Clinical trial NCT02344979: The Study of rHuTPO/rHuIL-11 in the Treatment for Chemotherapy-induced Thrombocytopenia in Patients With NSCLC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombocytopenia
Keywords: NSCLC
Chemotherapy
thrombocytopenia
rhTPO
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with NSCLC for whom treatment with gemcitabine and cisplatin or carboplatin,and Platele counts ≤ 50×109/L during Screening chemo cycle

Brief 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.

Detailed 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;

Eligibility criteria: 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

Primary outcomes:
measure: The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.
timeFrame: 28days
Secondary outcomes:
measure: 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.
timeFrame: 28days
measure: The number of platelet transfusions after rHuTPO or rHuIL-11.
timeFrame: 28days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: