Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID03980002

A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With Chronic Lymphocytic Leukemia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2019-06-10

50

Participants Needed

1

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the response rate and safety of alternating treatment with FCR/BR and ibrutinib in patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy. This prospective multicenter phase 2 study focuses on treatment-naive CLL patients to understand how this combination may affect disease control and patient outcomes. Treatment involves an induction phase where patients under 65 without significant health issues receive 1 or 2 courses of FCR chemotherapy, alternating with 3 months of oral ibrutinib, repeated in cycles. Patients 65 or older, or those under 65 with other health conditions, receive BR chemotherapy similarly alternating with ibrutinib. After induction, maintenance therapy with either ibrutinib or thalidomide is recommended but not mandatory for patients depending on their minimal residual disease status. Participants will be assessed for complete response rate three months after induction, along with other outcomes such as overall response rate, survival over five years, progression-free survival, minimal residual disease negativity, duration of response, and treatment-related side effects. Monitoring includes clinical evaluations and safety assessments throughout treatment and follow-up, lasting until the study's planned completion in 2027.

CONDITIONS

Brief Title

A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 to 75 years
  • Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma meeting IWCLL criteria
  • Treatment-naive patients or those with only short-term substandard prior treatments meeting specific conditions
  • Evidence of CLL/SLL requiring treatment based on blood counts, organ enlargement, lymphocyte changes, or symptoms
  • ECOG performance status between 0 and 2
  • Expected survival of at least 3 months
Not Eligible

You will not qualify if you...

  • History of malignant tumor (except CLL) within the past year, including active CNS lymphoma involvement
  • Transformation to large cell lymphoma or progression to prolymphocytic leukemia
  • Active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura requiring treatment
  • Liver or kidney function outside defined safe limits unrelated to lymphoma
  • Severe or uncontrolled infection
  • Central nervous system dysfunction with symptoms
  • Serious medical conditions affecting study participation
  • Ongoing uncontrolled bleeding or history of major life-threatening bleeding
  • Need for continuous anticoagulation drugs
  • Major surgery within 30 days (excluding lymph node biopsy)
  • Pregnant or breastfeeding women or women of childbearing potential not using contraception
  • Allergy to any study drugs

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 months for induction; maintenance duration varies

Participants receive induction treatment with either FCR or BR chemotherapy courses alternating with oral ibrutinib for a total of 6 months. After induction, maintenance therapy with ibrutinib or thalidomide may be recommended based on patient preference and minimal residual disease status.

Multiple visits over 6 months for alternating treatment cycles and monitoring

Trial Site Locations

Total: 1 location

1

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China, 30020

Actively Recruiting

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Research Team

Z

Zengjun Li

T

Tingyu Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Ibrutinib alternating with three cycles of interval fludarabine, cyclophosphamide, and rituximab (FCR) in adults with untreated chronic lymphocytic leukaemia as time-limited regimen: a single-arm, multicentre phase 2 trial in China.

Tingyu Wang, Yuting Yan, Hui Wang...

https://pubmed.ncbi.nlm.nih.gov/41497516