Cytokine-Treated Veto Cells in Treating Participants With Hematologic Malignancies Following Stem Cell Transplant

Overview

This phase I/II trial studies how well cytokine-treated veto cells work in treating participants with hematologic malignancies following stem cell transplant. Giving chemotherapy and total-body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. cytokine-treated veto cells may help the transplanted donor cells to develop and grow in recipients without causing graft-versus-host-disease (GVHD - when transplanted donor tissue attacks the tissues of the recipient's body).

SparkCures ID 1021
Trial Phase Phase 1/2
Enrollment 48 Patients
Treatments
Trial Sponsors
  • MD Anderson Cancer Center
Trial Collaborators
  • National Cancer Institute (NCI)
NCT Identifier

NCT03622788

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Patients with a diagnosis either follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), Hodgkin's lymphoma (HL), non-Hodgkin's lymphoma (NHL), chronic myeloid leukemia (CML), myelodysplastic syndrome, myeloproliferative syndromes (MPD), acute myeloid leukemia (AML) or acute lymphoid leukemia (ALL).
  • Patients with aplastic anemia and severe immune deficiency or nonmalignant bone marrow failure states.
  • Patients with hematological malignancies must have had persistent or progressive disease despite initial chemotherapy and must have achieved stable disease or a partial or complete response to their most recent chemotherapy. Patients with low bulk or indolent relapse are eligible without additional treatment. Patients with high risk acute myeloid leukemia by European LeukemiaNet (ELN) criteria in first remission are eligible.
  • Availability of a haploidentical related donor.
  • Karnofsky performance status >= 70%.
  • Left ventricular ejection fraction of at least 40%.
  • Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration.
  • Serum creatinine =< 1.5 mg/dl.
  • Serum glutamic-pyruvic transaminase (SGPT) =< 200 IU/ml.
  • Bilirubin < 1.5 mg/dl (unless Gilbert's syndrome).
  • Negative pregnancy test in a woman with child bearing potential.

Exclusion Criteria:

  • Human immune deficiency virus (HIV) seropositive.
  • Uncontrolled infection or serious medical or psychiatric condition that would limit tolerance to the protocol treatment.
  • Active central nervous system (CNS) malignancy.
  • Availability of medically eligible, human leukocyte antigen (HLA)-matched related stem cell donor

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Texas

Resources

There are no resources, links or videos to display for this clinical trial.