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Trial record 2 of 5 for:    "Castleman Disease" | "Cyclophosphamide"

BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)

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ClinicalTrials.gov Identifier: NCT03982771
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Li, Peking Union Medical College Hospital

Brief Summary:
To explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (BCD regimen) in newly diagnosed idiopathic Multicentric Castleman's disease (iMCD) patients.

Condition or disease Intervention/treatment Phase
Idiopathic Multicentric Castleman's Disease Drug: Bortezomib Drug: Cyclophosphamide Drug: Dexamethason Phase 2

Detailed Description:
This will be a single center, open-labeled, single arm, phase-II pilot study. The treatment and the response evaluation phase will last from the time of enrollment up to 21 months (evaluation will be carried out every 3 months in the first 9 months and every 6 months from Month 9 to Month 21). The maintenance and follow-up phase to assess for progression of disease will last from 21 months to 45 months after enrollment (evaluation will be carried out every 12 months). The total study duration will be 4 years after the last patient starts study medication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This will be a single center, single arm, phase-II pilot study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Experimental: BCD regimen
Bortezomib, cyclophosphamide and dexamethasone (the BCD regimen) would be utilized in newly diagnosed iMCD (idiopathic Multicentric Castleman's disease) patients
Drug: Bortezomib
-Bortezomib: 1.3mg/m2 subcutaneous injection on Day 1,8,15,22 every month for 9 months; And maintained with 1.3mg/m2 subcutaneous injection every two weeks from Month 9 to 21;

Drug: Cyclophosphamide
-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;

Drug: Dexamethason
Dexamethasone: (oral) 40mg on Day 1,8,15,22 every month for 9 months; and maintained with 20mg (oral) every two weeks from Month 9 to 21.




Primary Outcome Measures :
  1. Overall response [ Time Frame: 12 months after the last patient begins study treatment. ]
    Overall response is composed by biochemical, lymph node and symptom response, is the primary outcome of this study. According to the CDCN response criteria, an overall CR (complete response) requires a complete biochemical, lymph node, and symptomatic response; and overall PR (partial response) requires nothing less than a PR across all categories, but not meeting criteria for CR; an overall SD (stable disease) requires no PD (progression disease) in any of the categories and not meeting the criteria for CR or PR; an overall PD occurs when any category has a PD.


Secondary Outcome Measures :
  1. Time to initial response [ Time Frame: 12 months after the last patient begins study treatment. ]
    defined as the time to achieve the first PR or CR. This outcome can be further divided into time to initial overall response, time to initial symptomatic response, time to initial biochemical response, time to initial lymph node response

  2. Time to best response [ Time Frame: 12 months after the last patient begins study treatment. ]
    defined as the time to achieve the best response (either PR or CR). This outcome can be further divided into time to best overall response, time to best symptomatic response, time to best biochemical response, time to best lymph node response;

  3. Progression-free survival (PFS) [ Time Frame: 12 months after the last patient begins study treatment. ]
    defined as the time to disease PD

  4. Overall survival (OS) [ Time Frame: 12 months after the last patient begins study treatment. ]
    defined as the time to patients' death

  5. Change in PHQ-9 score [ Time Frame: From Day 1 of the BCD treatment until 12 months after the treatment ]
    PHQ-9 score (Patient Health Questionnaire scale-9) is a nine-item self-administered instrument to assess depressive symptoms which incorporates the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) classification for major depressive disorder. Each item is scored 0 - 3, which results in a range of scores between 0 and 27. PHQ-9 scores are interpreted as follows: (1) score <5, no depression; (2) score 5 - 9, mild depression; (3) score 10 - 14, moderate depression; (4) score 15 - 19, moderately severe depression; and (5) score 20 - 27,severe depression.

  6. Change in hemoglobin level [ Time Frame: From baseline until 12 months after the treatment ]
    hemoglobin with g/L as unit of measure

  7. Change in IL-6 (interleukin-6) [ Time Frame: From baseline until 12 months after the treatment ]
    IL-6 level with pg/ml as unit of measure

  8. Change in CRP [ Time Frame: From baseline until 12 months after the treatment ]
    CRP (c-reactive protein) level with mg/L as unit of measure

  9. Change in ESR [ Time Frame: From baseline until 12 months after the treatment ]
    ESR (eerythrocyte sedimentation rate) level with mm/h as unit of measure

  10. Change in IgG level [ Time Frame: From baseline until 12 months after the treatment ]
    IgG (immunoglobin G) level with g/L as unit of measure

  11. Change in MCD-related overall symptom score [ Time Frame: From baseline until 12 months after the treatment ]
    Change of MCD symptom scores. MCD symptom score (MCD disease related overall symptom score) is a 34-item score based on NCI-CTCAE (V4.0) adverse events. Each item is scored 0-5, which results in a range of scores between 0 and 170. More scores indicate more severe disease activity.

  12. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( ≥1 grade) [ Time Frame: 12 months after the last patient begins study treatment. ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)

  13. Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( ≥3 grade) [ Time Frame: 12 months after the last patient begins study treatment ]
    Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Demography: ≥18 years, all race/ethnic groups in China;
  2. Newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic iMCD patients (symptomatic disease is defined by the presence of clinical symptoms with the NCI-CTCAE grading ≥1 that are attributable to the disease, and for which treatment is indicated; iMCD diagnosis is based on the international consensus diagnostic criteria);
  3. Clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1·0 x 109/L, Platelets ≥ 50 x 109/L, Alanine aminotransferase (ALT) within 2·5 x upper limit of normal (ULN); total bilirubin within 2·5 x ULN; estimated glomerular filtration rate (according to MDRD formula) <15ml/min;
  4. Women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. Men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent;
  5. Informed consent must be signed.

Exclusion Criteria:

  1. age under 18 years;
  2. Immunosuppressive or anti-neoplastic drugs within the last 3 months;
  3. serious diseases including malignancy;
  4. Plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women);
  5. Known hypersensitivity to study agents;
  6. Active infection requiring systemic treatment;
  7. Other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study;
  8. Unwilling or unable to provide informed consent;
  9. Unwilling to return for follow-up at PUMCH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982771


Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Jian Li, M.D.    +86-18610852525    lijian@pumch.cn   
Contact: Lu Zhang, M.D.    +86-18610728815    pumczhanglu@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: Jian Li, Professor in hematology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03982771     History of Changes
Other Study ID Numbers: ZS-1892
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jian Li, Peking Union Medical College Hospital:
Idiopathic Multicentric Castleman's Disease
BCD Regimen
Efficacy
Safety

Additional relevant MeSH terms:
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Castleman Disease
Cyclophosphamide
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists