NCT01015742

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 4, 2012

Status Verified

May 1, 2012

Enrollment Period

3.1 years

First QC Date

November 17, 2009

Last Update Submit

May 31, 2012

Conditions

Leukemia, Myeloid, AcuteLeukemia, Lymphoblastic, AcuteLeukemia, Myeloid, Chronic

Keywords

AMLALLCML

Outcome Measures

Primary Outcomes (1)

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

    Until end of study

Secondary Outcomes (4)

  • Neutrophil and platelet engraftment

    1 year

  • Severity of acute graft-vs-host disease(GvHD

    1 year

  • Early transplant related mortality

    100 days

  • Overall and disease free survival at one years

    1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Stem cell Transplant using two unrelated umbilical cord blood units.

Drug: Stem cell Transplantation

Interventions

Stem cell TransplantationDRUG

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.

Experimental

Eligibility Criteria

Age1 Year - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Amir Ali Hamidieh, MD

    Hematology-Oncology and SCT Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardeshir Ghavamzadeh, MD

CONTACT

84902635ghavamza@sina.tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

June 4, 2012

Record last verified: 2012-05

Locations

IR(1)