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Effect of administration of Busulfan and Cyclophosphamide on liver toxicity after Allogenic Hematopoietic Stem Cell Transplantation

Evaluation of reversed administration order of busulfan and cyclophosphamide as conditioning on liver toxicity in Allogenic HSCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014060517982N1
Enrollment
30
Registered
2014-07-25
Start date
2013-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

acute leukemia. acute lymphoblastic leukemia

Interventions

Intervention 1: In control group we will use oral busulfan 1mg/kg/d (or 0.8 mg/kg/d venous busulfan)every 6 hour for 16 doses on day -8 to -5 and cyclophosphamide 40 mg/kg/d on days -4 and -2. Interve
Treatment - Drugs
In intervention group we will use cyclophosphamide 40 mg/kg/d on days -8 to -6 and oral busulfan 1mg/kg/d (or 0.8 mg/kg/d venous busulfan)every 6 hour for 16 doses on days -5 to -2.
In control group we will use oral busulfan 1mg/kg/d (or 0.8 mg/kg/d venous busulfan)every 6 hour for 16 doses on day -8 to -5 and cyclophosphamide 40 mg/kg/d on days -4 and -2.

Sponsors

Shiraz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with acute leukemia; patients that are candidate for allogenic Hematopoeitic Stem Cell Transplantation(HSCT) and Exclusion criteria: patients with disease other than acute leukemia; patients with transplantation other than myeloablative HSCT; patients without regular follow up

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Liver function test. Timepoint: before intervention , every other day during hospitalization , weekly till day +100. Method of measurement: IU/L with photometric assay.

Secondary

MeasureTime frame
Graft versus host disease and veno-occlusive disease. Timepoint: daily during hospitalization and weekly till day +100 post transplantation. Method of measurement: liver function test and Glucksberg grading.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nasrin Namdari

Shiraz University Of Medical Sciences

namdari_n@sums.ac.ir+98 71 1230 5410

Outcome results

None listed

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