Clinical trial · Interventional
Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell Transplant
Phase I Study of Adoptive Immunotherapy With CD8 Minor Histocompatibility (H) Antigen-Specific CTL Clones for Patients With Relapsed of AML or ALL After Allogeneic Hematopoietic Stem Cell Transplant
- 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)
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after donor stem cell transplant.
Conditions
Conditions (2)
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity
Secondary outcomes (3)
- measure
- In vivo persistence of adoptively transferred T cells
- measure
- Migration of adoptively transferred T cells to the bone marrow
- measure
- Antileukemic activity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Undergoing allogeneic hematopoietic stem cell transplantation\* from a major histocompatability complex (MHC)-identical related donor for 1 of the following:
* Primary refractory acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
* AML or ALL beyond first remission
* Therapy-related AML at any stage
* Philadelphia chromosome (bcr-abl)-positive p190-positive ALL at any stage
* Acute leukemia at any stage arising from myelodysplastic syndromes or myeloproliferative disorders, including any of the following:
* Chronic myelomonocytic leukemia
* Chronic myelogenous leukemia
* Polycythemia vera
* Essential thrombocytosis
* Agnogenic myeloid metaplasia with myelofibrosis
* Refractory anemia with excess blasts
* Refractory anemia with excess blasts in transformation NOTE: \*Patients must be enrolled on study prior to undergoing transplantation
* Relapsed disease post-transplantation, as evidenced by 1 of the following criteria:
* Morphologic relapse, as defined by 1 or more of the following:
* Peripheral blasts in the absence of growth factor therapy
* Bone marrow blasts \> 5% of nucleated cells
* Extramedullary chloroma or granulocytic sarcoma
* Flow cytometric relapse, as defined by the appearance of cells with abnormal immunophenotype consistent with leukemia relapse in the peripheral blood or bone marrow (detected before transplantation)
* Cytogenetic relapse, as defined by the appearance in 1 or more metaphases from bone marrow or peripheral blood cells of either a non-constitutional cytogenetic abnormality detected in at least 1 cytogenetic study performed before transplantation OR a new abnormality known to be associated with leukemia
* Molecular relapse, as defined by 1 of the following:
* 1 or more positive polymerase chain reaction (PCR) assays for clonotypic immunoglobulin heavy chain or T-cell receptor gene rearrangement in patients transplanted for B- or T-cell ALL respectively
* 1 or more positive post-transplantation reverse transcription PCR assays for p190 BCR-ABL mRNA fusion transcripts in patients transplanted for Philadelphia chromosome-positive p190-positive ALL
* No grade III or IV acute graft-versus-host disease (GVHD)\*\*
* No extensive chronic GVHD\*\* NOTE: \*\*At time of post-transplant relapse
PATIENT CHARACTERISTICS:
Age
* 14 and over (patients \< 14 years of age may be eligible if they are deemed to be of sufficient height and weight by the pediatric attending physician)
Performance status
* Karnofsky 60-100% (at time of post-transplant relapse)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No preexisting major nonhematopoietic organ toxicity ≥ grade 3 (at time of post-transplant relapse)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Concurrent immunosuppressive steroid therapy for GVHD allowed provided both of the following are true:
* Able to taper steroid dose to \< 0.5 mg/kg/day
* No increase of \> 1 grade in acute GVHD OR progression of chronic GVHD within 14 days after dose change
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (2)
- DERIVEDWarren EH, Fujii N, Akatsuka Y, Chaney CN, Mito JK, Loeb KR, Gooley TA, Brown ML, Koo KK, Rosinski KV, Ogawa S, Matsubara A, Appelbaum FR, Riddell SR. Therapy of relapsed leukemia after allogeneic hematopoietic cell transplantation with T cells specific for minor histocompatibility antigens. Blood. 2010 May 13;115(19):3869-78. doi: 10.1182/blood-2009-10-248997. Epub 2010 Jan 13. PMID 20071660
- DERIVEDRosinski KV, Fujii N, Mito JK, Koo KK, Xuereb SM, Sala-Torra O, Gibbs JS, Radich JP, Akatsuka Y, Van den Eynde BJ, Riddell SR, Warren EH. DDX3Y encodes a class I MHC-restricted H-Y antigen that is expressed in leukemic stem cells. Blood. 2008 May 1;111(9):4817-26. doi: 10.1182/blood-2007-06-096313. Epub 2008 Feb 25. PMID 18299450