Unrelated Double Umbilical Cord Blood Units Transplantation

This study is currently recruiting participants.
Verified May 2012 by Tehran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01015742
First received: November 17, 2009
Last updated: May 31, 2012
Last verified: May 2012

November 17, 2009
May 31, 2012
November 2009
December 2012   (final data collection date for primary outcome measure)
To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01015742 on ClinicalTrials.gov Archive Site
  • Neutrophil and platelet engraftment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Severity of acute graft-vs-host disease(GvHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Early transplant related mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Overall and disease free survival at one years [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Unrelated Double Umbilical Cord Blood Units Transplantation
Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Myeloid, Chronic
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.

Experimental: Experimental
Stem cell Transplant using two unrelated umbilical cord blood units.
Intervention: Drug: Stem cell Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 50 Years
No
Contact: Ardeshir Ghavamzadeh, MD 84902635 ext +98-21 ghavamza@sina.tums.ac.ir
Iran, Islamic Republic of
 
NCT01015742
HORCSCT-0902
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Amir Ali Hamidieh, MD Hematology-Oncology and SCT Research Center
Tehran University of Medical Sciences
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP