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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02210065
Recruitment Status : Active, not recruiting
First Posted : August 6, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation
Actual Study Start Date : March 3, 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
Biological: Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)
CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.




Primary Outcome Measures :
  1. Time to Non-Relapse Mortality [ Time Frame: 6 months ]
    Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy. Time to non-relapse mortality defined as time to non-relapse mortality from date of stem cell transplantation. Treatment failure event defined as death, graft failure, or grade 3-4 toxicity secondary to CTL infusion in 6 months after CTL infusion. The Bayesian method of Thall, et used to monitor non-relapse mortality.

  2. Success Rate of Cytotoxic T Cells [ Time Frame: 28 days ]
    Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
  3. Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have <5% blasts in the bone marrow.
  4. Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
  5. Patients >/= 18 years of age.
  6. Karnofsky greater than or equal to 80%.
  7. CMV seropositive.
  8. Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
  9. Hgb greater than 10 g/L.
  10. Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
  11. Negative pregnancy test in female patients of childbearing potential.
  12. 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.
  13. Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)> 0.5 X 10^3/for 3 consecutive days.
  14. Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent.
  15. Negative pregnancy test in female patients of childbearing potential.

Exclusion Criteria:

  1. STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
  2. CMV seronegative.
  3. Positive for HIV, HBV, HCV, HTLV1 and/or HTLV2.
  4. STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
  5. Patients receiving ATG, or Campath within 28 days of CMV reactivation.
  6. 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.
  7. Patients who have received donor lymphocyte infusion (DLI) within 28 days.
  8. Patients with active acute GVHD grades II-IV.
  9. Active and uncontrolled relapse of malignancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210065


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Miltenyi Biotec GmbH
Investigators
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Principal Investigator: Betul Oran, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02210065     History of Changes
Other Study ID Numbers: 2013-0620
NCI-2014-02335 ( Registry Identifier: NCI CTRP )
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lymphoma
Blood And Marrow Transplantation
Hematological malignancies
Cytotoxic T cells
CTL
Cytomegalovirus
CMV
Allogeneic hematopoietic stem cell transplantation
HSCT