G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Trial Parameters
Brief Summary
Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.
Eligibility Criteria
Inclusion Criteria: * Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma * Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT) * Zubrod (ECOG) performance status \< 4 * Left ventricular ejection fraction (LVEF) \> 40% * No uncontrolled arrhythmia or unstable cardiac disease * Corrected QT interval (QTc) \< 470 ms * No symptomatic pulmonary disease, with acceptable pulmonary function tests * Serum alanine aminotransferase (ALT) \< 4 × upper limit of normal (ULN) * Total bilirubin \< 2 × upper limit of normal (ULN) Exclusion Criteria: * Intolerance to auto-HSCT * Prior exposure to other stem cell mobilizing agents * Pregnancy or lactation * Psychiatric disorders precluding participation * Positive serology for HIV (HIV-1/2), hepatitis B, or hepatitis C