Phase 2
Completed N=63
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
leukemia · Acute Erythroid Leukemia · Acute Myeloid Leukemia · Blasts Under 20 Percent of Bone Marrow Nucleated Cells
Source: ClinicalTrials.gov NCT01823198 ↗
Enrolled (actual)
63
Serious AEs
26.2%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants Who Experienced Dose-limiting Toxicities (DLT) — 2; 1; 0; 0 Participants
Summary
This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-limiting Toxicities (DLT) |
2; 1; 0; 0; 0; 0 | — |
| SECONDARY Overall Survival |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Grade 3 Toxicities |
2; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Acute myeloid leukemia who fail to achieve complete remission with one course of induction chemotherapy or after relapse; patients must have less than 20% bone marrow or peripheral blood blasts
- Acute myeloid leukemia in first remission with any of the following high risk features defined as:
- Adverse cytogenetics: -5, deletion (del) 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 or complex karyotype (> 3 abnormalities)
- Preceding myelodysplastic or myeloproliferative syndrome
- Presence of high risk molecular abnormalities including FLT3 mutations, DNMT3A, TET2; ras; kit
- French-American-British (FAB) monosomy (M)6 or M7 classification
- Treatment related acute myeloid leukemia (AML)
- Residual cytogenetic or molecular abnormalities
- Myelodysplastic syndromes with intermediate, high or very high risk Revised International Prognostic Scoring System (R-IPSS) score, chronic myelomonocytic leukemia (CMML) or therapy related myelodysplastic syndromes (MDS)
- Chronic myeloid leukemia (CML) which:
- Failed to achieve a cytogenetic remission to tyrosine kinase inhibitor treatment or has a cytogenetic relapse
- Has ever been in accelerated phase or blast crisis
- Patient must have an identified HLA (A,B,C,DR) compatible related or unrelated donor who is age 16 years of age or older and weighs at least 110 pounds for the stem cell donation
- Zubrod performance status 0 to 2 or Karnofsky of at least 60
- Left ventricular ejection fraction >= 45%; no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease
- Forced expiratory volume in one second (FEV1) >= 50% of expected, corrected for hemoglobin
- Forced vital capacity (FVC) >= 50% of expected, corrected for hemoglobin
- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of expected, corrected for hemoglobin
- Bilirubin = 1 L
- Patients who are known to be human immunodeficiency virus (HIV)-seropositive
- Pregnancy: positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
- Women of child bearing potential not willing to use an effective contraceptive measure while on study
- Patients who are known to have allergy to mouse proteins
Data sourced from ClinicalTrials.gov (NCT01823198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.