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Unrelated Double Umbilical Cord Blood Units Transplantation

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ClinicalTrials.gov Identifier: NCT01015742
Recruitment Status : Unknown
Verified May 2012 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 18, 2009
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013


Arms and Interventions

Arm Intervention/treatment
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.



Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Neutrophil and platelet engraftment [ Time Frame: 1 year ]
  2. Severity of acute graft-vs-host disease(GvHD [ Time Frame: 1 year ]
  3. Early transplant related mortality [ Time Frame: 100 days ]
  4. Overall and disease free survival at one years [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01015742     History of Changes
Other Study ID Numbers: HORCSCT-0902
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: May 2012

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

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