Determinants of the Response to BTK Degraders (BTKd) in Double Refractory Chronic Lymphocytic Leukemia (CLL)

Study investigates why some CLL patients don't respond to new treatments

NCT: NCT07099443 · Status: RECRUITING · Phase: N/A · Sponsor: Nantes University Hospital · Started: 2025-10-09 · Est. Completion: 2039-09-15

Plain English Summary

Determinants of the Response to BTK Degraders (BTKd) in Double Refractory CLL is a Not Applicable clinical trial sponsored by Nantes University Hospital studying Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia. This study collects blood or bone marrow samples from patients with a specific type of leukemia called Chronic Lymphocytic Leukemia (CLL). It is for patients with CLL that has stopped responding to two common treatments (BTK inhibitors and BCL-2 inhibitors). Participation involves providing a blood or bone marrow sample, which is already planned as part of your regular medical care or a lymph node biopsy. There is no new treatment given in this study; it focuses on understanding why some patients' leukemia doesn't respond to certain therapies. The trial aims to enroll 60 participants.

Official Summary

The aim of the REBELLE cohort - bio-collection is to collect samples from patients with Chronic Lymphocytic Leukemia (CLL), to facilitate access for the National Institute of Health and Medical Research (INSERM) to patients with double-refractory CLL. To do this, an additional blood or bone marrow sample to those planned in the context of patient care or a residual lymph node biopsy sample will be collected after signing consent. These samples will first be sent to the Filothèque for temporary storage, and will then be transferred to CRCI²NA (Nantes - Angers Cancer and Immunology Research Center) for analysis with the aim of studying the mechanisms of resistance and response to BTK degraders (BTKd).

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with Chronic Lymphocytic Leukemia (CLL) that has become resistant to both BTK inhibitors and BCL-2 inhibitors. Patients who have progressed on or after these treatments, or have known genetic resistance. Patients must be adults and covered by social security. Patients who are minors, under guardianship, or protected persons cannot participate. This trial is studying Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how researchers will study the biological reasons why the leukemia cells stop responding to BTK degraders, helping to identify potential new ways to overcome this resistan The specific primary outcome measures are: Characterization of resistance mechanisms to BTK degraders in double-refractory CLL patients (Up to 5 years after inclusion). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to understand why some patients with difficult-to-treat CLL do not respond to newer therapies, which could lead to better treatment strategies in the future. This research targets Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, where improved treatment options are needed.

Investor Insight

This observational study aims to gather crucial biological data on a resistant form of CLL, which could inform the development of future targeted therapies and potentially expand the market for novel

Is This Trial Right for Me?

Ask your doctor if your CLL is considered 'double refractory' and if providing an extra sample would be appropriate for you. Understand that the sample collection is part of your existing medical care or a planned biopsy, and no new treatment is given. The samples will be analyzed to understand resistance mechanisms, which may help future patients. This trial is currently recruiting participants. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Patient with confirmed double refractory CLL to both BTKi and BCL-2i, defined as:

  * Any patient who has received both a BTKi and a BCL-2i, regardless of treatment regimen, and has shown clinical progression either during treatment with both BTKi and BCL-2i, or within 36 months after stopping BCL-2i.
  * Any patient identified with known biological resistance mutations to BTKi or BCL-2i, regardless of clinical progression.
* Patient who has provided informed consent to participate in the study.
* Patient covered by a social security health insurance plan

Exclusion Criteria:

* Minor patients.
* Adults under guardianship.
* Protected persons.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07099443?

NCT07099443 is a Not Applicable OBSERVATIONAL study titled "Determinants of the Response to BTK Degraders (BTKd) in Double Refractory CLL." It is currently recruiting and is sponsored by Nantes University Hospital. The trial targets enrollment of 60 participants.

What conditions does NCT07099443 study?

This trial investigates treatments for Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia. The primary condition under study is Chronic Lymphocytic Leukemia.

What treatments are being tested in NCT07099443?

The interventions being studied include: Non-Interventional Sample Collection and Analysis (OTHER). This study is observational. Biological samples are collected as part of standard care or for research purposes and analyzed to characterize resistance mechanisms. No treatment or intervention is administered as part of the study protocol.

What does Not Applicable mean for NCT07099443?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07099443?

This trial is currently "Recruiting." It started on 2025-10-09. The estimated completion date is 2039-09-15.

Who is sponsoring NCT07099443?

NCT07099443 is sponsored by Nantes University Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07099443?

The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.

How is NCT07099443 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07099443?

The primary outcome measures are: Characterization of resistance mechanisms to BTK degraders in double-refractory CLL patients (Up to 5 years after inclusion). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07099443 being conducted?

This trial is being conducted at 14 sites, including Angers; Bordeaux; Clermont-Ferrand; La Roche-sur-Yon and 10 more sites (France).

Where can I find official information about NCT07099443?

The official record for NCT07099443 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07099443. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07099443 testing in simple terms?

This study collects blood or bone marrow samples from patients with a specific type of leukemia called Chronic Lymphocytic Leukemia (CLL). It is for patients with CLL that has stopped responding to two common treatments (BTK inhibitors and BCL-2 inhibitors).

Why is this trial significant?

This trial is important because it aims to understand why some patients with difficult-to-treat CLL do not respond to newer therapies, which could lead to better treatment strategies in the future.

What are the potential risks of participating in NCT07099443?

The main risk is related to the sample collection itself (e.g., bruising from a blood draw or discomfort from a biopsy), which is similar to standard medical procedures. There are no treatment-related risks as no new treatment is administered in this study. The samples will be stored and analyzed, and while efforts are made to protect privacy, there's a theoretical risk of incidental findings in the genetic analysis. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07099443?

Ask your doctor if your CLL is considered 'double refractory' and if providing an extra sample would be appropriate for you. Understand that the sample collection is part of your existing medical care or a planned biopsy, and no new treatment is given. The samples will be analyzed to understand resistance mechanisms, which may help future patients. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07099443 signal from an investment perspective?

This observational study aims to gather crucial biological data on a resistant form of CLL, which could inform the development of future targeted therapies and potentially expand the market for novel This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing a blood or bone marrow sample, which is already planned as part of your regular medical care or a lymph node biopsy. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.