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

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

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.

Study Overview

• Status: Unknown
• Conditions: Thrombocytopenia

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;

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group rHuTPO; Patients were treated with recombinant human thrombopoietin(rHuTPO)on d2,d4,d6,d9 of chemotherapy cycle.
Group rHuIL-11; Patients were treated with recombinant human interleukin-11(rHuIL-11)on d9-d15 after chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean minimal and maximal platelet count after rHuTPO or rHuIL-11.	28days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The number of platelet transfusions after rHuTPO or rHuIL-11.	28days

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: January 18, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 22, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: NSCLC; Chemotherapy; thrombocytopenia; rhTPO
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: ShenyangSunshine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No