Unrelated Double Umbilical Cord Blood Units Transplantation

Leukemia, Myeloid, Acute Clinical Trial

Official title:

Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01015742
• Other study ID #: HORCSCT-0902
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 17, 2009
• Last updated: May 31, 2012
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2012
• Source: Tehran University of Medical Sciences
• Contact: Ardeshir Ghavamzadeh, MD
• Phone: 84902635
• Email: ghavamza[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic, Acute
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid, Chronic
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Stem cell Transplantation
Busulfan: 3.2 mg/kg IV daily on days -7 to -4 Cyclophosphamide : 60 mg/m² daily on days -3 to -2 Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2 Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90 Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology-Oncology & SCT Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies		Until end of study	No
Secondary	Neutrophil and platelet engraftment		1 year	Yes
Secondary	Severity of acute graft-vs-host disease(GvHD		1 year	Yes
Secondary	Early transplant related mortality		100 days	Yes
Secondary	Overall and disease free survival at one years		1 year	No

External Links

•   Hematology-Oncology and Stem Cell Transplantation Research Center