Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy of ex vivo generated megakaryocytic progenitor cells (MPs) in prophylaxis and treatment of thrombocytopenia caused by chemotherapy in patients with acute leukemia (AL).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia

NCT02244658

Antineoplastic Adverse Reaction Thrombocytopenia Acute Myelocytic Leukemia

UNKNOWN PHASE3

A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.

NCT06534255

Refractory Thrombocytopenia

ACTIVE_NOT_RECRUITING PHASE1

Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy

NCT01319669

Carcinoma, Non-Small-Cell Lung

TERMINATED PHASE2/PHASE3

Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT

NCT01379391

Allogeneic Hematopoietic Stem Cell Transplantation Myeloablative Delayed Platelet Engraftment

UNKNOWN PHASE4

Eltrombopag for Chemotherapy-induced Thrombocytopenia

NCT04600960

Chemotherapy-induced Thrombocytopenia Eltrombopag

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Thrombocytopenia is a common and potentially fatal complication of chemotherapy and hematopoietic stem cell transplantation. Owing to the short storage time and increased demand of platelets from unrelated donors, a constant shortage in the supply of platelets has become an important medical and society challenge. Therefore, investigation of alternative sources of platelets would be beneficial.

Hematopoietic stem cells (HSCs) can be used to generate functional megakaryocytic progenitors (MPs), megakaryocytes, and platelets on a large scale. Functional MPs and platelets have successfully been produced in vitro from CD34+ hematopoietic cells from bone marrow, cord blood, and peripheral blood. Several studies have reported that transplantation of in vitro auto-producing MPs can promote platelet recovery after high-dose therapy and HSC transplantation.

Umbilical cord blood is an abundant source of HSCs. In vitro large scale production of MPs from cord blood could represent an effective platelet substitute. Theoretically, the additional transplantation of ex vivo generated progenitor and post-progenitor cells might lead to the production of sufficient numbers of mature functional cells within a few days after transplantation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hematological Diseases Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MPs

MPs will be intravenously infused within 48 hours after chemotherapy. During the study period, patients can receive platelet infusion but can not receive platelet stimulating factors.

Group Type EXPERIMENTAL

MPs

Intervention Type BIOLOGICAL

MPs are generated from cord blood using a combination of cytokines.

Non-MPs

Patients can receive platelet infusion but can not receive platelet stimulating factors.

Group Type ACTIVE_COMPARATOR

thrombopoietin (TPO) and interleukin-11

Intervention Type DRUG

Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MPs

MPs are generated from cord blood using a combination of cytokines.

Intervention Type BIOLOGICAL

thrombopoietin (TPO) and interleukin-11

Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age：14-65 years
* achieve complete remission of acute leukemia
* the first course of consolidation chemotherapy
* ECOG grades 0 or 1
* expected survival time ≥ three months
* Subjects (or their legally acceptable representatives) must have signed an informed consent document.

Exclusion Criteria

* cardiac dysfunction (particularly congestive heart failure), hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal), renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No