CASPALLO: Allodepleted T Cells Transduced With Inducible Caspase 9 Suicide Gene

Plain-language summary

This study examines transferring an inducible caspase 9 "suicide gene" into donor T cells in patients undergoing stem cell transplant. The gene allows the cells to be selectively eliminated with a drug if they cause graft-versus-host disease. Patients up to 65 years old transplanted for leukaemia, lymphoma or myelodysplastic syndrome took part. It is a Phase 1 study, active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Baylor College of Medicine

Intervention

Allodepleted T Cells

Start date

12/1/2008

Estimated completion

7/1/2027

Countries

United States

Related genes

Locations

• Houston, United States
• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

INCLUSION CRITERIA:

At the time of transplant:

A. Patients (up to 65 years of age) with:

1. ALL or high grade NHL that is Stage III or IV and has relapsed or is considered to be primary refractory disease.
2. Myelodysplastic syndrome.
3. AML after first relapse or with primary refractory disease.
4. CML
5. 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:

1. Engrafted with ANC greater than 500.
2. Must have greater than or equal to 50% donor chimerism in either peripheral blood or bone marrow, or relapse of their original disease.
3. Life expectancy greater than 30 days
4. Lansky/Karnofsky scores greater than or equal to 60
5. Absence of severe renal disease (creatinine greater than 2X normal for age)
6. Absence of severe hepatic disease (direct bilirubin greater than 2 mg/dL, or SGOT greater than 200
7. Oxygen saturation greater than 94% on room air
8. Patient/Guardian able to give informed consent

EXCLUSION CRITERIA:

At the time of transplant:

1\. Pregnancy\*

At the time of allodepleted T cell infusion:

1. GvHD
2. Severe intercurrent infection
3. Pregnancy\*
4. 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.