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To study the effect of post-transplant cyclophosphamide pharmacology with transplant outcomes in patients undergoing haploidentical hematopoietic stem cell transplantation

To study the effect of post-transplant cyclophosphamide pharmacokinetics and pharmacogenetics with transplant outcomes and immune reconstitution in patients undergoing haploidentical hematopoietic stem cell transplantation for acute leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/08/015152
Enrollment
50
Registered
2018-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: null- Patients of acute leukemia

Interventions

None listed

Sponsors

Department of Internal Medicine
Lead Sponsor
Department of Phrmacology
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients receiving either myeloablative or reduced intensity conditioning. 2. Patients receiving post-transplant cyclophosphamide as a part of haploidentical transplantation. 3. Patients consenting for study.

Exclusion criteria

Exclusion criteria: 1. Patients not willing for haploidentical hematopoietic cell transplantation 2. Patients who are unable to follow up for one year. 3. Patients not a candidate for haploidentical HCT or as deemed unfit for HCT by treating physician as per established unit protocol 4. Patients other than acute leukemia undergoing haploidentical HCT

Design outcomes

Primary

MeasureTime frame
Progression free survival Regimen related toxicity Graft versus Host disease Overall survival Timepoint: 100 days after transplant, 1 year post transplant—

Secondary

MeasureTime frame
Immune Reconstitution will be assessed.Timepoint: At 4th, 12th,24th and 51 week after transplant.—

Countries

India

Contacts

Public ContactKripa Shanker

Post Graduate Institute of Medical Education and Research

deepesh.kem@gmail.com9417770112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026