Study on Cytokine-Treated Veto Cells for Patients with Blood Cancers After Stem Cell Transplant

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03622788

Provider View

This clinical trial is exploring the use of cytokine-treated veto cells to help treat patients with blood cancers after they receive a stem cell transplant. The study aims to see if these cells can help the new donor cells grow without causing harmful side effects.

Patient Parameters

Program Overview

This study is testing a new approach using cytokine-treated veto cells to help patients with blood cancers who have undergone a stem cell transplant. Before the transplant, patients receive chemotherapy and total-body irradiation to prepare their bodies. The healthy stem cells from a donor are then infused to help the patient's bone marrow produce new blood cells. The cytokine-treated veto cells are intended to support the growth of these donor cells while preventing a condition called graft-versus-host disease (GVHD), where the donor cells attack the patient's body.

Description

The main goal of this study is to find the best dose of veto cells that can help the donor cells grow without causing severe graft-versus-host disease (GVHD) within 42 days after a specific type of stem cell transplant. The study also looks at side effects, how well the treatment works, how long it takes for the disease to progress, infections, immune system recovery, and overall survival for up to one year.

The study involves several steps:

  • Conditioning Regimen: Patients receive medications and total body irradiation to prepare for the transplant.
  • Transplant: Patients receive a stem cell transplant from a donor.
  • GVHD Prevention: Patients receive additional medications and cytokine-treated veto cells to help prevent GVHD.

After the transplant, patients are monitored weekly for four weeks, monthly for three months, and then periodically for a year to check their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Age 12-75 years. Initial participants will be adults to ensure safety, then adolescents may join if safe.
  • Diagnosed with certain blood cancers or conditions like follicular lymphoma, chronic lymphocytic leukemia, multiple myeloma, and others.
  • Conditions like aplastic anemia, severe immune deficiency, or sickle cell disease with severe symptoms.
  • Patients must have had persistent or progressive disease despite initial treatment and show stable or improved disease after recent treatment.
  • Must have a suitable donor who is a partial match and aged 12-70 years.
  • Good overall health with a performance status of 70% or higher.
  • Adequate heart and lung function, and normal kidney and liver tests.
  • Negative pregnancy test for women of childbearing potential.

Exclusion Criteria

  • HIV positive.
  • Uncontrolled infection or serious medical or psychiatric condition.
  • Active cancer in the central nervous system.
  • Availability of a fully matched related stem cell donor.

Donor Inclusion Criteria

  • Suitable donor aged 12-70 years.
  • Healthy blood counts and no blood disorders.
  • Negative pregnancy test for women of childbearing potential.
  • Normal blood pressure and heart health.
  • No allergies to cytokines if used.
  • No active autoimmune disorders.
  • Completion of a health questionnaire and assessment.

Donor Exclusion Criteria

  • Cognitive impairments or serious unstable conditions.
  • Unable to provide informed consent or comply with study procedures.

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