RECRUITING

Personalized NK Cell Therapy in CBT

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Conditions

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAcute Biphenotypic LeukemiaAcute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia in RemissionAcute Myeloid Leukemia With Myelodysplasia-Related ChangesAcute Myeloid Leukemia With Variant MLL TranslocationsB Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1Chemotherapy-Related LeukemiaChronic Myelomonocytic LeukemiaChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveHigh Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsISS Stage II Plasma Cell MyelomaISS Stage III Plasma Cell MyelomaMyelodysplastic SyndromeMyelodysplastic Syndrome With Excess BlastsMyelodysplastic Syndrome With Gene MutationMyelodysplastic/Myeloproliferative NeoplasmPreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Hodgkin LymphomaRecurrent Non-Hodgkin LymphomaRefractory Acute Lymphoblastic LeukemiaRefractory Adult Acute Lymphoblastic LeukemiaSecondary Acute Myeloid LeukemiaTherapy-Related Myelodysplastic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Personalized NK Cell Therapy in CBT

Quick Facts

Study Start:2016-05-19
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02727803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \[abn\]\[3q\], -5/5q-, -7/7q-, abn\[12p\], abn\[17p\], myeloid/lymphoid or mixed-lineage leukemia \[MLL\] gene re-arrangement and t \[6;9\]47, fms related tyrosine kinase 3 \[flt3\] mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from myelodysplastic syndromes (MDS), any disease beyond first remission
  2. * Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS/myeloproliferative syndromes, 8) complex karyotype, abn(3g), -5/5g-, -7/7g-, abn(12p), abn(17p)
  3. * Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma
  4. * Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible
  5. * Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy
  6. * Chronic myeloid leukemia (CML) second chronic phase or accelerated phase
  7. * Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease
  8. * Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment
  9. * A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure
  10. * Patient age criteria: age \>= 15 and =\< 45 years (myeloablative regimen 1; age \>= 15 and =\< 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \>= 15 and =\< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3
  11. * Performance score of at least 60% by Karnofsky
  12. * Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)
  13. * Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)
  14. * Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)
  15. * Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \[GFR\]) \> 40mL/min/1.73 m\^2
  16. * Serum glutamate pyruvate transaminase (SGPT)/bilirubin \< to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT/bilirubin \< to 4.0 x normal (nonmyeloablative regimen 2)
  17. * Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months
  18. * Patients with options for treatment that are known to be curative are not eligible
  19. * Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)
  1. * Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing
  2. * Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \[CB\] transplantation is proposed), or psychiatric condition that would limit informed consent
  3. * Active central nervous system (CNS) disease in patient with history of CNS malignancy
  4. * Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor

Contacts and Locations

Study Contact

Amanda Olson, MD
CONTACT
alolson@mdanderson.org

Principal Investigator

Amanda Olson, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Amanda Olson, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05-19
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2016-05-19
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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