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Unrelated Double Umbilical Cord Blood Units Transplantation

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Stem cell Transplantation

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring AML, ALL, CML

Eligibility Criteria

1 Year - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hematology-Oncology & SCT Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Stem cell Transplant using two unrelated umbilical cord blood units.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neutrophil and platelet engraftment

Severity of acute graft-vs-host disease(GvHD

Early transplant related mortality

Overall and disease free survival at one years

Full Information

NCT ID

NCT01015742

First Posted

November 17, 2009

Last Updated

May 31, 2012

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01015742

Brief Title

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

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

AML, ALL, CML

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Stem cell Transplant using two unrelated umbilical cord blood units.

Intervention Type

Drug

Intervention Name(s)

Stem cell Transplantation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Neutrophil and platelet engraftment

Time Frame

1 year

Title

Severity of acute graft-vs-host disease(GvHD

Time Frame

1 year

Title

Early transplant related mortality

Time Frame

100 days

Title

Overall and disease free survival at one years

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ardeshir Ghavamzadeh, MD

Phone

84902635

Ext

+98-21

ghavamza@sina.tums.ac.ir

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Ali Hamidieh, MD

Organizational Affiliation

Hematology-Oncology and SCT Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hematology-Oncology & SCT Research Center

City

Tehran

ZIP/Postal Code

14114

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amir Ali Hamidieh, MD

Phone

84902645

Ext

+98-21

aahamidieh@sina.tums.ac.ir

First Name & Middle Initial & Last Name & Degree

Ardeshir Ghavamzadeh, MD

First Name & Middle Initial & Last Name & Degree

Amir Ali Hamidieh, MD

First Name & Middle Initial & Last Name & Degree

Omid Modiramani, MD

12. IPD Sharing Statement

Learn more about this trial

Unrelated Double Umbilical Cord Blood Units Transplantation

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