Methods to reduce GVHD after bone marrow transplant for aplastic anemia

A randomized controlled trial comparing post transplant cyclophosphamide (PTCy) with cyclosporine and methotrexate (CM) as graft versus host disease (GVHD) prophylaxis and â??earlyâ?? versus â??lateâ?? cyclophosphamide administration in patients undergoing matched sibling donor transplantation (SCT) for aplastic anemia. - Not applicable

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019765

Enrollment

100

Registered

2019-06-19

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: D618- Other specified aplastic anemias and other bone marrow failure syndromes

Interventions

Intervention1: Cyclophosphamide: Inj. Cyclophosphamide 50 mg/kg IV on Day + 3 and +4 Control Intervention1: Cyclosporine: Inj. Cyclosporine x 5 mg/kg in 2 divided doses x Day -1 Inj. Methotrexate x 15

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with Aplastic Anemia above the age of 15years 2. Has a 6/6 or 9/10 HLA matched sibling or family donor 3. Willing to sign consent

Exclusion criteria

Exclusion criteria: 1. Presence of active infection at the time of HSCT 2. Use of ATG during conditioning 3. Use of bone marrow as graft source 4. Diagnosis of Fanconi anemia or other inherited bone marrow failure disorders 5. Use of any of the other conditioning regimens for AA 6. Liver abnormalities that precludes the use of methotrexate 7. Cardiac abnormalities that precludes the use of cyclophosphamide

Design outcomes

Primary

Measure	Time frame
To compare the incidence of chronic GVHD at 24 months in patients receiving prophylaxis with PTCy compared to CSA/MTXTimepoint: 24 months	—

Secondary

Measure	Time frame
1. To compare the incidence of regimen related toxicity and Day 100 mortality with early versus late cyclophosphamide administration during conditioning. 2. To compare infectious complications with the use of PTCy versus CM as GVHD prophylaxis after SCT 3. To compare immune reconstitution following the use of PTCy versus CM as GVHD prophylaxis 4. To compare Overall and GVHD free survival in patients receiving either PTCy or CM as GVHD prophylaxisTimepoint: 100 days	—

Measure

Time frame

1. To compare the incidence of regimen related toxicity and Day 100 mortality with early versus late cyclophosphamide administration during conditioning. 2. To compare infectious complications with the use of PTCy versus CM as GVHD prophylaxis after SCT 3. To compare immune reconstitution following the use of PTCy versus CM as GVHD prophylaxis 4. To compare Overall and GVHD free survival in patients receiving either PTCy or CM as GVHD prophylaxisTimepoint: 100 days

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Countries

India

Contacts

Public ContactBiju George

Christian Medical College, Vellore

biju@cmcvellore.ac.in04162282352

Outcome results

None listed

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