TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients (TRAM-study)

TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients (TRAM-study) - TRAM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39871

Enrollment

Registered

2014-01-13

Start date

2014-06-06

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

allogeneic stemcel transplantation

Interventions

CsA monitoring and dose adjustments will be based on trough levels (arm 1) or abbreviated AUC[0-12] (arm 2).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age 18-65 inclusive * AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD) * Planned allogeneic stem cell transplantation * Related or unrelated donor with a 7/8 or 8/8 HLA match (HLA A, B, C, DRB1) or 9/10 or 10/10 MUD match * WHO performance status 0-2

Exclusion criteria

Exclusion criteria: * Renal dysfunction (serum creatinine > 150 umol/L or clearance 5% marrow blasts in case of AML, ALL, CML * Patients with EMD in case of AML, ALL, CML

Design outcomes

Primary

Measure	Time frame
Adverse drug reactions (headache, tremor, renal dysfunction, hypertension). Quality of life (QoL) will be assessed by means of validated questionnaires.	—

Secondary

Measure	Time frame
Quality of life (QoL) will be assessed by means of validated questionnaires.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)