Adoptive Transfer of Haplo-identical DLI for AML and MDS

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome

In brief

The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease (GVHD) or increased treatment-related mortality. The Investigator further believes that this will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy alone, and that that this benefit will be even greater in donor-recipient pairs that share maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part of this trial will include immune function assays as well as assessments of efficacy, toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with biologic correlates (cytokine and genomic profiles) and clinical outcomes.

Key facts

Study ID: NCT02046122
Run by: Duke University
People needed: 19
Starts: 2014-07-01
Expected to finish: 2019-07-31
Last updated by the study team: 2020-12-03

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must have their diagnosis of high-risk AML or high-risk MDS confirmed by pathologic review of bone marrow biopsy according to WHO guidelines
Patients will be defined as high risk AML and thus eligible if they meet one or more of the following criteria:
Secondary AML (from underlying MDS or therapy related)
Presence of complex cytogenetic abnormalities (3 or more cytogenetic abnormalities), all monosomies, del 5q, del 7q, inv3, t(3;3), t(6;9), t(9;22), abn 11q23 (excluding t(9;11))
Fms-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutation positive
Age ≥ 65 years given poor outcomes even with favorable cytogenetics
Patients will be defined as high risk MDS and thus eligible if they have a MD Anderson Comprehensive Cancer MDS Risk Score ≥9
Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1,or 2; if ECOG 2, they must also have a Charlson comorbidity index of ≤5.
Subjects must be 55 years of age or older
Subjects should have a 3-5/6 HLA-matched related haploidentical donor who is evaluated and deemed able to provide DLI.
Patient should be able to provide informed consent
Subjects must have a multigated acquisition (MUGA) and /or ECHO or cardiac magnetic resonance imaging (MRI). The required minimum standards include MUGA or ECHO or cardiac MR showing an ejection fraction( EF) of 40%. Those with an EF 40-49% must also have a cardiologist consult and assist with management.
Pulmonary function tests (PFTs) with diffusing capacity of lung for carbon monoxide (DLCO) are conditional for subjects at the discretion of the physician. The required minimum standards for those who have PFTs include DLCO of 40%. Those with DLCO of 40-49% must have a pulmonologist consult and assist with management.
Subjects of all genders and races are eligible

You may not qualify if…

Pregnant or lactating women.
Patients with other major medical or psychiatric illnesses which the treating physician feels could seriously compromise tolerance to this protocol
Patients with known active central nervous system (CNS) disease
Patients with acute promyelocytic leukemia (FAB M3)

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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