Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Thrombocytopenia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

rhTPO(recombinant human thrombopoietin) is given on the second, 4th and 9th day of the chemotherapy cycle in a dosage of 15000U once subcutaneously.

15000U of rhTPO(recombinant human thrombopoietin) is given subcutaneously 6 to 24 hours within the end of chemotherapy cycle, that is, the 8th day for 3 consecutive days (d9 to d11)

Recombinant human thrombopoietin injection in 15000U/ml/amp.

recombinant human thrombopoietin

Yi-Long Wu, Professor

To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)

This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy.

Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.

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

Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy With GC/GP Regimens for Non-small-cell Lung Carcinoma Using Recombinant Human Thrombopoietin (rhTPO)

To evaluate the minimum and maximum value of platelet count after chemotherapy and the value of platelet count and their D-values comparing with the baseline values

The duration when patient's platelet count remains below 50×109/L, the time (in day) when patient's platelet count increases over 75×109/L and 100×109/L, the amount of platelet infused (number of units of apheresis platelet should be transformed into number of units of platelet concentrate)

Chinese Society of Lung Cancer

Vice President of Guangdong General Hospital, Guangdong Academy of Medical Sciences

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

rhTPO 1.0 μg/kg·d subcutaneously for 7\~14 consecutive days

rhTPO

Ming Hou

Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.

The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7\~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

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

Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial

days that PLT count rebound to 30×10\^9/L, 50×10\^9/L and 100×10\^9/L, respectively, from the minimal level after the very cycle of chemotherapy.

Shandong University

Professor and Director

Immune System Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Osteosarcoma

Neuroblastoma

Lymphoma

Liver Neoplasms

Rhabdomyosarcoma

Neoplasms, Germ Cell and Embryonal

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Myosarcoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Lymphosarcoma

Germ Cells Tumors

Neuroepithelioma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Ifosfamide

Etoposide phosphate

Isophosphamide mustard

Recombinant Human Thrombopoietin

Najat C. Daw, M.D.

Life-threatening thrombocytopenia (low platelet count) and neutropenia (low white blood count) remain the major dose-limiting toxicities following chemotherapy treatment for cancer. The only remedy for thrombocytopenia at present is platelet transfusion, which is effective in preventing life-threatening hemorrhage, but may lead to other complications. Preclinical studies and studies in adults have shown recombinant human thrombopoietin (rhTPO) to be effective in stimulating platelet production. The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide, carboplatin, and etoposide in children with solid tumors and lymphomas. The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy.

Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy

A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide

St. Jude Children's Research Hospital

Symptoms and General Pathology

Recurrence

Colorectal Neoplasms

Disease Attributes

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

Hematinics

Vitamins

Irinotecan

Raltitrexed

Oprelvekin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)

Concurrent Chemoradiotherapy:

Radiation: judged according to the tumor site and radiotherapy purpose.

Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7)

Raltitrexed: 3 mg/m2 q3w

rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal)

Concurrent Chemoradiotherapy:

Radiation: judged according to the tumor site and radiotherapy purpose.

Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7)

Raltitrexed: 3 mg/m2 q3w

rhTPO 300u/kg, subcutaneous injection, qd

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

irinotecan

in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.

radiotherapy

rhIL-11 50ug/kg, subcutaneous injection, qd

rhIL-11

Ji Zhu, MD

Zhen Zhang, MD

This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.

Most patients with recurrent CRC have undergone a six-month postoperative adjuvant chemotherapy with oxaliplatin plus fluorouracil. Although the main dose-limiting side effect of oxaliplatin is neurotoxicity, with the widespread use of this drug, there are more and more reports that oxaliplatin is discontinued because of thrombocytopenia, which increases the risk of bleeding, rate of blood transfusion needs and length of stay. On the other hand, patients undergoing pelvic radiotherapy may also experience significant bone marrow suppression because flat bones such as the tibia may be exposed to high doses radiation. Low platelet counts is an urgent problem to be solved in order to give adequate quantitative radiotherapy. This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia, thus providing more evidence in clinical practice.

Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia

pathological complete response (pCR) was defined no viable cancer cell under the examination of surgical resection specimen.

Fudan University

professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy	NCT01319669	Carcinoma, Non-...	recombinant hum...	18 Years - 75 Years	Chinese Society of Lung Cancer
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia	NCT02244658	Antineoplastic ... Thrombocytopeni... Acute Myelocyti...	rhTPO	15 Years - 75 Years	Shandong University
Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy	NCT00187109	Germ Cell Tumor... Hepatic Cancer Neuroblastoma Osteosarcoma Rhabdomyosarcom...	Recombinant Hum...	- 21 Years	St. Jude Children's Research Hospital
Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia	NCT03823079	Recurrent Color... Thrombopenia	rhTPO irinotecan Raltitrexed radiotherapy rhIL-11	18 Years - 75 Years	Fudan University
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy	NCT01319669	Carcinoma, Non-...	recombinant hum...	18 Years - 75 Years	Chinese Society of Lung Cancer
Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia	NCT03823079	Recurrent Color... Thrombopenia	rhTPO irinotecan Raltitrexed radiotherapy rhIL-11	18 Years - 75 Years	Fudan University

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