A phase 2 trial of a preventative treatment (cyclophosphamide) for graft-versus-host disease after matched (HLA-identical) allogeneic donor transplant using less intensive chemotherapy

A phase 2 trial of cyclophosphamide as prophylaxis for graft-versus-host disease after HLA-identical allogeneic donor transplantation using reduced intensity conditioning therapy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001154796

Acronym

PT CYCLO

Enrollment

Registered

2013-10-16

Start date

2014-03-01

Completion date

2016-03-01

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study is evaluating whether treatment with cyclophosphamide can prevent the development of graft-versus-host disease after matched (HLA-identical) allogeneic donor transplant in patients with a haematological malignancy. Who is it for? You may be eligible to join this study if you are aged between 15-70 years and have been diagnosed with a high risk haematological malignancy suitable for treatment with an allogeneic transplant. You should have a suitable HLA-matched related donor or unrelated volunteer donor identified and available. Study details All participants in this study will receive 50mg/kg of Cyclophosphamide on Day 3 and Day 4 post allogeneic transplant. This drug will be administered intravenously (i.e. into the vein) over 1 hour. Participants will be followed up at 100 days, 1 year, and 2 years post transplant in order to determine rates of graft-versus-host disease. This will be compared to data collected previously in patients who received transplants using Reduced Intensity Condition (RIC) therapy and unrelated donors to determine relative effectiveness.

Interventions

Cyclophosphamide 50 mg/kg on days +3 and +4 post transplant (2 doses)by intravenous infusion over 1 hour

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Age 15-70 years 2. High risk hematological malignancy suitable for treatment with an allogeneic transplant (acute leukaemia in first remission with poor risk cytogenetics or unfavourable gene mutation profile, or in second or subsequent remission, chronic myeloid leukaemia in first chronic phase not responding to tyrosine kinase inhibitor therapy, poor risk myelodysplastic syndrome, Hodgkin or non-Hodgkin lymphoma failing conventional therapy). 3. Suitable HLA-matched related donor (6/6 match for A, B, DRB1) or unrelated volunteer donor (8 locus match for A, B, C, and DRB1 at allelic level) identified and available.

Exclusion criteria

1. Serious organ dysfunction or uncontrolled infection 2. HIV positive 3. Uncontrolled hepatitis B or C.

Outcome results