Status:
ACTIVE_NOT_RECRUITING
CASPALLO: Allodepleted T Cells Transduced With Inducible 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
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE1
Brief Summary
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very...
Detailed Description
Because the patient will receive cells with a new gene in them, they will be followed for a total of 15 years to see if there are any long-term side effects of the gene transfer. Before the condition...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- At the time of transplant:
- A. Patients (up to 65 years of age) with:
- ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease.
- Myelodysplastic syndrome.
- AML after first relapse or with primary refractory disease.
- CML
- Hemophagocytic lymphohistiocytosis (HLH); familial hemophagocytic lymphohistiocytosis (FLH); viral-associated hemophagocytic syndrome (VAHS); patients with severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T or NK cell malignancy; X-linked lymphoproliferative disease (XLP)
- B. Lack of 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.
- At the time of allodepleted T cell infusion:
- Engrafted with ANC greater than 500.
- Must have greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
- Life expectancy greater than 30 days
- Lansky/Karnofsky scores greater than or equal to 60
- Absence of severe renal disease (creatinine greater than 2X normal for age)
- Absence of severe hepatic disease (direct bilirubin greater than 2 mg/dL, or SGOT greater than 200
- Oxygen saturation greater than 94% on room air
- Patient/Guardian able to give informed consent
- EXCLUSION CRITERIA:
- At the time of transplant:
- 1\. Pregnancy\*
- At the time of allodepleted 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.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00710892
Start Date
December 1 2008
End Date
July 1 2026
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