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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2009

Last Updated Date

May 31, 2012

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Unrelated Double Umbilical Cord Blood Units Transplantation

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Leukemia, Myeloid, Chronic

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Experimental

Stem cell Transplant using two unrelated umbilical cord blood units.

Intervention: Drug: Stem cell Transplantation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ardeshir Ghavamzadeh, MD

84902635 ext +98-21

ghavamza@sina.tums.ac.ir

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01015742

Other Study ID Numbers ^ICMJE

HORCSCT-0902

Has Data Monitoring Committee

Yes

Responsible Party

Tehran University of Medical Sciences

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Amir Ali Hamidieh, MD

Hematology-Oncology and SCT Research Center

Information Provided By

Tehran University of Medical Sciences

Verification Date

May 2012

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

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