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Trial record 4 of 15 for:    Blastic Plasmacytoid Dendritic Cell Neoplasm

Combination Chemotherapy in Patients With Newly Diagnosed BPDCN (LpDessai)

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ClinicalTrials.gov Identifier: NCT03599960
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
UMR1098, EFS BFC, BESANCON
Centre Henri Becquerel
Maisonneuve-Rosemont Hospital
Centre Hospitalier Universitaire Dijon
Inserm CIC1431, CHU Besancon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
Patients with suspected BPDCN and meeting eligibility criteria will be enrolled in the study. First, BPDCN diagnosis will be confirmed by anatomic pathology (Dr Petrella T, Montreal) and cytologic plus immunophenotyping analysis (Pr Garnache Ottou F, UMR1098 BESANCON). Patients will then receive three 21 days cycles of a combination of chemotherapy (Ida/Metho/L-asp/Dex), followed by an evaluation. Patients with complete response (CR) or complete response with incomplete bone marrow recovery (CRi) will undergo an allo- or auto-SCT and those who are not eligible to the transplantation will have successive 28 days cycles of chemotherapy (Metho/L-asp/Dex). Patients who did not respond to the treatment will be treated by physicians. All patients will be followed for 24 months.

Condition or disease Intervention/treatment Phase
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Drug: Chemotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients will receive 3 cycles of a combination of chemotherapy (Met/Ida/L-Asp/Dex)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : May 2022


Arm Intervention/treatment
Experimental: Chemotherapy Drug: Chemotherapy
  • Idarubicin 12mg/m2 IV at D1
  • Methotrexate : 3000 mg/m2 IV at D1 (24H infusion, dosing modification (1500 mg/m²) if CrCl between 50 to 80ml/min or Age ≥70y, alkaline hydration, leucovorin rescue)
  • L-asparaginase (KIDROLASE) : 6000 units/m2 IV at D2, 4, 6, 8 (switch to Erwinia asparaginase 25 000 U/m² with the same drug regimen in case of hypersensitivity reactions or significant diminution of asparaginase activity)
  • Dexamethasone 40mg PO or IV at D1-4 (dose diminution at 20 mg for Age ≥70y)




Primary Outcome Measures :
  1. Proportion of patients with complete response after 3 cycles of chemotherapy [ Time Frame: 12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days)) ]
    Proportion of patients with complete response after 3 cycles of chemotherapy


Secondary Outcome Measures :
  1. Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy [ Time Frame: 12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days)) ]
    Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy

  2. Overall survival [ Time Frame: 24 months ]
    Overall survival

  3. Relapse-free survival [ Time Frame: 24 months ]
    Relapse-free survival

  4. Residual L-asparaginase activity [ Time Frame: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days)) ]
    Residual L-asparaginase activity

  5. Anti-L-asparaginase antibodies levels [ Time Frame: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days)) ]
    Evaluation of the titer of the anti-asparaginase antibody


Other Outcome Measures:
  1. Minimal residual disease analysis [ Time Frame: 24 months ]
    presence of PDC cell blast (CD56 +, NG2 +, BDCA2low, BDCA4low, CD123low, cTCL1high as measured by flow cytometry)



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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:

  • Newly diagnosed BPDCN established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric and/or by the anatomic pathology study of a skin biopsy using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014) or patients with confirmed isolated skin lesion.
  • 18 years of age or older
  • No prior cytotoxic therapy except <2 week of corticosteroids or hydroxyurea
  • ECOG <2
  • Written informed consent
  • Affiliation to the French social security scheme

Exclusion Criteria:

  • Cardiac contra-indication to anthracyclines: cardiac dysfunction events (NYHA grade 3 or 4 and/or LVEF<50%)
  • Hepatocellular abnormalities except if considered related to the BPDCN:

    1. ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN
    2. Total bilirubin ≥ 2.5 x ULN
  • Creatinine level >1.5x ULN or creatinine clearance <50 mL/mn
  • Prior thrombotic event
  • Active hepatitis B or C virus infection
  • HIV positive
  • Serious medical or psychiatric illness that could interfere with the completion of treatment
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Pregnant and lactating female patients
  • Patients diagnosed with or treated for another malignancy within 2 years before study enrollment or with residual disease (basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection)

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): NCT03599960


Contacts
Contact: Eric DECONINCK, MD, PhD +3381668166 edeconinck@chu-besancon.fr

Locations
France
Chu Amiens Not yet recruiting
Amiens, France, 80054
Contact: GRUSON Bérengère, MD         
Chu Besancon Not yet recruiting
Besancon, France, 25030
Contact: DECONINCK ERIC, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
UMR1098, EFS BFC, BESANCON
Centre Henri Becquerel
Maisonneuve-Rosemont Hospital
Centre Hospitalier Universitaire Dijon
Inserm CIC1431, CHU Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03599960     History of Changes
Other Study ID Numbers: LpDessai
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Neoplasms
Dexamethasone
Methotrexate
Idarubicin
Asparaginase
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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic