Clinical trial · Interventional
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising. In this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Application of activated donor T cells | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility of the infusion of in-vitro activated donor T cells
- timeFrame
- 5 years
- measure
- kinetic of BCR-ABL load after transplantation
- timeFrame
- 5 years
Secondary outcomes (2)
- measure
- Rate of acute and chronic GvHD
- timeFrame
- 3 years
- measure
- Rate of infectious complications
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * age 18-60 * Ph+ CML * HLA A0201, 0301, 1101, B0801 * BCR-ABL b3a2 positive * no significant comorbidities * resistance or intolerance of imatinib Exclusion Criteria: * HIV positive * blast crisis
References
Publications (2)
- RESULTBornhauser M, Thiede C, Babatz J, Schetelig J, Illmer T, Kiani A, Platzbecker U, Herr W, Rieber EP, Ehninger G, Schmitz M. Infusion of bcr/abl peptide-reactive donor T cells to achieve molecular remission of chronic myeloid leukemia after CD34+ selected allogeneic hematopoietic cell transplantation. Leukemia. 2006 Nov;20(11):2055-7. doi: 10.1038/sj.leu.2404383. Epub 2006 Aug 31. No abstract available. PMID 16990776
- DERIVEDBornhauser M, Thiede C, Platzbecker U, Kiani A, Oelschlaegel U, Babatz J, Lehmann D, Holig K, Radke J, Tuve S, Wermke M, Wehner R, Jahnisch H, Bachmann MP, Rieber EP, Schetelig J, Ehninger G, Schmitz M. Prophylactic transfer of BCR-ABL-, PR1-, and WT1-reactive donor T cells after T cell-depleted allogeneic hematopoietic cell transplantation in patients with chronic myeloid leukemia. Blood. 2011 Jun 30;117(26):7174-84. doi: 10.1182/blood-2010-09-308569. Epub 2011 May 3. PMID 21540460