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CLL18

Comparison of three therapies in patients with previously untreated chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL)

Comparison of three therapies in patients with previously untreated chronic
lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL):

  • Time-limited therapy (12 cycles) with venetoclax and obinutuzumab
  • Time-limited therapy (15 cycles) with venetoclax and pirtobrutinib
  • Therapy with venetoclax and pirtobrutinib, of which the duration depends on
    the individual response of the treated person. To determine the response, the number of cancer cells in the blood is measured regularly (individual minimal residual disease, MRD).

The aim is to use the MRD to control the duration of treatment and thereby to improve the treatment results.


Summary of the protocol
CLL is the most common form of leukemia in adults in Switzerland. SLL is a subtype of CLL. Various drugs are available for the treatment of these diseases. Which drug or combination of drugs is used and how long the treatment lasts, depends among other things, on the characteristics of the cancer cells and the stage of the disease. For some patients, treatment is limited in time, for others it is permanent. However, it is not always clear whether temporary treatment or permanent treatment is better.

It may be possible to improve CLL therapy if the number of CLL cells in the blood of a person undergoing treatment is measured regularly; treatment is only stopped when no more CLL cells can be detected in the blood. This form of therapy is known as MRD-guided therapy. MRD measurement involves determining the number of CLL cells in the treated person's blood. MRD measurement is already standard for other cancers, but not yet for the treatment of CLL. This is why MRD-guided therapy is investigated for CLL in this trial. The aim is to improve CLL therapy and adapt it more closely to the needs of patients. The drugs used in the trial are venetoclax, obinutuzumab and pirtobrutinib. Venetoclax and obinutuzumab are approved for CLL therapy. Pirtobrutinib is authorized in the countries of the European Union for the treatment of CLL relapse and; in Switzerland, pirtobrutinib is authorised for the treatment of another cancer, but not for CLL therapy.


Disease being investigated in the trial
Chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL)


Treatment being investigated in the trial
The trial participants are randomly assigned to one of three treatment groups (randomization).

  • Group A: Treatment with venetoclax (tablets) and obinutuzumab (infusions) for approx. 11 months (12 therapy cycles)
  • Group B: Treatment with venetoclax (tablets) and pirtobrutinib (tablets) for approx. 14 months (15 treatment cycles)
  • Group C: Treatment with venetoclax (tablets) and pirtobrutinib (tablets). The duration of treatment depends on the results of the MRD measurement. Treatment is discontinued if no CLL cells are detected in the blood in two consecutive MRD measurements or if the number of CLL cells in the blood no longer decreases. The therapy lasts between 14 and 33 months (15 to 36 therapy cycles).

The results achieved in the three groups are compared with each other.


Inclusion criteria
The people who take part in the trial must fulfil various requirements. The most important include:

  • Age: at least 18 years.

 

Exclusion criteria
Not all people with CLL/SLL can take part in the trial. The most important exclusion
criteria that include

  • The CLL/SLL has already been treated once.
  • The disease is so advanced that the person requires treatment other than trial therapies.
  • The person concerned has other significant illnesses, for example another cancer, a serious infectious disease or an increased risk of bleeding.

Further Studies: Lymphomas

EMCL-Registry

Creation of a European mantle cell lymphoma registry
Recruitment completed

SAKK 38/23 LIBERTY

Non-Hodgkin B-cell lymphoma
Recruitment completed

HOVON 127/ SAKK 37/16

Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DAEPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma
Recruitment completed

IELSG-37

A randomized, open-label, multicentre, two-arm phase III comparative study assessing the role of mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL).

MorningLyte

MORNINGLYTE: international, multicenter phase III study to evaluate the efficacy and tolerability of mosunetuzumab in combination with lenalidomide compared to standard treatment in patients with previously untreated follicular lymphoma.

NX-5948-301

NX-5948-301 A Phase I study to determine the best dose(s) for the treatment of adult patients with B-cell lymphoma or leukemia who have relapsed and/or have not responded to other treatment with the investigational compound NX-5948, which degrades the enzyme Bruton's tyrosine kinase.
Recruitment completed

SAKK 38/19

SAKK 38/19 Therapy adjustment based on PET/CT and circulating tumor DNA in patients with diffuse large B-cell lymphoma
Recruitment completed

IELSG-47

MALIBU trial – Phase II study of combination ibrutinib and rituximab in untreated marginal zone lymphomas

IELSG-48

Phase 3, interventional, multicentre, open-label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ)