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Safety and Efficacy Trial of Recombinant Human Granulocyte Colony Stimulating Factor (GCSF)

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ClinicalTrials.gov Identifier: NCT00776165
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : February 3, 2010
Sponsor:
Information provided by:
Shantha Biotechnics Limited

Study Description
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Brief Summary:

A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.

Adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ECOG status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study.

Treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups.

Group 1: Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha)

  • Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Group 2: Neupogen (rhG-CSF)
  • Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier Primary End Point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 109/L on the same day of the fever or the day after)in the two treatment groups.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Neutropenia Biological: Recombinant Human GCSF (Shantha Biotechnics Limited) Biological: Neupogen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
Study Start Date : October 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF)(Shantha) Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
 Biological: Recombinant Human GCSF (Shantha Biotechnics Limited)
Dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
Active Comparator: 2
Neupogen (rhG-CSF) Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier
 Biological: Neupogen
Dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till Neutrophil count of 10,000/mm3 is reached whichever is earlier


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of > 38°C twice in a 12-hour period and absolute neutrophil count < 0.5 x 10e9/L on the same day of the fever or the day after. [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. Percentage of patients developing adverse events and/ or changes in laboratory values. [ Time Frame: End of study ]
  2. Incidence of neutropenia defined as absolute neutrophil count < 0.5 x 10e9/L not associated with fever [ Time Frame: End of study ]
  3. Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of either sex aged 18 yrs or more
  • Patients diagnosed having any malignancy (except myeloid malignancies and myelodysplastic syndromes) receiving standard combination chemotherapy.
  • Patients experiencing neutropenia (absolute neutrophil count < 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs.
  • Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group).

Exclusion Criteria:

  • Patients unwilling to give informed consent or unable to follow study procedures
  • Patients requiring autologous or allogenic stem cell transplantation.
  • Patients having active infection
  • Patients who have taken antibiotics or colony stimulation factor within the previous 10 days
  • Patients who have clinically significant uncontrolled medical illness except malignancy
  • Patients having renal impairment (serum creatinine > 1.5 times the upper normal limit) and abnormal liver function (bilirubin > 5 times the upper limit of normal)
  • Pregnant or lactating women
  • Patients who have involvement of bone marrow
  • Patients receiving simultaneous radiotherapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776165


Locations
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India
Indo American Cancer Institute and Research Centre
Hyderabad, Andhra Pradesh, India, 500034
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500034
Vedanta Institute of Medical Sciences
Ahmedabad, Gujrat, India, 380009
Lakeshore Hospital and Research Center
Cochin, Kerala, India, 682404
Regional Cancer Centre
Trivandrum, Kerala, India, 695011
Seth Ramdas Shah Memorial Hospital
Pune, Maharashtra, India, 411016
SMS Medical College and Hospital
Jaipur, Rajasthan, India, 302004
Sponsors and Collaborators
Shantha Biotechnics Limited
Investigators
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Study Director: Raman Rao, MD Shantha Biotechnics Limited, Hyderabad, India
More Information
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Responsible Party: Dr. Raman Rao, Shantha Biotechnics Limited, Hyderabad, India
ClinicalTrials.gov Identifier: NCT00776165    
Other Study ID Numbers: SBL/GCSF/N/2007/0100
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases