Trial | NCT00890500  Report issue

Title

Safety and Efficacy of ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematologic Malignancies.
A Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematological Malignancies.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.

-As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.
Study Started
Jan 31
2011
Primary Completion
May 31
2013
Study Completion
Oct 31
2013
Last Update
Oct 08
2013
Estimate

Drug Fludarabine

30mg/m2/day IV x 6 days

Drug Melphalan

100 mg/m2/day IV x 1 day

Drug Antithymocyte Globulin

1mg/kg/day x 4 days

Drug Sirolimus

GVHD Prophylaxis: Target range 3-12 ng/ml

Drug Tacrolimus

GVHD Prophylaxis: Target range 5-10 ng/ml

Group 1 Active Comparator

2 umbilical cord units: Second cord blood unit modulated with ProHema

Group 2 Active Comparator

2 umbilical cord units: First cord blood unit modulated with ProHema

Criteria 

Inclusion Criteria:

Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate
Patient must be ineligible for traditional myeloablative transplantation according to treating physician
Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant
18-65 years of age
ECOG Performance Status 0-2

Exclusion Criteria:

The following hematologic malignancies are excluded:

Myelofibrosis unless there has been exposure to cytotoxic chemotherapy for the treatment of progression to acute myeloid leukemia
Chronic Myelogenous Leukemia, unless there has been exposure to cytotoxic chemotherapy for the treatment of blast phase, 3) Aplastic anemia, in the absence of transformation to Myelodysplastic disorder
Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension
Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected hemoglobin
Renal disease: serum creatinine > 2.0mg/dl
Hepatic disease: serum bilirubin > 2.0mg/dl (expect in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 3 x upper limit of normal
Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
HIV antibody
Uncontrolled infection
Pregnancy or breast feeding mother
Inability to comply with the requirements for care after allogeneic stem cell transplantation
No Results Posted