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Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies


Phase 2/Phase 3
1 Year
50 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid, Chronic

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Trial Information

Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Until end of study

Safety Issue:

No

Principal Investigator

Amir Ali Hamidieh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hematology-Oncology and SCT Research Center

Authority:

Iran: Ministry of Health

Study ID:

HORCSCT-0902

NCT ID:

NCT01015742

Start Date:

November 2009

Completion Date:

January 2013

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Myeloid, Chronic
  • AML
  • ALL
  • CML
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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