Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Phase 2LpDessaiNCT03599960
Combination Chemotherapy in Patients With Newly Diagnosed BPDCN
A Phase 2 study testing Chemotherapy in people with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- What is being tested?
- Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesFrance
- Study dates
- 2 May 2019to Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN
- Total bilirubin ≥ 2.5 x ULN
- Creatinine level >1.5x ULN or creatinine clearance (MDRD)<50 mL/mn
- Prior thrombotic event
Show all 12Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
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.
- Being tested
- Chemotherapy
- Medical subject headings
- Blastic Plasmacytoid Dendritic Cell Neoplasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
- Idarubicin 12mg/m2 IV at D1
- Methotrexate at D1 (24H infusion, alkaline hydration, leucovorin rescue):
- Patients <65y and albuminemia >35 g/l and CrCl (MDRD)>60 ml/min: 3000 mg/m²
- Patients <65y and albuminemia <35 g/l and/or CrCl (MDRD) <60 ml/min: 1000 mg/m² IV
- Patients ≥65y and albuminemia >35 g/l and CrCl (MDRD) > 60 ml/min : 1000 mg/m²
- Patients ≥ 65y and albuminemia < 35 g/l and/or CrCl (MDRD) < 60 ml/min : 500 mg/m²
- L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11 (switch to Erwinia asparaginase/Cirsantaspase 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 ≥65y)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Not described Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete response after 3 cycles of chemotherapy
Proportion of patients with complete response after 3 cycles of chemotherapy
Measured: 12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days))
Secondary outcomes (5)
Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy
Proportion of patients with response (complete or partial) after 3 cycles of chemotherapy
Measured: 12 weeks (3 weeks after 3 cycles of chemotherapy (each cycle is 21 days))
Overall survival
Overall survival
Measured: 24 months
Relapse-free survival
Relapse-free survival
Measured: 24 months
Residual L-asparaginase activity
Residual L-asparaginase activity
Measured: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))
Anti-L-asparaginase antibodies levels
Evaluation of the titer of the anti-asparaginase antibody
Measured: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start2 May 2019
- Primary completion13 Feb 2023
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- All patients will receive 3 cycles of a combination of chemotherapy (Met/Ida/L-Asp/Dex)
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- UMR1098, EFS BFC, BESANCON, Centre Henri Becquerel, Maisonneuve-Rosemont Hospital, Centre Hospitalier Universitaire Dijon, Inserm CIC1431, CHU Besancon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599960
- Sponsor's protocol ID
- LpDessai
- Acronym
- LpDessai
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2018
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- ClinicalTrials.gov ID
- NCT03599960
- Acronym / sponsor ID
- LpDessai / LpDessai
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- UMR1098, EFS BFC, BESANCON, Centre Henri Becquerel, Maisonneuve-Rosemont Hospital, Centre Hospitalier Universitaire Dijon, Inserm CIC1431, CHU Besancon
- Study start
- 2 May 2019 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive 3 cycles of a combination of chemotherapy (Met/Ida/L-Asp/Dex)
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
- Creatinine level >1.5x ULN or creatinine clearance (MDRD)<50 mL/mn
- Prior thrombotic event
- Active hepatitis B or C virus infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy* Idarubicin 12mg/m2 IV at D1 * Methotrexate at D1 (24H infusion, alkaline hydration, leucovorin rescue): * Patients <65y and albuminemia >35 g/l and CrCl (MDRD)>60 ml/min: 3000 mg/m² * Patients <65y and albuminemia <35 g/l and/or CrCl (MDRD) <60 ml/min: 1000 mg/m² IV * Patients ≥65y and albuminemia >35 g/l and CrCl (MDRD) > 60 ml/min : 1000 mg/m² * Patients ≥ 65y and albuminemia < 35 g/l and/or CrCl (MDRD) < 60 ml/min : 500 mg/m² * L-asparaginase (SPECTRILA) : 5000 units/m² IV at D2, 5, 8, 11 (switch to Erwinia asparaginase/Cirsantaspase 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 ≥65y) | Drug | Chemotherapy |
Primary outcome
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
5 secondary outcomes
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))
Overall survival
Time frame: 24 months
Relapse-free survival
Time frame: 24 months
Residual L-asparaginase activity
Time frame: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))
Anti-L-asparaginase antibodies levels
Time frame: 12 weeks (Day 8 of each chemotherapy cycle (each cycle is 21 days))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
RecruitingPhase 1/2
CARCIK CD123/33 for Refractory/Relapsed AML and BPDCN in Children and Adults
AML (Acute Myeloid Leukemia), BPDCN
RecruitingObservational study
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
RecruitingPhase 2
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Blastic Plasmacytoid Dendritic Cell Neoplasm
Active, not recruitingEarly Phase 1
CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial
Leukemia, Myeloid, Acute(AML), Precursor Cell Lymphoblastic Leukemia-Lymphoma
Active, not recruitingPhase 1/2
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
Blastic Plasmacytoid Dendritic Cell Neoplasm, Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy in people with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.