A trial to study infection reduction potential of Pegfilgrastim medicine in aplastic anemia patients
- Conditions
- Idiopathic aplastic anemia,
- Registration Number
- CTRI/2023/11/059955
- Lead Sponsor
- JIPMER
- Brief Summary
After getting approval from IEC and informed consent from participants, the study will enroll
patients with aplastic anemia meeting inclusion and exclusion criteria. Diagnosis of Aplastic
anemia is based on the following criteria: Along with hypocellular marrow, at least two of the
following should be present - haemoglobin concentration (Hb) <100 g/l, platelet count
<50 × 10 9 /l, neutrophil count <1·5 × 10 9 /l.
Severity of aplastic anemia will be assessed by The modified Camitta criteria.
severe AA (SAA);
Marrow cellularity <25% (or 25–50% with <30% residual haematopoietic cells), plus at least 2
of:
◠neutrophils <0·5 ×10 9 /l,
◠platelets <20 × 10 9 /l
◠reticulocyte count <20 × 10 9 /l (see diagnostic section for automated reticulocyte
count)
Very Severe AA (VSAA) - As for SAA but neutrophils <0·2 × 10 9 /l
Nonâ€severe AA (NSAA) -AA not fulfilling the criteria for SAA or VSAA
Once the diagnosis is confirmed, relevant details will be entered in a proforma (attached).
The administration of IST for patients diagnosed with Aplastic Anemia is based on the
decision of the treating medicine unit and not as a part of this study.
Schedule for IST is as follows
ATG is administered at a dose of 40 mg/kg/day for 4 days through a central line over 4–6 h .
Prednisolone is administered at a dose of 1mg/kg/day for 14 days, and tapered over the next
14 days.
Cyclosporine is given at a dose of 5mg/kg daily for 1 year and then tapered by 25 mg every
3 months.
Pegfilgrastim 6 mg single subcutaneous injection administered subcutaneously once during
IST to experimental group.
Patients receive packed RBC to maintain Hemoglobin above 7 g/dl and random donor
platelets in case of bleeding or to maintain count above 10,000. (6) After discharge , they will
be followed up monthly at least for months
Primary efficacy:
Measured as incidence of febrile neutropenia and time to development of febrile neutropenia
in peg filgastrim group v/s control group
Secondary efficacy:
PGRMC & Intramural Research Fund Committee Application Form (Version 1.0, 15 th Nov 2020)
9
Measured as neutrophil response at the end of 1, 3, 6 months and the best overall neutrophil
response. A complete neutrophil response is defined as ANC ≥1.5x 109 /l
A partial neutrophil response as ANC ≥ 0.5 x 109 /l but < 1.5 · 109 /l. Patients will be
classified as responders if they achieved a complete or partial response which is confirmed
by 2 consecutive values. Secondary efficacy parameters also include the survival status till
6months of enrollment
Tertiary efficacy:
Tertiary efficacy parameters include platelet and reticulocyte recovery. Platelet response will
be examined in patients with an untransfused baseline platelet count < 20 x109 /l and
erythrocyte response examined in those whose Hb is <7g/dl. A complete platelet response is
defined as a count of> 150 x109 /l, while a partial response is defined as a count of 20 x109
/l but < 150x 109 /l. Complete erythrocyte recovery was defined as a haemoglobin value of>
10 g/dl, and partial recovery is Hb of 7 to 10g/dl without transfusion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 80
BONE MARROW PROVEN DIAGNOSIS OF APLASTIC ANEMIA.
- 1.Patients who have received ATG elsewhere 2.Patients with inherited bone marrow syndromes .
- 3.Patients with Hepatitis B or Hepatitis C.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of febrile neutropenia (measured by ANC count) in peg filgastrim group v/s control group. ABSOLUTE NEUTROPHIL COUNT WILL BE MEASURED AT BASELINE (0)AT THE TIME OF ADMISSION, AT 1 WEEK, 4 WEEKS, 12 WEEKS
- Secondary Outcome Measures
Name Time Method TO ASSESS RESPONSE 1,3, 6 MONTHS
Trial Locations
- Locations (1)
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
JIPMER🇮🇳Pondicherry, PONDICHERRY, IndiaDRAPARNASPrincipal investigator8098578542aparnasudhakaran2017@gmail.com