Status:
COMPLETED
Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Miltenyi Biotec B.V. & Co. KG
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem...
Detailed Description
The CTLs: Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your transplan...
Eligibility Criteria
Inclusion
- STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
- Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
- Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have \<5% blasts in the bone marrow.
- Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
- Patients \>/= 18 years of age.
- Karnofsky greater than or equal to 80%.
- CMV seropositive.
- Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
- Hgb greater than 10 g/L.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
- Negative pregnancy test in female patients of childbearing potential.
- STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): CMV reactivation defined as CMV DNAemia \>/= 137 copies/ml.
- Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)\> 0.5 X 10\^3/for 3 consecutive days.
- Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent.
- Negative pregnancy test in female patients of childbearing potential.
Exclusion
- STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
- CMV seronegative.
- Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.
- STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
- Patients receiving ATG, or Campath within 28 days of CMV reactivation.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days.
- Patients with active acute GVHD grades II-IV.
- Active and uncontrolled relapse of malignancy.
Key Trial Info
Start Date :
March 3 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02210065
Start Date
March 3 2015
End Date
May 13 2019
Last Update
March 17 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030