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LeukemiaPhase 2/3NCT02942173

CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT

A Phase 2/3 study testing CD45RA-depleted peripheral blood mononuclear cells in people with Leukemia and Lymphoma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT). Read more about this study

Who is it for?
Ages Up to 25 years
Conditions the study is for
Leukemia, Lymphoma, Myelodysplastic Syndromes
What is being tested?
CD45RA-depleted peripheral blood mononuclear cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteRussia
Study dates
Oct 2016to 21 Aug 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients who are considered candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
  • Acute lymphocytic leukemia (ALL)
  • Acute myeloid leukemia
  • Acute biphenotypic leukemia
  • Acute bilinear leukemia
  • Lymphoma
Show all 12Show fewer
  • Myelodysplastic syndrome
  • Chronic myeloid leukemia
  • Transplant processing: TCR ab/CD19-depletion
  • Donors:
  • HLA-match unrelated volunteers
  • Partly and haploidentical relative

Who cannot join

  • ALL patients not in remission
  • Patients with uncontrolled infections
  • Clearance of creatinine < 70 ml/min
  • Cardiac ejection fraction < 40%
  • Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of < 50% predicted; patients who are unable to perform pulmonary function tests will be excluded if the oxygen (O2) saturation is < 92% on room air
  • Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) >= twice the upper limit of normal
  • Mental disease of both patient, patient's tutor (if patient is under age 18) and donor, that hinder understanding of main point of the study and keeping treatment plan, hygiene and sanitation

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Federal Research Center for pediatric hematology, oncology and immunology

    Moscow, 117997

Other trials in Russia

About this study

Official title: A Phase II Prospective Randomized Trial of Donor T-memory Cells (CD45RA Depleted) Infusion for Prevention of Infections After Allogeneic TcRαβ/CD19-depleted Hematopoietic Stem Cell Transplantation

The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).

Read the detailed description

Graft-versus-host disease (GVHD) remains the most important direct complication of hematopoietic stem cell transplantation. Methods used to prevent GVHD include diverse pharmacologic interventions and ex vivo methods of T-cell depletion, the latter being the most effective ones. Historically depletion of T-cells from the graft is associated with increased rate of graft failure, relapse of malignant disease and prolonged immune deficiency. Selective depletion of TCR-alpha/beta T-lymphocytes is a new method of hematopoietic stem cell graft manipulation, which is thought to conserve important cell populations, e.g. NK cells and gamma/delta T cells within the graft. Preliminary results suggest that TCR alpha/beta depletion ensures high engraftment rate, low early mortality and good control of GVHD. The problem of delayed immune reconstitution and life-threatening viral infections remains incompletely resolved.

Depletion of naive (CD45RA-positive) T-cells was developed as a new method of graft manipulation to prevent GVHD. Research data indicate that alloreactivity is associated mainly with naive T-cell fraction. In vitro depletion of CD45RA lowers significantly the alloreactive response while retaining reactivity to pathogens.

In previous pilot protocol the investigators confirmed that infusion after TCR-alpha/beta depleted transplantation of low doses of CD45RA-depleted mononuclear cells are safe and potentially protective against viral infections. The biologic readout for the protocol was a quantitative assessment of T-cell reactivity to common pathogens after infusion and owing to the trial results expansion of CMV-specific CD8 T-cells was discovered in most of the patients.

In current randomized protocol the investigators are posing a question if donor lymphocytes infusion (DLI) of low doses of CD45RA-depleted mononuclear cells are effective in viral prophylaxis after TCR-alpha/beta depleted transplantation.

Being tested
CD45RA-depleted peripheral blood mononuclear cells
Keywords
CD45RA-depletion, TCR-alpha/beta depletion, Hematopoietic Stem Cell Transplantation
Medical subject headings
Leukemia, Lymphoma, Myelodysplastic Syndromes, Opportunistic Infections, Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD45RA-depleted peripheral blood mononuclear cellsBiological

    Infusion of escalating doses of CD45RA-depleted donor-derived allogeneic peripheral blood mononuclear cells

Study groups in NCT02942173
Study groupRoleWhat they receive
CD45RA-No interventionNot described
CD45RA+ExperimentalNot described
Receives: Biological: CD45RA-depleted peripheral blood mononuclear cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cumulative incidence of the probability of CMV-reactivation after HSCT

    Measured: 120 days after HSCT

  2. cumulative incidence of acute GVHD grade II-IV.

    Measured: 150 days after HSCT

Secondary outcomes (7)

  1. cumulative incidence of of CMV-disease at 100,180 and 365 days after HSCT

    Measured: 100, 180 and 365 days after HSCT

  2. overall survival at 365 days after HSCT

    Measured: 365 days after HSCT

  3. Event-free survival at 365 days after HSCT

    Measured: 365 days after HSCT

  4. cumulative incidence of relapse at 6 months and 365 days after HSCT

    Measured: 6 months and 365 days

  5. cumulative incidence of transplant-related mortality at 6 months after HSCT

    Measured: 6 months

  6. cumulative incidence of chronic GvHD

    Measured: 1 year after HSCT

  7. cumulative incidence of neutrophil and platelets engraftment at 14 and 30 days after HSCT

    Measured: 14 and 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion21 Aug 2019
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942173
Sponsor's protocol ID
CD45RAndom_2016_1
Status last verified
Mar 2023
First submitted
11 Oct 2016
Last updated
16 Mar 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CD45RA-depleted peripheral blood mononuclear cells in people with Leukemia and Lymphoma, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative incidence of the probability of CMV-reactivation after HSCT (time frame: 120 days after HSCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02942173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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