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Unrelated Double Umbilical Cord Blood Units Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Leukemia, Myeloid, Chronic
Drug: Stem cell Transplantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: November 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Stem cell Transplant using two unrelated umbilical cord blood units.
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.


  Eligibility

Ages Eligible for Study:   1 Year to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015742

Contacts
Contact: Ardeshir Ghavamzadeh, MD 84902635 ext +98-21 ghavamza@sina.tums.ac.ir

Locations
Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Amir Ali Hamidieh, MD    84902645 ext +98-21    aahamidieh@sina.tums.ac.ir   
Sub-Investigator: Ardeshir Ghavamzadeh, MD         
Principal Investigator: Amir Ali Hamidieh, MD         
Sub-Investigator: Omid Modiramani, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Amir Ali Hamidieh, MD Hematology-Oncology and SCT Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01015742     History of Changes
Other Study ID Numbers: HORCSCT-0902
Study First Received: November 17, 2009
Last Updated: May 31, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
AML
ALL
CML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014