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

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Brief Title

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

Official Title

Anti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell Transplantation

Brief 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).
    

Detailed 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Optimal dose of donor-derived cytokine-treated veto cells

Secondary Outcome

 Incidence of adverse events

Condition

Acute Lymphoblastic Leukemia

Intervention

Anti-Thymocyte Globulin

Study Arms / Comparison Groups

 Treatment (chemotherapy, PBSCT, cytokine-treated veto cells)
Description:  CONDITIONING REGIMEN: Patients receive ATG IV over 4 hours on days -9 to -7, and fludarabine IV over 1 hour on days -6 to -3, then undergo TBI on day -1.
TRANSPLANT: Patients undergo 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

24

Start Date

August 8, 2019

Completion Date

July 1, 2021

Primary Completion Date

July 1, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

12 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Richard E Champlin, 713-792-8750, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03622788

Organization ID

2018-0221

Secondary IDs

NCI-2018-01557

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Richard E Champlin, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

January 2021