Status:
ACTIVE_NOT_RECRUITING
Administration of Donor T Cells With the Caspase-9 Suicide Gene
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, patients will be given very strong doses of chemotherapy, which will kill all the...
Detailed Description
If the patient is doing well after the stem cell transplant, and does not have severe GvHD, s/he will be eligible to receive the special "iCasp9" T cells from Day 30 to 90 after transplant. The specia...
Eligibility Criteria
Inclusion
- Inclusion Criteria at Time of Procurement:
- Lack of a suitable conventional donor (i.e. 5/6 or 6/6 related, or 5/6 or 6/6 unrelated donor), or presence of a rapidly progressive disease not permitting time to identify an unrelated donor.
- High risk disease in one of the following:
- Myelodysplastic syndrome (MDS) in one of the following categories: RCMD with an IPSS-R of intermediate, poor, or very poor, RAEB-1, or RAEB-2
- Acute myeloid leukemia (AML) after first relapse or primary refractory disease
- Chronic myelogenous leukemia (CML) in Chronic Phase 2 or greater, Accelerated Phase or Blast Crisis
- Acute lymphoblastic leukemia (ALL) after first relapse or primary refractory disease, or High-Grade Non Hodgkin lymphoma (NHL) Stage III or IV after first relapse or primary refractory disease
- Hemophagocytic lymphohistiocytosis (HLH)
- Familial hemophagocytic lymphohistiocytosis (FLH)
- Viral-associated hemophagocytic syndrome (VAHS)
- T or NK cell lymphoproliferative syndrome
- X-linked lymphoproliferative disease (XLP)
- Inclusion Criteria at Time of T Cell Infusion:
- Engrafted with an absolute neutrophil count (ANC) \> 500 cells/µL
- Greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease
- Life expectancy \> 30 days
- Lansky/Karnofsky score greater than or equal to 60
- Absence of severe renal disease (creatinine \> 2X upper limit of normal for age)
- Absence of severe hepatic disease (direct bilirubin \> 3X upper limit of normal or SGOT \> 3X upper limit of normal)
- Oxygen saturation \> 94% on room air
- Patient/Guardian able to give informed consent
- AP1903 available in sufficient quantities to allow for treatment of the patient
Exclusion
- Exclusion Criteria at Time of T Cell Infusion:
- GvHD
- Severe intercurrent infection
- Pregnancy\*
- Other investigational drugs in the prior 30 days
- Pregnancy test only required for at-risk individuals, defined as female patients of childbearing potential who have received a reduced-intensity conditioning regimen.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2029
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01494103
Start Date
November 1 2011
End Date
May 1 2029
Last Update
July 11 2025
Active Locations (2)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030
2
The Methodist Hospital
Houston, Texas, United States, 77030