Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies (UCALL)
N/A
N/A
Both
Lymphoid Hematological Malignancies, Umbilical Cord Blood Transplant
Trial Information
Umbilical Cord Blood Transplant for Children With Lymphoid Hematological Malignancies (UCALL)
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 line, the following chemotherapy will be given to after
admission to the hospital and before the infusion of the umbilical cord blood stem cells:
- 9 - 6 days before the infusion: Total Body Irradiation (TBI) in two fractions ("doses")
per days.
- 5 - 2 days before the infusion: Cytoxan given daily for 4 days, over 1 hour as an
intravenous infusion. Mesna will be given per standards. Mesna is a drug given to
decrease the side effects of Cytoxan. It will be given daily as an intravenous infusion
while the patient receives the Cytoxan.
- 4 - 2 days before the infusion: Fludarabine given daily for 3 days over 1 hour as an
intravenous infusion.
Stem cell transplant (intravenous infusion of the UCB stem cells) - defined as day 0 of the
treatment. All other "numbered" days relate to this infusion date. For example, Day 1 is the
first day after the stem cell transplant.
The following medications will be given to help decrease side effects from the chemotherapy
and UCB infusion: Cyclosporine A (CSA) will be given starting 3 days prior to the stem cell
infusion. It will be given daily over 2 hours every 12 hours, after the infusion and then
tapered if no GVHD is present.
Administration of Mycophenolate mofetil (MMF) will start on the day the stem cell infusion
is completed and will continue daily for 45 days, unless the patient develops GvHD.
Intravenous immunoglobulin's (IVIG) will be given monthly until GVHD therapy is stopped and
there is evidence that the patient's body is producing antibodies.
Study Evaluations: Various study evaluations will be performed before and during the trial.
Follow Up: After year 1, the patient will be asked to return to the clinic once a year for
consultations and bone marrow tests. A follow up bone marrow biopsy and aspirate will be
done 1 and 2 years after transplant. Consultations with specialists will be similar to the
ones the patient had before the transplant.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival at 1 year after UCB transplant in pediatric patients
Outcome Description:
To determine the survival rate at 1 year after umbilical cord blood transplant in pediatric patients with lymphoid hematological malignancies
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Caridad A Martinez, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
26336-UCALL
NCT ID:
NCT01247688
Start Date:
November 2010
Completion Date:
November 2020
Related Keywords:
- Lymphoid Hematological Malignancies
- Umbilical Cord Blood Transplant
- Lymphoid
- hematologic malignancy
- UCB
- Umbilical Cord Blood Transplant
- Total Body Irradiation
- Cytoxan
- Cyclophosphamide
- Fludarabine
- Neoplasms
- Hematologic Neoplasms
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
