Status:
COMPLETED
Umbilical Cord Blood Transplant for Children With Myeloid Hematological Malignancies
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Myeloid Hematological Malignancies
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
In this study, the investigators will use busulfan and cyclophosphamide (BuCy) backbone with the addition of fludarabine as the preparative Stem Cell Transplant (SCT) regimen. As an attempt to improve...
Detailed Description
The following will be given as the conditioning regimen for the transplant: BUSULFAN: Busulfan (intravenous BUSULFEX) dosing will be as follows: patients \<12 kg: 1.1 mg/kg/dose IV every 6 hours for ...
Eligibility Criteria
Inclusion
- Patients with a myeloid hematologic malignancy (acute myelogenous leukemia, secondary myelogenous leukemia or myelodysplastic syndrome) unlikely to be cure by standard chemotherapy. This includes patients who have relapsed after standard chemotherapy treatments and patients in first remission with unfavorable prognostics features.
- Related or Unrelated Umbilical Cord Blood Unit with 0-1 antigen mismatch at HLA-A and B (at low resolution) and DRB1 (at high resolution), with a total nucleated cell dose of ≥ 4 x 10\^7/kg.
- Lansky/Karnofsky scores at least 60.
- Written informed consent and/or signed assent line from patient, parent or guardian.
- Negative pregnancy test, if applicable.
Exclusion
- Patients with uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections, patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Severe renal disease (Creatinine \> 3X normal for age).
- Severe hepatic disease (direct bilirubin \> 3 mg/dL or SGOT \> 500).
- Patient has DLCO \< 50% predicted or FEV1 \< 50% of predicted, if applicable.
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction \< 20%).
- HIV positive.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01247701
Start Date
November 1 2010
End Date
October 1 2019
Last Update
June 8 2022
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030