Status:
WITHDRAWN
Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Lymphoid Hematological Malignancies
Umbilical Cord Blood Transplant
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety and effectiveness of UCBT to treat patients with lymphoid hematological diseases and to see if this treatment can decrease the incidence of leukemi...
Detailed Description
After the eligible criterion for treatment has been met and a suitable UCB stem donor has been found, the patient will have a central line placed. Research Therapy: After placement of the central li...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Potential recipients of umbilical cord blood transplantation (i.e. HLA (human leukocyte antigen) matched or mismatched / related or unrelated) with a lymphoid hematologic malignancy (acute lymphoblastic leukemia, hodgkin/non-hodgkin lymphoma) 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, Total Nucleated cell dose of greater than or equal to 4 x 10\^7/kg.
- Lansky/Karnofsky scores greater than or equal to 60
- Negative pregnancy test (if applicable)
- Written informed consent and/or signed assent line from patient, parent or guardian.
- EXCLUSION CRITERIA:
- 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 \> x 3 normal for age)
- Severe hepatic disease (direct bilirubin \> 3 mg/dl or SGOT (Serum glutamic oxaloacetic transaminase) \> 500)
- Patient has DLCO (Diffusing Capacity of the Lung for Carbon Monoxide) \< 50% predicted or FEV1 (Forced expiratory volume ) \< 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
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01247688
Start Date
November 1 2010
End Date
December 1 2013
Last Update
December 12 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.