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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01050439
Other study ID # AAAB3095
Secondary ID CHNY-02-516
Status Terminated
Phase Phase 2
First received June 3, 2008
Last updated April 14, 2015
Start date November 2002
Est. completion date April 2011

Study information

Verified date April 2015
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Unrelated matched donor (cord blood, bone marrow or peripheral blood) allogeneic stem cell transplantation (UDAlloSCT) with either myeloablative or reduced intensity conditioning will be well tolerated and result in a high degree of engraftment in patients with selected malignant and non malignant disorders.


Description:

This is a non-randomized study to determine the tolerability and degree of engraftment of unrelated matched donor allogeneic stem cell transplantation with either myeloablative or reduced intensity conditioning in patients with selected malignant and non malignant disorders. Patients will receive one of either full intensity or reduced intensity regimen based on the patient's disease status, organ function and performance and determined by the PI.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 55 Years
Eligibility Inclusion Criteria:

- Adequate renal function defined as: serum creatinine 2.0 x normal, or creatinine clearance or radioisotope GFR > 40 ml/min/m2 or > 40 ml/min/1.73 m2 or an equivalent GFR as determined by the institutional normal range.

- Adequate liver function defined as: total bilirubin < 2.5 x normal; or SGOT (AST) or SGPT (ALT) < 5.0 x normal.

- Adequate cardiac function defined as: shortening fraction of > 25% by echocardiogram, or ejection fraction of > 40% by radionuclide angiogram or echocardiogram.

- Adequate pulmonary function defined as: DLCO > 35% by pulmonary function test. For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% in room air.

- Diseases:

- CML (CP, AP or BC)

- AML/MDS/JCML

- ALL

- Lymphoma (Hodgkin's and non-Hodgkin's)

- Non-malignant disorders

- Bone Marrow Failure Syndromes: Patients with the following diagnoses are eligible:

- Severe Aplastic Anemia:

- Fanconi Anemia

- Severe Congenital Neutropenia (Kostmann's Syndrome)

- Amegakaryocytic Thrombocytopenia

- Diamond-Blackfan Anemia

- Infantile Osteopetrosis

- Schwachman-Diamond Syndrome

- Dyskeratosis Congenita

- Other bone marrow failure syndromes at discretion of Principal Investigator

- Immunodeficiencies:

- SCIDS, all subtypes

- Combined Immunodeficiency Syndrome

- Wiskott-Aldrich syndrome

- Chronic Granulomatous Disease

- Chediak-Higashi Syndrome

- Leukocyte Adhesion Deficiency

- Other immunodeficiencies at discretion of Principal Investigator

- Inborn Errors of Metabolism (IEOM):

- Transplant is recommended for the following disorders: Hurler syndrome (L-iduronidase deficiency, MPS-I), Maroteaux-Lamy syndrome (galactosamine-4-sulfatase deficiency, MP VI), Sly syndrome (glucuronidase deficiency, MPS-VII), Globoid cell Leukodystrophy (galactocerebrosidasedeficiency), Metachromatic leukodystrophy (arylsulfatase A deficiency), Childhood-onset X-linked adrenoleukodystrophy (X-ALD), Fucosidosis (fucosidase deficiency), Mannosidosis, Aspartylglucosaminuria, Niemann-Pick Disease Type B (acid sphingomyelinase deficiency), Gaucher disease (glucocerebrosidase deficiency) Type I (non neuropathic), Other diagnoses may be considered at the discretion of the Principal Investigator

- For X-ALD patients greater than 5 years of age, IQ > 80 is required. For other patients greater than 5 years of age, IQ > 70 is required.

- For patients less than 5 years of age, the developmental quotient or clinical neurodevelopmental examination should demonstrate potential for stabilization at a level of functioning where continuous life support (e.g. mechanical ventilation) would not be predicted to be required in the year following transplantation.

- Histiocytosis:

- Hemophagocytic Lymphohistiocytosis (HLH)

- Familial Erythrophagocytic Lymphohistiocytosis

- Langerhans Cell Histiocytosis

- Malignant Histiocytosis

- Other Malignant and non-malignant diseases: Other malignant and non-malignant diseases not listed above may be eligible if deemed appropriate by the Principal Investigator.

Exclusion Criteria:

- Women who are pregnant and/or breast feeding are ineligible

Study Design

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


Intervention

Procedure:
UDAlloSCT
unrelated matched donor allogeneic stem cell transplantation (UDAlloSCT)
Other:
Therapy
Full Intensity Therapy (myeloablative) (TBI + Thiotepa + Cyc) OR Reduced Intensity Therapy (Fludarabine, Busulfan, and Alemutuzumab (FBA))

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of toxicity related to myeloablative therapy To determine the safety and toxicity of myeloablative therapy (TBI + Melphalan) and unrelated donor alloSCT in selected patients with malignant and non-malignant disorders. Up to 10 years from start of study Yes
Secondary Incidence of toxicity related to reduced intensity therapy To determine the safety and toxicity of reduced intensity therapy (Fludarabine, Busulfan, and Alemtuzumab (FBA) and unrelated donor alloSCT in selected patients with malignant and non malignant disorders Up to 10 years from start of study Yes
Secondary Percentage of donor chimerism To quantitate the percentage of donor chimerism following both myeloablative and reduced intensity conditioning and unrelated donor alloSCT in selected patients with malignant and non-malignant disorders. Up to 10 years from start of study No
Secondary Prevalence of progression free survival To estimate the progression free survival (PFS), if applicable, event free survival (EFS) and overall survival (OS) following unrelated donor alloSCT in selected patients with malignant and non malignant disorders. Up to 10 years from start of study No
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