The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC

Thrombocytopenia Clinical Trial

Official title:

The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC Receiving Gemcitabine and Cisplatin or Carboplatin Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02344979
• Other study ID #: ShenyangSunshine
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 18, 2015
• Last updated: January 22, 2015
• Start date: May 2009
• Est. completion date: June 2015

Study information

• Verified date: January 2015
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Liaoning Food Drug AdministrationUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Purpose: To evaluate the efficacy and safety of rHuTPO/rHuIL-11 in the treatment for chemotherapy-induced thrombocytopenia in patients with NSCLC receiving gemcitabine and cisplatin or carboplatin chemotherapy.

Description:

Inclusion Criteria:

1. Patients aged 18 years -75 years, male or female;

2. histologically or cytologically confirmed non-small cell lung cancer;

3. consistent with the indication of chemotherapy

4. the decrease of platelets appeared in the screen chemotherapy period and the platelet count is less than 50 * 109/ L;

5. the expected survival was more than 3 months;

6. patients must have the ability to understand and the willingness to sign a written informed consent;

7. to be able to follow the study and follow-up procedures

Exclusion Criteria:

1. pregnant or lactating women;

2. patients who had severe allergic history on biological preparation;

3. the existing serious acute infection without control;

4. Patients receiving radiotherapy;

5. more than 3 metastatic tumor of bone were found in the screening period, and the platelet count did not restore to 100 * 109/ L on the screening period on the seventeenth day of the screening period;

6. with a history of pulmonary embolism, myocardial infarction patients, thrombus history of thrombosis or activity in the past 3 months;

7. Sepsis, disseminated intravascular coagulation (DIC); hypersplenism or any other illness sickness that can exacerbate thrombocytopenia appeared in the previous cycles of chemotherapy;

8. tumor metastasis was found in the central nervous system;

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 years, Male or females

• Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin

• Platele counts = 50×109/L during Screening chemo cycle

• ECOG PS score is = 2

• The predicted life expectancy =3 months

• Written informed consent

Exclusion Criteria:

• Pregnant or nursing women

• Known history of severe anaphylactic reaction to biologics

• Uncontrolled severe infection

• History of bone or central nervous system metastasis

• History of platelet disorder

• Active bleeding

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Sunshine Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.		28days	Yes
Secondary	The time to achieve platelet count =75×109/L and =100×109/L after rHuTPO or rHuIL-11. The duration of platelet count <50×109/L after rHuTPO or rHuIL-11.		28days	Yes
Secondary	The number of platelet transfusions after rHuTPO or rHuIL-11.		28days	Yes

External Links

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