PRE-emptive therapy of acute Graft Versus Host Disease according to specific proteomic patterns after allogeneic haematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN03911524

Enrollment

580

Registered

2007-12-19

Start date

2008-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Graft versus host disease after allogeneic haematopoietic stem cell transplantation Injury, Occupational Diseases, Poisoning Failure and rejection of transplanted organs and tissues

Interventions

Experimental intervention: Pre-emptive immunosuppressive treatment (daily 2 mg methylprednisone/kg body weight [BW]) immediately at occurrence of an aGvHD grade II-specific proteome pattern. Control

increase of symptoms in severity after three days, no change for seven days, intermediate response for 14 days). In case of clinical aGvHD (greater than grade II) unblinding is necessary: the placeb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT) 2. Informed consent

Exclusion criteria

Exclusion criteria: 1. Severe infections at the time of aGvHD-pattern positivity 2. No informed consent

Design outcomes

Primary

Measure	Time frame
Occurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.	—

Secondary

Measure	Time frame
1. Increased overall survival in treatment group (day +365) 2. Reduction of severity of aGvHD (day +120) Scientific endpoints (measured at end of study: three years): 1. Differentiation of aGvHD grade II to IV according to polypeptide markers 2. Organ specific aGvHD pattern 3. Generation of proteomic patterns for steroid resistant GvHD (will be acquired during the study) 4. Normalisation of aGvHD proteome pattern in response to treatment	—

Measure

Time frame

1. Increased overall survival in treatment group (day +365) 2. Reduction of severity of aGvHD (day +120) Scientific endpoints (measured at end of study: three years): 1. Differentiation of aGvHD grade II to IV according to polypeptide markers 2. Organ specific aGvHD pattern 3. Generation of proteomic patterns for steroid resistant GvHD (will be acquired during the study) 4. Normalisation of aGvHD proteome pattern in response to treatment

—

Countries

Germany

Outcome results

None listed

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