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

Non‐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.