Status:
COMPLETED
Umbilical Cord Blood Transplant for Hematological Malignancies
Lead Sponsor:
University of Pennsylvania
Conditions:
CML
AML
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant. In this study, subjects will undergo...
Detailed Description
The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen. Activated T cell...
Eligibility Criteria
Inclusion
- Inclusion Criteria.
- Relapsed or persistent advanced hematologic malignancy; incurable with standard chemotherapy and eligible for allogeneic HSCT, including:
- CHRONIC MYELOGENOUS LEUKEMIA (CML). Subjects in accelerated or blast phase or subjects in chronic phase with inadequate response to Imatinib or intolerant to Imatinib.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subject with high risk disease in first complete remission (CR). High risk disease includes the following cytogenetic abnormalities: monosomy 7, deletion 5, trisomy 8, inversion 3, t(3;3), t(6;9), or t(6;11). Subjects with complex cytogenetic abnormalities (more than 3 chromosomal abnormalities).
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with diagnosis of AML after receiving chemotherapy, radiation therapy or biopsy showing myelodysplastic syndrome.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with persistent AML after 2 cycles of standard induction chemotherapy.
- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects in first complete remission.
- MYELODYSPLASTIC SYNDROME (MDS). Subjects with intermediate or high risk disease based upon International Prognostic Scoring System.
- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with Philadelphia Chromosome (have t(9;22) cytogenetic abnormality) or molecular documentation for BCR-ABL translocation.
- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with primary refractory disease or subjects in 1st complete remission.
- NHL or HODKIN'S DISEASE. Subjects who relapse following autologous Stem Cell Transplant.
- INDOLENT NHL. Subjects with progressive disease following \> 2 regimens.
- MULTIPLE MYELOMA. Subjects who relapse following following autologous Stem Cell Transplant.
- Adults age 21-50.
- Expected survival 4 weeks.
- Subjects with no suitable related or unrelated donor for Stem Cell Transplant.
- Subject has suitable Umbilical Cord Blood (UCB) unit available.
- Subject has: Ejection fraction \> 45%; DLCO.45% predicted; Creatinine \< 2; Total bilirubin \< 2X normal; Transaminases \< 2X normal.
- Subject is capable of giving informed consent.
- Exclusion Criteria:
- Subject is pregnant or lactating.
- Subject has an uncontrolled infection.
- Subject has an active or untreated disease involving the central nervous system.
- Subject has an active or uncontrolled medical condition that would preclude participation in the protocol.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00891592
Start Date
January 1 2009
End Date
May 1 2016
Last Update
August 19 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104