Trials / Withdrawn
WithdrawnNCT03982992
Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab
Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab in Patients With Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia After Allogeneic Stem Cell Transplantation
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ludwig-Maximilians - University of Munich · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase 2 study is designed to evaluate the safety, tolerability and efficacy of allogeneic donor lymphocyte infusions (DLI) combined with the bispecific T cell engager blinatumomab in B-precursor ALL patients who have mixed chimerism (MC) or are MRD-positive after allogeneic SCT and are refractory to at least one MRD- or MC-targeted therapy (i.e. blinatumomab, DLI, tyrosine kinase inhibitors or other agents).
Conditions
- B Cell Precursor Acute Lymphoblastic Leukemia With Mixed Chimerism or Minimal Residual Disease After Allogeneic Stem Cell Transplantation
- B-Cell Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia
- Acute Lymphoblastic Leukemia in Remission
- Acute Lymphoblastic Leukemia, Adult
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Blinatumomab in combination with donor lymphocyte infusion | Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2021-05-31
- Completion
- 2021-11-30
- First posted
- 2019-06-12
- Last updated
- 2024-03-12
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03982992. Inclusion in this directory is not an endorsement.