Clinical trial · Interventional
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
Objectives: 1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants. 2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion. 3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Stem Cell Transplant | Biological | Hematopoietic Cell Transplantation | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apheresis + Transplant
- description
- Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
- interventionNames
- Procedure: Apheresis
- Biological: Stem Cell Transplant
Primary outcomes (1)
- measure
- Participant Toxicity Levels
- timeFrame
- From stem cell transplant baseline to 30 plus days post transplant.
- description
- Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant. * Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration. * Stem cell or marrow donor willing to have apheresis for T-Cell collection. * Written voluntary informed consent must be obtained from patient and donor. Exclusion Criteria: * Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure. * AML French-American-British (FAB) subtype M3.
References
Publications (0)
Data not yet available