Evaluating a new treatment approach for chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter phase 2 study aims to assess the safety and response rate of alternating treatments of FCR/BR with ibrutinib in patients who have not previously received treatment for chronic lymphocytic leukemia (CLL). The study focuses on treatment-naive patients diagnosed with CLL/SLL, utilizing a combination of established therapies and a novel agent. By alternating these treatment regimens, the study seeks to improve patient outcomes and provide insights into effective management strategies for CLL.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or women ≥ 18 years and ≤ 75 of age.
2. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria.
3. Treatment-naive patients. Those patients received short-term substandard treatment are permitted if meet all the items listed below:

   1. Untreated with combined chemotherapy such as CHOP ,COP and so on.
   2. Unteated with chemotherapy regimens including fludarabine and bendamustine.
   3. Unteated with Ibrutinib.
   4. If treated with chlorambucil or cyclophosphamide,should less than 3 weeks.
   5. If treated with interferon, should less than 6 months.
   6. No objective response are achieved (PR or CR).
4. CLL/SLL requiring treatment as defined by at least one of the following criteria:

   1. Development of, or worsening of, anemia to Hb\<100g/L (non-hemolytic) .
   2. Development of, or worsening of, thrombocytopenia to PLT\<100,000/L.
   3. Massive (≥ 6 cm below left costal margin), progressive or symptomatic splenomegaly.
   4. Massive nodes (≥ 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy .
   5. Progressive lymphocytosis with an increase of \> 50% over a 2-month period or lymphocyte-doubling time of \< 6 months. Lymphocyte-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of \< 30,000/L, LDT should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (eg, infection, use glucocorticoid) should be excluded. f)Symptomatic or functional extranodal sites involved s (eg. Skin,kidney, lungs and so on).

   g)Constitutional symptoms, defined as any 1 or more of the following disease-related symptoms or signs: i. Unintentional weight loss of ≥ 10% within the previous 6 months ii.Significant fatigue (ie, inability to work or perform usual activities)
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6. Expected to survival period for 3 months or more.

Exclusion Criteria:

1. History of malignant tumour except CLL in the past 1year(including active central nervous system (CNS) involvement with lymphoma).
2. Transformed to large cell lymphoma manifested by clinical evidence, or progressed to prolymphocytic leukemia(PLL).
3. Have active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, and require treatment.
4. Inadequate hepatic and renal function defined as: AST and ALT \>4.0 x upper limit of normal (ULN), bilirubin \>2.0 x upper limit of normal (ULN), Adequate renal function defined by serum creatinine \>1.5 x upper limit of normal (ULN),unrelated to lymphoma.
5. Severe or uncontrolled infection.
6. Central nervous system (CNS) dysfunction with clinical manifestation.
7. Other serious medical diseases that may affect the study（eg. Uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary disease),and final decided by the investigator.
8. Ongoing and uncontrolled bleeding
9. History of major life-threatening bleeding, especially due to irreversible cause.
10. Requirement for continuous anticoagulation drugs.
11. Major surgery within 30 days(excluding lymph node biopsy).
12. Pregnant or Lactating women, or women of reproductive age refusal to take contraceptive measures.
13. Allergy to any drug used in the study.

Where it's running

• Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Zengjun Li — Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Zengjun Li
• Email: lizengjun@ihcams.ac.cn
• Phone: +86 13642138692

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Nemtabrutinib to Ibrutinib or Acalabrutinib for First Line Treatment of Chronic Lymphocytic Leukemia

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• Using ibrutinib to treat autoimmune hemolytic anemia in patients with chronic lymphocytic leukemia

  This study is testing if the drug ibrutinib can help adults with chronic lymphocytic leukemia who also have autoimmune hemolytic anemia feel better.

  Recruiting at 3 sites Phase 2 Gruppo Italiano Malattie EMatologiche dell'Adulto · Florence and 2 other locations · NCT05694312

• Pirtobrutinib versus ibrutinib for people with CLL or SLL.

  This trial will test whether pirtobrutinib works better or is safer than ibrutinib for adults with CLL/SLL, with a separate part that tries pirtobrutinib alone in treatment‑naïve patients who have a 17p deletion.

  Recruiting at 93 sites Phase 3 Eli Lilly and Company · Anaheim, California and 142 other locations · NCT05254743

• Fixed-duration treatment for chronic lymphocytic leukemia with ibrutinib and obinutuzumab

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• Intermittent dosing of ibrutinib for advanced chronic lymphocytic leukemia

  This study is testing if taking the cancer drug ibrutinib in a 'ON-OFF' way can help people with advanced chronic lymphocytic leukemia stay healthy while possibly having fewer side effects and lower costs.

  Recruiting at 6 sites Phase 1/2 Karolinska University Hospital · Trondheim and 8 other locations · NCT04771507

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.