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Chronic Lymphocytic LeukemiaPhase 2BDHCLL001NCT03980002

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

A Phase 2 study testing FCR and Ibrutinib, BR and Ibrutinib and Ibrutinib and Thalidomide in people with Chronic Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
FCR and Ibrutinib, BR and Ibrutinib and Ibrutinib and Thalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
15 May 2019to 30 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women ≥ 18 years and ≤ 75 of age.
  • Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria.
  • Treatment-naive patients. Those patients received short-term substandard treatment are permitted if meet all the items listed below:
  • Untreated with combined chemotherapy such as CHOP ,COP and so on.
  • Unteated with chemotherapy regimens including fludarabine and bendamustine.
  • Unteated with Ibrutinib.
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  • If treated with chlorambucil or cyclophosphamide,should less than 3 weeks.
  • If treated with interferon, should less than 6 months.
  • No objective response are achieved (PR or CR).
  • CLL/SLL requiring treatment as defined by at least one of the following criteria:
  • Development of, or worsening of, anemia to Hb<100g/L (non-hemolytic) .
  • Development of, or worsening of, thrombocytopenia to PLT<100,000/L.
  • Massive (≥ 6 cm below left costal margin), progressive or symptomatic splenomegaly.
  • Massive nodes (≥ 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy .
  • 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)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Expected to survival period for 3 months or more.

Who cannot join

  • History of malignant tumour except CLL in the past 1year(including active central nervous system (CNS) involvement with lymphoma).
  • Transformed to large cell lymphoma manifested by clinical evidence, or progressed to prolymphocytic leukemia(PLL).
  • Have active autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, and require treatment.
  • 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.
  • Severe or uncontrolled infection.
  • Central nervous system (CNS) dysfunction with clinical manifestation.
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  • Other serious medical diseases that may affect the study（eg. Uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary disease),and final decided by the investigator.
  • Ongoing and uncontrolled bleeding
  • History of major life-threatening bleeding, especially due to irreversible cause.
  • Requirement for continuous anticoagulation drugs.
  • Major surgery within 30 days(excluding lymph node biopsy).
  • Pregnant or Lactating women, or women of reproductive age refusal to take contraceptive measures.
  • Allergy to any drug used in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zengjun Li contact

+86 13642138692

lizengjun@ihcams.ac.cn

Tingyu Wang contact

+86 15692201678

wangtingyu@ihcams.ac.cn

China1 site, 1 recruiting

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

    Tianjin, Tianjin Municipality, 30020

    Zengjun Li, +86 13642138692, lizengjun@ihcams.ac.cn

    Tingyu Wang, +86 15692201678, wangtingyu@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

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

This is a prospective multicenter phase 2 study designed with the purpose to evaluate the response rate and safety of treatment with FCR/BR alternating with ibrutinib in treatment-naive patients with chronic lymphocytic leukemia.

Being tested
FCR and Ibrutinib, BR and Ibrutinib, Ibrutinib and Thalidomide
Keywords
Chronic Lymphocytic Leukemia, Therapeutics, ibrutinib, fludarabine, rituximab, bendamustine, cyclophosphamide, treatment-naive
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FCR and IbrutinibDrug

    Induction treatment:

    Patients <65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count <10×10^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles.

    1. FCR： F（Fludarabine）：25mg/m2·d，d1-3； C（Cyclophosphamide）：CTX 250mg /m2·d，d1-3； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）；
    2. Ibrutinib:420mg/d

  • BR and IbrutinibDrug

    Induction treatment:

    Patients ≥65y and ≤75 y or <65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR： B（Bendamustine）：90mg/m2·d，d1-2； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）； 2. Ibrutinib: 420mg/d

  • Ibrutinib and ThalidomideDrug

    Maintenance treatment:

    After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy.

Study groups in NCT03980002
Study groupRoleWhat they receive
FCR/BR alternating with ibrutinibExperimentalFCR/BR→ ibrutinib✖️3months→FCR/BR→ ibrutinib✖️3months→FCR/BR→Maintenance therapy
Receives: Drug: FCR and Ibrutinib; Drug: BR and Ibrutinib; Drug: Ibrutinib and Thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRR

    Rate of complete remission

    Measured: 3 months after completion of induction therapy

Secondary outcomes (6)

  1. ORR

    Overall Response Rate

    Measured: 3 months after completion of induction therapy

  2. OS

    Overall survival

    Measured: 5 years

  3. PFS

    Progression-free survival

    Measured: 5 years

  4. MRD negative rate

    the rate of undetectable tumor cells in bone marrow and/or peripheral blood by multicolor flow cytometry

    Measured: 3 months after completion of induction therapy

  5. DoR

    Duration of Response

    Measured: 5 years

  6. Treatment-related side effects

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2019
  2. Study start15 May 2019
  3. Primary completion15 Dec 2022 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03980002
Sponsor's protocol ID
IHBDH-IIT2018009
Acronym
BDHCLL001
Status last verified
Jun 2019
First submitted
6 Jun 2019
Last updated
10 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang T, Yan Y, Wang H, Sun Y, Liu X, Lyu R, Xiong W, An G, Liu W, Xu Y, Deng S, Wang Q, Du C, Huang L, Zou D, Zhao Y, Qiu L, Li Z, Yi S. 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. EClinicalMedicine. 2025 Dec 5;90:103688. doi: 10.1016/j.eclinm.2025.103688. eCollection 2025 Dec.

    PubMed 41497516

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FCR and Ibrutinib, BR and Ibrutinib and Ibrutinib and Thalidomide in people with Chronic Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zengjun Li (+86 13642138692, lizengjun@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRR (time frame: 3 months after completion of induction therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03980002, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.

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