NCT02210065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

March 3, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4.2 years

First QC Date

August 4, 2014

Results QC Date

February 6, 2020

Last Update Submit

March 10, 2020

Conditions

LeukemiaLymphoma

Keywords

LeukemiaLymphomaBlood And Marrow TransplantationHematological malignanciesCytotoxic T cellsCTLCytomegalovirusCMVAllogeneic hematopoietic stem cell transplantationHSCT

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Non-Relapse Mortality

    Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.

    6 months

  • Success Rate of Cytotoxic T Cells

    Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.

    28 days

Study Arms (1)

Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)

EXPERIMENTAL

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)

Interventions

Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)BIOLOGICAL

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.

Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by Site

Results Point of Contact

Title
Dr. Betul Oran / Associate Professor, Stem Cell Transplantation
Organization
U.T. MD Anderson Cancer Center
BOran@mdanderson.org
713-745-2820

Study Officials

  • Betul Oran, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 6, 2014

Study Start

March 3, 2015

Primary Completion

May 13, 2019

Study Completion

May 13, 2019

Last Updated

March 17, 2020

Results First Posted

March 17, 2020

Record last verified: 2020-03

Locations

US(1)