phase IV single arm, open-label, multicentre study the incidence of treatment emergent adverse events in chemotherapy induced neutropenia patients

A phase IV, prospective, single arm, open-label, multicentre study to assess the safety and efficacy of PEG-Neutrogen (pegfilgrastim) in prevention of chemotherapy-induced neutropenia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/02/103432

Enrollment

200

Registered

2026-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D708- Other neutropenia

Interventions

Intervention1: Pegfilgrastim 6mg: Administer subcutaneously single dose of PEG-Neutrogen (6 mg) 24 - 30 hrs after chemotherapy Control Intervention1: NIL: Not applicable as it is a single arm study

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged between 18 to 65 years. 2. Patients with histologically confirmed tumors (breast cancer, lung cancer, Non-Hodgkin Lymphoma, ovarian cancer, cervical cancer). 3.Patients who are planned to receive myelosupresive chemotherapy regimen (which is known to induce severe neutropenia). 4. Patients with baseline ANC of greaterthan1.5 x 109/L and platelet count greaterthan 100 x 109/L. 5.Patients with hemoglobin greaterthan9 g/dl; WBC greaterthan3,000/cu mm. 6.Patients with albumin greaterthan 3.0 g/dl. 7.Performance status as per ECOG (Eastern Cooperative Group) score 0, 1 or 2. 8.Patients with life expectancy more than 2 months. 9.Patients scheduled to undergo chemotherapy at least for 3 cycles. 10.Patients who are available for 15 days during each post chemotherapy cycle. 11.Patients who are willing to give the consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women or patients planning to become pregnant. 2.Known allergic reactions to study medications. 3.Patients with myelodysplastic syndrome, acute lymphoblastic or myeloblastic leukemia, lymophoblastic lymphoma, myeloma or severe pneumonia, hypotension, multi organ dysfunction. 4.Patients with prior exposure to G-CSF or GM-CSF or to its pegylated products. 5. Myelotoxic concomitant treatment such as chloramphenicol, sulphmethoxarate, immunomodulating agents, interferons during 10 days before randomization. 6.Central nervous system metastases. 7.Patients who had an immediate or concurrent exposure to radio therapy and surgery. 8. Abnormal cardiovascular, hepatic and renal laboratory parameters that are deemed to be clinically significant as per investigator. 9.Known cases of sickle cell anemia. 10.History of AIDS, or HIV positive, active hepatitis and active tuberculosis.

Design outcomes

Primary

Measure	Time frame
1.Incidence of treatment emergent adverse events.Timepoint: 63 days	—

Secondary

Measure	Time frame
1. Duration of severe neutropenia (ANC lessthan500 cells/ l) in cycle 1. 2. Duration of severe neutropenia (ANC lessthan500 cells/ l) in cycles 2&3. Timepoint: Day 21, 42, 63	—

Countries

India

Contacts

Public ContactDr Hemanth Nandigala

Virchow Biotech Private Limited

hnandigala@gmail.com9866911717

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026