Adoptive Transfer of Haplo-identical DLI for AML and MDS
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 9/22/2018 |
| Start Date: | July 2014 |
| End Date: | July 2020 |
Safety and Efficacy of Chemotherapy Combined With Adoptive Transfer of Human Leukocyte Antigen (HLA)-Haploidentical Donor Lymphocyte Infusion (DLI) in Older Patients With Righ-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
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.
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.
Inclusion Criteria:
1. 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
2. Patients will be defined as high risk AML and thus eligible if they meet one or more
of the following criteria:
1. Secondary AML (from underlying MDS or therapy related)
2. 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))
3. Fms-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutation
positive
4. Age ≥ 65 years given poor outcomes even with favorable cytogenetics
3. Patients will be defined as high risk MDS and thus eligible if they have a MD Anderson
Comprehensive Cancer MDS Risk Score ≥9
4. 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.
5. Subjects must be 55 years of age or older
6. Subjects should have a 3-5/6 HLA-matched related haploidentical donor who is evaluated
and deemed able to provide DLI.
7. Patient should be able to provide informed consent
8. 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.
9. 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.
10. Subjects of all genders and races are eligible
Exclusion Criteria:
1. Pregnant or lactating women.
2. Patients with other major medical or psychiatric illnesses which the treating
physician feels could seriously compromise tolerance to this protocol
3. Patients with known active central nervous system (CNS) disease
4. Patients with acute promyelocytic leukemia (FAB M3)
We found this trial at
1
site
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
