Chemotherapy-induced Thrombocytopenia Clinical Trial
Official title:
Multicenter, Randomized Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 to Prevent Chemotherapy-induced Thrombocytopenia in Cancer Patients Receiving Chemotherapy.
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05969158 -
Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT03362177 -
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
|
Phase 3 | |
| Recruiting |
NCT05554913 -
Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia
|
Phase 2/Phase 3 | |
| Completed |
NCT05688306 -
To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
|
||
| Completed |
NCT00283439 -
A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06099925 -
The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies
|
Phase 2 | |
| Completed |
NCT03471078 -
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
|
Phase 3 | |
| Active, not recruiting |
NCT03976882 -
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.
|
Phase 3 | |
| Recruiting |
NCT05772546 -
Avatrombopag vs. Placebo for CIT in GI Malignancies
|
Phase 2 | |
| Not yet recruiting |
NCT05864014 -
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
|
Phase 3 | |
| Terminated |
NCT01345214 -
A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia
|
Phase 1 | |
| Recruiting |
NCT05236582 -
Herombopag for Chemotherapy-induced Thrombocytopenia
|
Phase 2 | |
| Not yet recruiting |
NCT05944211 -
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
|
Phase 2 | |
| Withdrawn |
NCT03343847 -
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma.
|
Phase 3 | |
| Completed |
NCT05851027 -
Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT03049774 -
A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
|
N/A | |
| Recruiting |
NCT03937154 -
Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
|
Phase 3 | |
| Recruiting |
NCT05218226 -
Avatrombopag for Chemotherapy-induced Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT04600960 -
Eltrombopag for Chemotherapy-induced Thrombocytopenia
|
Phase 2 | |
| Completed |
NCT00413283 -
Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
|
Phase 2 |