Thiotepa in autologous stem cell transplantation (ASCT): A non-interventional, prospective study to assess safety and efficacy of Thiotepa-based high dose chemotherapy (HDCT) prior to autologous stem cell transplantation in adults with B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005719

Enrollment

150

Registered

2014-02-24

Start date

2013-12-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma C81 C82 C83 C84 C85

Interventions

Group 1: - Thiotepa + BCNU +/- Etoposid - Thiotepa + Etoposid + AraC + Melphalan (TEAM) - Thiotepa + other

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - signed informed consent form - age = 18 years - patients with a documented B- or T-cell lymphoma (non-Hodgkin lymphoma or Hodgkin lymphoma) with or without CNS involvement or with primary CNS lymphoma - first autologous stem cell transplantation (ASCT) - Thiotepa-based high dose chemotherapy prior to ASCT

Exclusion criteria

Exclusion criteria: Contraindications: Hypersensitivity to the active substance. Pregnancy and lactation Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines

Design outcomes

Primary

Measure	Time frame
Therapy associated organ toxicity up to day 30 and day 100 after ASCT.	—

Secondary

Measure	Time frame
Safety criteria: - occurrence of AEs from day 1 of high dose chemotherapy until day 100 after ASCT - occurrence of ADRs and SAEs from day 1 of high dose chemotherapy until 1 year after ASCT - duration of hospitalization - Recovery A (1st day granulocytes = 500/µL or 1st day leucocytes = 1.000/µL) and Recovery B (1st day thrombocytes = 20.000/µL) - transplantation related mortality (TRM) at day 30 and day 100 after ASCT - cumulative incidence of mortality without recurrence (NRM) 1 year after ASCT Efficacy criteria: - Overall response rate (ORR) at day 100 und after 1 year (CCR, CR, PR, SD, PD, Switchrate PR=>CR) - progression free survival (PFS) 1 year after ASCT - cumulative incidence of recurrence 1 year after ASCT - overall survival (OS) 1 year after ASCT	—

Measure

Time frame

Safety criteria: - occurrence of AEs from day 1 of high dose chemotherapy until day 100 after ASCT - occurrence of ADRs and SAEs from day 1 of high dose chemotherapy until 1 year after ASCT - duration of hospitalization - Recovery A (1st day granulocytes = 500/µL or 1st day leucocytes = 1.000/µL) and Recovery B (1st day thrombocytes = 20.000/µL) - transplantation related mortality (TRM) at day 30 and day 100 after ASCT - cumulative incidence of mortality without recurrence (NRM) 1 year after ASCT Efficacy criteria: - Overall response rate (ORR) at day 100 und after 1 year (CCR, CR, PR, SD, PD, Switchrate PR=>CR) - progression free survival (PFS) 1 year after ASCT - cumulative incidence of recurrence 1 year after ASCT - overall survival (OS) 1 year after ASCT

—

Countries

Germany

Contacts

Public ContactDietmar Schröder

RIEMSER Pharma GmbH

schroederd@riemser.com038351 76 121

Outcome results

None listed

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