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Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders


Phase 1/Phase 2
N/A
30 Years
Not Enrolling
Both
Leukemia, Lymphoma, Neuroblastoma, Immunologic Deficiency Syndrome, Anemia

Thank you

Trial Information

Double Umbilical Cord Blood Transplantation for Patients With Malignant and Non-Malignant Disorders


Inclusion Criteria:



- Patients will be eligible for double cord blood stem cell transplant (TNC ≥ 4x107/kg
of two combined units) if available single cord blood has TNC ≤4.0 x 107/kg and they
lack a matched (5-6/6) family donor, a 10/10 unrelated adult donor, and/or if their
disease status required emergent stem cell transplant and they could not wait 2-3
months for searching for a matched unrelated adult donor.

- Adequate renal function defined as:Serum creatinine <1.5 x normal, or Creatinine
clearance or radioisotope GFR >60 ml/min/m2 or >60 ml/min/1.73 m2 or an equivalent
GFR as determined by the institutional normal range.

- 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:Shortening fraction >27% by echocardiogram, or
Ejection fraction >47% by radionucleotide angiogram or 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.

Eligibility for Moderate Intensity, Reduced Intensity Regimen and Fanconi's Anemia
(Regimens C, D and E)

- 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 >40% by radionucleotide angiogram or echocardiogram.

- Adequate pulmonary function defined as:Uncorrected 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% on room air.

Exclusion Criteria:

- Females who are pregnant or breast-feeding

- Patients with documented uncontrolled infection at the time of study entry

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant.

Outcome Time Frame:

Until end of study

Safety Issue:

Yes

Principal Investigator

Prakash Satwani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAC3457

NCT ID:

NCT00801931

Start Date:

October 2007

Completion Date:

December 2012

Related Keywords:

  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Immunologic Deficiency Syndrome
  • Anemia
  • Cord Blood Transplant
  • Allogeneic Stem Cell Transplant
  • Anemia
  • Immunologic Deficiency Syndromes
  • Leukemia
  • Lymphoma
  • Neuroblastoma

Name

Location

Columbia Presbyterian Medical CenterNew York, New York  10032