Prophylaxis of relapse with high dose cyclophosphamide or donor lymphocyte infusion (DLI) after haploidentical stem cell transplantation in high risk acute leukemia

Comparison of post-transplantation high dose cyclophosphamide versus Donor lymphocyte infusion (DLI) as relapse prophylaxis after haploidentical stem cell transplantation in high risk acute leukemia: A prospective randomized study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201208041030N11

Enrollment

Registered

2012-08-26

Start date

2009-11-22

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

Condition 1: Acute myelblastic leukaemia. Condition 2: Acute lymphoblastic leukaemia [ALL]. Acute myelblastic leukaemia Acute lymphoblastic leukaemia [ALL]

Interventions

Intervention 1: Donor lymphocyte infusion (DLI) from donor after subcutaneous granulocyte colony-stimulating factor (G-CSF) at day +30 with average cell dose 4×10^8 mononuclear cells (MNC)/kg (2.5-6×1

Treatment - Drugs

Donor lymphocyte infusion (DLI) from donor after subcutaneous granulocyte colony-stimulating factor (G-CSF) at day +30 with average cell dose 4×10^8 mononuclear cells (MNC)/kg (2.5-6×10^8 MNC/kg)

Cyclophosphamide 50 mg/kg at day +3

Eligibility

Sex/Gender

All

Age

17 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diagnosis of ALL or AML; Status of first complete remission (CR1) in high risk patients and second complete remission (CR2) for others; Age: 17-50; Karnofsky score 70-100; Life expectancy: 12 months; No Full matched donor (Related, Unrelated and Cord Blood); No candidate for autologous transplantation; Live enzyme 45% and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) greater than 45%; Human Immunodeficiency Virus (HIV) negative; No addiction. Exclusion criteria: Pregnancy; Breast feeding.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Relapse rate after transplantation. Timepoint: One year after transplantation. Method of measurement: Bone marrow examination.	—

Secondary

Measure	Time frame
One year overall survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;One year disease free survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of chronic GVHD. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of treatment related mortality. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of acute GVHD. Timepoint: Three month after transplantation. Method of measurement: Examination and following treatment.	—

Measure

Time frame

One year overall survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;One year disease free survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of chronic GVHD. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of treatment related mortality. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of acute GVHD. Timepoint: Three month after transplantation. Method of measurement: Examination and following treatment.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Fakharian

Hematology-Oncology & SCT Research Center

horcbmt@tums.ac.ir+98 21 8490 2635

Outcome results

None listed

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