This phase I/II study the side effects and efficacy of natural killer cells after donor stem cell transplant and how they treat patients with myeloid malignancies or lymphoproliferative disorders. Investigators expanded NK cells ex vivo with a non-feeder cell regimen to avoid the risk of infusion of feeder cells with expanded NK cells. Investigators infuse NK cells after myeloablative conditioning therapy. These cells may help decrease relapse of malignant disease, severe graft versus host disease, reactivation of certain viruses, and, therefore, prolong the survival of participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
MYELOABLATIVE CONDITIONING REGIMEN: Patients with myeloid malignancies receive busulfan on days -7 to -4, fludarabine IV over 1 hour on days -7 to -3, cytarabine IV over 4 hours on days -7 to -3. Patients with lymphoproliferative disorders receive busulfan on day -7 to -4, cladribine IV over 1 hour on days -7 to -3, gemcitabine IV over 4 hours on days -7 and -3. TRANSPLANT: Patients undergo PBSC transplant on day 0. POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, cyclosporin IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO BID beginning on day 5 for 30 days. NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGMaximum tolerated doses (MTD) of natural killer (NK) cells
Primary Outcome Measures
Time frame: Up to day 70 post-transplant
100-day treatment related mortality
Will be defined as death due to any cause without disease recurrence within 100 days post stem cell transplant (SCT). The method of Thall and Sung will be used, based on an historical rate of 35%.
Time frame: Up to 100 days post-transplant
Overall survival
Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests.
Time frame: Up to 2 years post-transplant
Relapse-free survival
Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests.
Time frame: Up to 2 years post-transplant
Time to engraftment
Will be estimated using the Kaplan-Meier method, and distributions will be compared using log-rank tests.
Time frame: Up to 2 years post-transplant
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