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

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    24
  • sponsor
    M.D. Anderson Cancer Center
Updated on 30 January 2021
cancer
remission
chronic myeloid leukemia
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
anemia
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
multiple myeloma
hodgkin's disease
white blood cell count
ejection fraction
cytokines
cell transplantation
leukemia
bone marrow procedure
lymphocytic leukemia
gilbert's syndrome
antithymocyte globulin
myeloproliferative syndromes
white blood cells
progressive disease
chemotherapy regimen
follicular lymphoma
mantle cell lymphoma
aplastic anemia
blood cell count
lymphocyte immune globulin

Summary

This phase I/II trial studies how well cytokine-treated veto cells work in treating patients 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 patient, they may help the patient'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).

Description

PRIMARY OBJECTIVE:

I. To determine the optimal dose of anti-viral veto cells, defined as the dose which achieves engraftment without severe graft-vs-host disease (GVHD) at 42 days after non-myeloablative megadose T cell depleted haploidentical hematopoietic cell transplantation (HCT).

SECONDARY OBJECTIVES:

I. Toxicity. II. Response rate. III. Time to progression. IV. Infections. V. Immune reconstitution. VI. Overall survival up to 1 year.

OUTLINE: This is a dose-escalation study of cytokine-treated veto cells.

CONDITIONING REGIMEN: Patients receive anti-thymocyte globulin (ATG) intravenously (IV) over 4 hours on days -9 to -7 and fludarabine IV over 1 hour on days -6 to -3, then undergo total body irradiation (TBI) on day -1.

TRANSPLANT: Patients undergo peripheral blood stem cell transplantation (PBSCT) IV over 30-60 minutes on day 0.

GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days +3 and +4 and cytokine-treated veto cells IV over 30-60 minutes on day +7.

After completion of stem cell transplant, patients are followed up once a week for 4 weeks, once a month for 3 months, and then periodically for one year.

Details
Condition Bone marrow disorder, childhood ALL, Pancytopenia, Follicular Lymphoma, Hodgkin's Disease, organ donor, Multiple Myeloma, Lymphoma, Preleukemia, Anemia, Aplastic Anemia, Acute myeloid leukemia, Mantle cell lymphoma, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Acute Myeloid Leukemia in Remission, Hematopoietic Cell Transplantation Recipient, Myeloproliferative Neoplasms, Partial Response of Multiple Myeloma or Plasma Cell Leukemia, Anemia; Non-Small-Cell Lung Cancer, Lymphocytic Leukemia, Acute, Anemia; Non-Hodgkin’s Lymphoma, Lymphoproliferative disorders, Hematopoietic Cell Transplant Recipient, Near Complete Response of Multiple Myeloma or Plasma Cell Leukemia, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, non-hodgkin's lymphoma (nhl), bone marrow failure, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment anti-thymocyte globulin, cyclophosphamide, peripheral blood stem cell transplantation, Fludarabine, Total-Body Irradiation, Cytokine-treated Veto Cells
Clinical Study IdentifierNCT03622788
SponsorM.D. Anderson Cancer Center
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

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
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