A clinical trial to study the effects of Oprelvekin in patients with in prevention and treatment of chemotherapy induced thrombocytopenia in adult cancer patients.
- Conditions
- Health Condition 1: null- chemotherapy induced thrombocytopenia
- Registration Number
- CTRI/2009/091/001086
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
.Subjects of either sex, aged > 18 years
.Documented and confirmed non-myelogenous solid tumor or lymphoma on chemotherapy
.Have experienced thrombocytopenia (platelet count of <50,000 cells/ µL) in the cycle immediately prior to their entry into the study.
.Recovered to a platelet count > 1,00,000 cells/µL before initiating the Study Cycle (X+1)
.Bilirubin, SGOT & SGPT of < 2.5 ULN before initiating Study Cycle (X+1)
.Serum Creatinine of < 2 mg/dl before initiating Study Cycle (X+1)
.BUN of < 2 x ULN before initiating Study Cycle (X+1)
.Planned to be undergoing at least two more Cycles of chemotherapy with the same chemotherapy regimen without change in dose.
.ECOG performance status of < 2 at screening.
.Non-pregnant and non-nursing women. If are of child bearing potential must use effective contraceptive measures during the entire study duration.
.Subjects providing written informed consent and willing to undergo all study related procedures.
.Known allergies to E.Coli proteins
.Patient has known hypersensitivity to IL-11 or any component of Oprelvekin.
.Prior treatment with Oprelvekin / IL-11 in previous cycle
.History of rapidly progressive disease
.Received Aspirin, NSAID?s, anti-coagulant drugs (except low dose anti-coagulation to prevent catheter thrombosis) within 7 days prior to initiating Chemotherapy Cycle X+1
.Prior cumulative dose of Doxorubicin >300 mg/m2.
.History of Autoimmune Diseases, Thromboembolic disease, except catheter related thrombosis or coagulation factor deficiencies
.Severe Hypokalemia
.Existing active infection requiring systemic antibiotics at the time of enrolment
.Known HIV or HBsAg positive patients
.Patients with Leukemia, Stem Cell Transplant or Bone Marrow Transplant recipients within 60 days prior to screening
.Patients with history of Atrial Arrhythmias or congestive heart failure or patients with New York Heart Association (NYHA) Class III or IV or LVEF <45%
.History of CNS Involvement or Metastasis
.Any significant medical or surgical condition which in the opinion of investigator would interfere with the study participation.
.Pregnant and lactating women
.Any prior or current involvement of bone marrow by tumor
.Subjects who were previously included or had participated in any other clinical study within 90 days prior to the date of consent.
.Prior surgery or radiotherapy within 4 weeks prior to study entry or anticipated to require radiotherapy during the course of study
.History of prior Pelvic Irradiation
.No other active primary malignancy in last 5 years, other than the one for which chemotherapy is being instituted in the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Percentage of patients avoiding platelet transfusion (The criteria for platelet transfusion would be a reduction in platelet count below 20,000 cells/μL at any point of time during the study period)Timepoint: Any point of time during the study period)
- Secondary Outcome Measures
Name Time Method ?Number of patients avoiding platelet transfusions in each individual study cycle, as compared to pervious cycle. <br/ ><br>?Duration of thrombocytopenia, defined by time (median time) to recovery of platelet count to ≥50,000 cells/μL <br/ ><br>?The time to recovery of platelet count to ≥1,00,000 cells/μL <br/ ><br>Timepoint: ?The time to recovery of platelet count to ≥1,00,000 cells/μL <br/ ><br>