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Clinical Trials/NCT06250465
NCT06250465RecruitingNot Applicable

AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Arbeitsgemeinschaft medikamentoese Tumortherapie9 sites in 1 country500 target enrollmentStarted: March 24, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
500
Locations
9
Primary Endpoint
General Characteristics

Study Overview

Brief Summary

For until very recently CLL has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. However, the introduction of chemoimmunotherapy in particular the FCR (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of IgVH mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. However, for the largest proportion of all CLL patients the disease is still associated with a reduction in life expectancy as compared to a matched population.

The field has made further substantial progress by the introduction of BTK inhibitors and Bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (MRD), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy.

Due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. Particularly, long-term PFS, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues.

CLL has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of this disease.

Detailed Description

This registry is designed as multicenter observational cohort of patients with CLL. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The registry will include patients ≥ 18 years with CLL.

Exclusion Criteria

  • There are no specific exclusion criteria.

Outcomes

Primary Outcomes

General Characteristics

Time Frame: 7 years

To describe general characteristics of CLL patients

Toxicities

Time Frame: 7 years

To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.

Genetic Profiling

Time Frame: 7 years

To describe genetic risk profiles

Patient Outcome

Time Frame: 7 years

To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.

Proportion of CLL patients in Austria that require treatment

Time Frame: 7 years

To describe the proportion of CLL patients in Austria that require treatment

Number of patients with concomitant diseases

Time Frame: 7 years

To describe concomitant diseases at diagnosis of CLL

Number and type of treatment

Time Frame: 7 years

To describe type and duration of treatment of CLL. Number of patients per treatment, number of treatments per patient.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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