Clinical trial · Interventional
Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant
Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplantation From a Haploidentical Donor for Patients With Acute Leukemia and Myelodysplasia
- 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: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methylprednisolone and antithymocyte globulin before transplant and peripheral blood cells that have been treated in the laboratory after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated peripheral blood cell infusion after donor stem cell transplant in treating patients with hematologic cancers or other diseases.
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 |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| methylprednisolone | Drug | — | UNRESOLVED |
| peripheral blood lymphocyte therapy | Biological | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
| total-body irradiation | Radiation | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- administration of adoptive donor lymphocyte infusion
- description
- administration of donor lymphocytes made using costimulatory blockade ex vivo
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: peripheral blood lymphocyte therapy
- Drug: fludarabine phosphate
- Drug: methylprednisolone
- Drug: thiotepa
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: in vitro-treated peripheral blood stem cell transplantation
- Radiation: total-body irradiation
Primary outcomes (3)
- measure
- Feasibility of making and administering the adoptive T cell product
- timeFrame
- from conditioning through administration of anergized cells on day 35-42
- description
- ability to collect sufficient cells, make anergized product with good viability, without contamination and infuse per study toxicity of the conditioning regimen, the likelihood of engraftment, and the subsequent percentage of individuals who would be eligible to receive aDLI were determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Acute lymphocytic leukemia
* In ≥ second complete remission (CR), defined as \< 5% blasts in bone marrow (BM) and no active extramedullary disease OR in first CR with any of the following high risk features:
* History of induction failure
* Philadelphia chromosome positive
* t(4;11) by cytogenetic analysis
* Any infant with MLL rearrangements on cytogenetic analysis
* No relapse with isolated extramedullary disease after completion of prior treatment
* Acute myeloid leukemia
* Failed induction therapy after \< 3 courses
* In ≥ second CR, defined as \< 5% blasts in BM and no active extramedullary disease OR in first CR with any of the following high-risk features:
* History of induction failure = 5q- or monosomy 7 cytogenetic findings
* Any of the following myelodysplastic syndromes:
* Refractory anemia (RA) with excess blasts (RAEB) with a high International Prognostic Scoring System (IPSS) score or score of intermediate-1(INT-1) or intermediate-2 (INT-2)
* RAEB in transformation with INT-1, INT-2, or high IPSS score
* RA with INT-2 score
* Patients must have a healthy, related donor who is at least genotypically HLA-A, B, C, and DR haploidentical to the patient
* No suitably matched family donor defined by genotypic or phenotypic identity for ≥ 5/6 A, B, or DR loci
* No immediately available genotypically matched (6/6) unrelated marrow donor
* No immediately available umbilical cord blood donor with suitable cell dose after a search ≥ 2 months
* Patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search are eligible
* Has a parent with a haplotype that is disparate from that of the donor for the haplotype shared by the patient and parent, but not shared by the patient and donor OR patient is able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
* No active CNS disease
PATIENT CHARACTERISTICS:
* Room air O\_2 saturation \> 95% unless the lungs are involved with disease
* No clinical evidence of pulmonary insufficiency unless the lungs are involved with disease
* AST and ALT \< 3 times upper limit of normal (ULN)\*
* Bilirubin \< 2.0 mg/dL\*
* Creatinine \< 2 times ULN OR creatinine clearance or glomerular filtration rate \> 50% of the lower limit of normal
* LVEF \> 45% OR shortening fraction \> 20%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection, defined as absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms
* No evidence of HIV infection OR known HIV positivity NOTE: \*Does not apply if liver is involved with disease
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior stem cell transplantation
* No other concurrent immunosuppressive therapyReferences
Publications (1)
- RESULTDavies JK, Brennan LL, Wingard JR, Cogle CR, Kapoor N, Shah AJ, Dey BR, Spitzer TR, de Lima M, Cooper LJ, Thall PF, Champlin RE, Nadler LM, Guinan EC. Infusion of Alloanergized Donor Lymphocytes after CD34-selected Haploidentical Myeloablative Hematopoietic Stem Cell Transplantation. Clin Cancer Res. 2018 Sep 1;24(17):4098-4109. doi: 10.1158/1078-0432.CCR-18-0449. Epub 2018 May 16. PMID 29769208