Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation

Completed · Phase 2

Conditions studied: Leukemia, Lymphoma

In brief

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 cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.

Key facts

Study ID

NCT02210065

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2015-03-03

Expected to finish

2019-05-13

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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