Venetoclax SL-401 and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 40
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- sponsor
- M.D. Anderson Cancer Center
Summary
This phase II trial studies how well
Description
PRIMARY OBJECTIVE:
I. To evaluate progression-free survival (PFS) at 12 months of
SECONDARY OBJECTIVES:
I. To determine the safety of the
II. To determine the efficacy by measurement of progression free survival (PFS), overall
response rate (ORR): complete response (CR) and complete response with incomplete marrow
recovery (CRi), clinical complete response (CRc) and
III. To determine the rate of stem cell translant (SCT) within the first 8 cycles
(understanding that some patients won't get SCT) in patients with newly diagnosed
EXPLORATORY OBJECTIVES:
I. To examine expression and function of BCL-2 family proteins and its modulation by VEN in
II. To determine the rate of
III. To determine CD123 levels pre- and post-therapy. IV. To determine molecular mutations
pre-and post-
- OUTLINE
- INDUCTION
CYCLE 1: Patients receive
CYCLES 2, 4, 6, and 8: Patients receive
CYCLES 3 and 7: Patients receive
HYPER-CVAD (AGE < 60): Patients receive
MINI-HYPER-CVD (AGE >= 60): Patients receive
CYCLE 5: Patients receive
MTX/ARAC (AGE < 60): Patients receive
MINI-MTX/ARAC (AGE >= 60): Patients receive
ALL CYCLES: Treatment repeats every 28 days for 8 cycles in the absence of
MAINTENANCE: Patients receive
POMP: Patients receive
After completion of study treatment, patients are followed up at 30 days, and then every 3 months thereafter.
Details
Condition |
|
---|---|
Age | 18years - 100years |
Treatment |
|
Clinical Study Identifier | NCT04216524 |
Sponsor | M.D. Anderson Cancer Center |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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