Unrelated Double Umbilical Cord Blood Units Transplantation
This study is currently recruiting participants.
Verified May 2012 by Tehran University of Medical Sciences
Sponsor:
Tehran University of Medical Sciences
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
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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
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 Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid 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 |
ClinicalTrials.gov processed this record on May 23, 2013