Hemato-oncologic Patients, Hematopoetic Stem Cell Transplantation, Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
Conditions
Keywords
IL-11, mobilization, hematopoetic stem cell transplantation
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.
Interventions
DRUGG-CSF+IL-11
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
rhG-CSF 5 μg/kg/day subcutaneously for 6 days
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
random assigned, two groups, one group was the novel regimen of G-CSF plus IL-11, another one is the traditional regimen G-CSF alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment) | Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first. | Granulocyte Engraftment Time: Defined as the number of days from stem cell infusion (Day 0) to the first of three consecutive days with an Absolute Neutrophil Count (ANC) \> 0.5 × 10\^9/L. Platelet Recovery Time: Defined as the number of days from stem cell infusion (Day 0) to the first day of seven consecutive days with a platelet count (PLT) ≥ 20 × 10\^9/L without transfusion support. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Adverse events are monitored from the time of enrollment (first study intervention) through the end of the study, with an expected average follow-up of 12 months. | AEs were evaluated according to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 4.0. |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS) and overall survival (OS) | PFS: From randomization to disease progression or death from any cause, whichever occurs first, through study completion, an average of 1 year. OS: From randomization to death from any cause, through study completion, an average of 1 year. |
Countries
China
Contacts
CONTACTJiexian Ma
PRINCIPAL_INVESTIGATORJiexian Ma
Huadong Hospitai, Fudan University
Outcome results
None listed