Efficacy of Tiothepa in hematopoietic stem cell transplantation in acute lymphoblastic leukemia patients

Evaluation of the efficacy of a tiotepa-based regimen for allogeneic transplantation in patients with acute lymphoblastic leukemia: a prospective single arm study.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N39

Enrollment

Registered

2024-05-12

Start date

2024-04-20

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

acute lymphoblastic leukemia. Acute lymphoblastic leukemia [ALL]

Interventions

Intervention group: Fludarabin (ACTOVERCO) 30 mg/m2, Day -7 to -4, Busulfan (Nanoalvand) 3.2 mg/kg/D, Day -7 and -4, Thiotepa (Nanoalvand) 5 mg/kg/D IV day -3 and -2..

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: patients with acute lymphoblastic leukemia

Exclusion criteria

Exclusion criteria: symptomatic coronary artery disease karnofsky Performance Score < 60 patients with uncontrolled bacterial, viral or fungal infection females who are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Overall survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique.	—

Secondary

Measure	Time frame
Relapse incidence. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing bone marrow biopsy and monthly lab tests in outpatient clinique.;Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of chronic graft versus host disease. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Transplant Related Mortality. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.	—

Measure

Time frame

Relapse incidence. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing bone marrow biopsy and monthly lab tests in outpatient clinique.;Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of chronic graft versus host disease. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Transplant Related Mortality. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeyla Sharifi Aliabadi

Tehran University of Medical Sciences

ctu@sina.tums.ac.ir00982288004140

Outcome results

None listed

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