Clinical trial NCT01015742: Unrelated Double Umbilical Cord Blood Units Transplantation
Official title: Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Leukemia, Myeloid, Chronic
Keywords: AML
ALL
CML
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Hematologically \& Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission
* Aged 1 year to 50 years
* Absence of HLA compatible related or other related donor.
* Availability of suitable UCB units.
* karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) : 80- 100
* Adequate renal function defined as:Serum creatinine \<1.5 x normal,
* Adequate liver function defined as:Total bilirubin \<1.5 x normal, or SGOT (AST) or SGPT (ALT) \<3.0 x normal
* Adequate cardiac function defined as: Ejection fraction \>50% by echocardiogram.
* Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air

Exclusion Criteria:

* Age: \< 1year or \> 50 year
* Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor
* karnofsky performance score (\> 12 yr) or lansky play performance(\<12 yr) \< 80
* HIV positive patients.
* Female patients who are pregnant or breast feeding
* Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
* Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
* Serious psychiatric/ psychological disorders
* Absence of /inability to provide informed consent
* Clinical or Paraclinical evidence of CNS or PNS involvement

Primary outcomes:
measure: To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
timeFrame: Until end of study
Secondary outcomes:
measure: Neutrophil and platelet engraftment
timeFrame: 1 year
measure: Severity of acute graft-vs-host disease(GvHD
timeFrame: 1 year
measure: Early transplant related mortality
timeFrame: 100 days
measure: Overall and disease free survival at one years
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
affiliation: Hematology-Oncology and SCT Research Center
name: Amir Ali Hamidieh, MD
role: PRINCIPAL_INVESTIGATOR
References: