Personalized NK Cell Therapy in CBT

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02727803
Phase
PHASE2
Status
Recruiting
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Conditions

  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia With Myelodysplasia-Related Changes
  • Acute Myeloid Leukemia With Variant MLL Translocations
  • B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
  • Chemotherapy-Related Leukemia
  • Chronic Myelomonocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • ISS Stage II Plasma Cell Myeloma
  • ISS Stage III Plasma Cell Myeloma
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome With Excess Blasts
  • Myelodysplastic Syndrome With Gene Mutation
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Hodgkin Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Adult Acute Lymphoblastic Leukemia
  • Secondary Acute Myeloid Leukemia
  • Therapy-Related Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
15 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Natural Killer Cell Line NK-92 — BIOLOGICAL
    Given IV
  • Anti-Thymocyte Globulin — BIOLOGICAL
    Given IV
  • Busulfan — DRUG
    Given IV
  • Clofarabine — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Melphalan — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Total-Body Irradiation — RADIATION
    Undergo total body irradiation
  • Umbilical Cord Blood Transplantation — PROCEDURE
    Undergo umbilical cord blood transplantation

Study Details

This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1/x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2/C2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.

Key Dates

Start date
May 19, 2016
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Myeloablative regimen 1
    Patients receive anti-thymocyte globulin IV over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo TBI on day -3. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.
  • Experimental: Non-myeloablative regimen 2
    Patients with CD20 positive malignancies receive rituximab IV over 6 hours on day -9. Patients receive anti-thymocyte globulin IV over 4 hours on days -8 and -7, fludarabine phosphate IV over 1 hour on days -6 to -3, and cyclophosphamide IV over 3 hours on day -6 and undergo TBI on day -1 at the discretion of the investigator(s). UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.
  • Experimental: Reduced intensity regimen 3
    Patients receive anti-thymocyte globulin IV over 4 hours on days -7 and -6, fludarabine phosphate IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on day -2. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo umbilical cord blood transplantation on day 0. NK CELLS INFUSION: Patients receive NK cells IV over 30 minutes between days 30-180.

Primary Outcome Measure

Progression free survival (PFS) time in C2C2 patients [ Time Frame: From the date of engraftment to disease progression or death, assessed up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Warren B Fingrut, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

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