Trials / Not Yet Recruiting
Not Yet RecruitingNCT05054478
Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation
Primary Plasma Cell Leukemia: a Prospective Phase 2 Study Incorporating Daratumumab to Chemotherapy and Stem Cell Transplantation : PCL-2 Study
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
Single-Arm phase 2 trial evaluating efficacy of incorporating Daratumumab to treatment of newly diagnosed primary plasma cell leukemia. Treatment will be based on Dara-VRd induction followed by first ASCT, Dara-VRd for first consolidation, second ASCT, Dara-VRd for 1 year as second consolidation and Lenalidomide for 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daratumumab | Daratumumab added to induction, first consolidation and second consolidation |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2024-06-01
- Completion
- 2028-02-01
- First posted
- 2021-09-23
- Last updated
- 2021-09-23
Source: ClinicalTrials.gov record NCT05054478. Inclusion in this directory is not an endorsement.