Unrelated Double Umbilical Cord Blood Units Transplantation

NCT ID: NCT01015742

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-01-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Stem cell Transplant using two unrelated umbilical cord blood units.

Group Type: EXPERIMENTAL

Stem cell Transplantation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir Ali Hamidieh, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology-Oncology and SCT Research Center

Locations

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Ardeshir Ghavamzadeh, MD

Role: CONTACT

ghavamza@sina.tums.ac.ir

84902635 ext. +98-21

Facility Contacts

Amir Ali Hamidieh, MD

Role: primary

aahamidieh@sina.tums.ac.ir

84902645 ext. +98-21

Other Identifiers

HORCSCT-0902

Identifier Type: -

Identifier Source: org_study_id