Personalized NK Cell Therapy After Chemotherapy and Cord Blood Transplant for Blood Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02727803

Provider View

This study is testing a personalized treatment using natural killer (NK) cells after chemotherapy and umbilical cord blood transplant to see if it helps treat blood cancers like leukemia, lymphoma, and multiple myeloma. The goal is to see if NK cells can kill remaining cancer cells and reduce the risk of complications after transplant.

Patient Parameters

Program Overview

This phase II clinical trial is exploring how well a personalized natural killer (NK) cell therapy works when given after chemotherapy and umbilical cord blood transplant in patients with certain blood cancers, including myelodysplastic syndrome, leukemia, lymphoma, or multiple myeloma. The study will test a method of selecting cord blood based on specific genetic markers and using NK cells derived from cord blood to target cancer cells. NK cells are a type of immune cell that may help eliminate cancer cells left in the body after chemotherapy and reduce the risk of graft versus host disease, a common complication after cord blood transplant.

Description

The main goal of this study is to see how long patients can live without their cancer getting worse (progression-free survival). Other goals include measuring overall survival, transplant-related mortality, and the occurrence of graft versus host disease and infections.

Patients will be assigned to one of three treatment plans:

  1. Myeloablative Regimen 1: Patients receive several chemotherapy drugs and total body irradiation before the transplant.
  2. Non-Myeloablative Regimen 2: Patients with certain types of cancer receive a different set of chemotherapy drugs and possibly total body irradiation.
  3. Reduced Intensity Regimen 3: Patients receive a lighter chemotherapy treatment.

All patients will undergo an umbilical cord blood transplant. Afterward, they will receive NK cells through an IV infusion between 30 to 180 days after the transplant.

Patients will be monitored closely with follow-up visits at various intervals up to four years to track their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a specific type of blood cancer, such as acute myelogenous leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, Hodgkin's disease, or multiple myeloma.
  • Must have a backup source of cells, like a family member or cord blood, in case the transplant doesn't work.
  • Must be between 15 and 45 years old for the myeloablative regimen, or between 15 and 80 years old for the other regimens.
  • Must have a performance score of at least 60%.
  • Must have adequate heart and lung function.
  • Must have normal kidney and liver function.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must not have other treatment options that are known to cure the cancer.
  • May be enrolled in other supportive care studies.

Exclusion Criteria

  • Cannot be HIV positive.
  • Cannot have uncontrolled serious medical conditions, such as severe infections or heart failure.
  • Cannot have active central nervous system disease if there is a history of CNS cancer.
  • Cannot have a suitable, willing, HLA-matched related stem cell donor available.

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