Cyclophosphamide as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation for aplastic anemia (AA)

A pilot study of using single agent post transplantation cyclophosphamide as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation for aplastic anemia (AA)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001480

Enrollment

Registered

2010-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- APLASTIC ANEMIA

Interventions

Intervention1: cyclophosphamide: 50mg/kg Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Eligibility

Inclusion criteria

Inclusion criteria: Patients with aplastic anemia who have a HLA identical donor Both adults and children will be included in this study

Exclusion criteria

Exclusion criteria: Patients with aplastic anemia who have an underlying constitutional disorder such as Fanconi?s anemia, Dyskeratosis congenita Patients with active infection which precludes the use of the specific conditioning regimen or GVHD prophylaxis

Design outcomes

Primary

Measure	Time frame
determine whether the use of single agent post transplantation cyclophosphamide as GVHD prophylaxis will reduce the incidence of acute and chronic GVHD in patients undergoing allogeneic HSCT for aplastic anemia Timepoint: Patients will be monitored for a period of 2 years after transplant.	—

Secondary

Measure	Time frame
a) To study the toxicity of using post-transplant cyclophosphamide as single agent for GVHD prophylaxis b) Study the kinetics of neutrophil and platelet engraftment. c) Study the incidence of graft rejection and overall survival following HSCT Timepoint: Patients having transplant for aplastic anemia and willing to give consent for the protocol will be included in the study. They will receive 2 doses of cyclophosphamide on Day 3 and 4 after transplant instead of the standard medicines. Patients will then be followed up routinely to look for onset of GVHD and monitor for complications of cyclophosphamide. Patients will be monitored for a period of 2 years after transplant.	—

Measure

Time frame

a) To study the toxicity of using post-transplant cyclophosphamide as single agent for GVHD prophylaxis b) Study the kinetics of neutrophil and platelet engraftment. c) Study the incidence of graft rejection and overall survival following HSCT Timepoint: Patients having transplant for aplastic anemia and willing to give consent for the protocol will be included in the study. They will receive 2 doses of cyclophosphamide on Day 3 and 4 after transplant instead of the standard medicines. Patients will then be followed up routinely to look for onset of GVHD and monitor for complications of cyclophosphamide. Patients will be monitored for a period of 2 years after transplant.

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Countries

India

Contacts

Public ContactDr BIJU GEORGE

THE Dr. M.G.R MEDICAl university

biju@cmcvellore.ac.in2282352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 25, 2026