape in Chronic Lymphocytic Leukemia
Terminated NCT01532635 - A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives Phase 2
Completed NCT01703364 - Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated CLL Phase 1/Phase 2
Terminated NCT03572634 - Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL Phase 1/Phase 2
Completed NCT03231579 - Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study
Completed NCT00636909 - Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders Phase 2
Active, not recruiting NCT03524235 - Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL Phase 1