Overview

NK Cells in Cord Blood Transplantation

Status:
Active, not recruiting
Trial end date:
2021-11-01
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial studies the side effects and best way to give natural killer cells and donor umbilical cord blood transplant in treating patients with hematological malignancies. Giving chemotherapy with or without total body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
American Cancer Society, Inc.
Celgene
National Cancer Institute (NCI)
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunoglobulins
Lenalidomide
Mechlorethamine
Melphalan
Mycophenolate mofetil
Mycophenolic Acid
Nitrogen Mustard Compounds
Rituximab
Tacrolimus
Vidarabine
Criteria
Inclusion Criteria:

- 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, 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
syndrome, any disease beyond first remission

- Myelodysplastic syndrome (MDS): primary or therapy related

- 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 t(9;22) or t(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

- Non-Hodgkin's lymphoma (NHL) in second or third complete remission, refractory NHL, or
relapsed NHL (including relapse post autologous hematopoietic stem cell transplant);
double hit lymphomas in first remission or more advanced disease

- Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with
progressive disease following standard therapy; patients with progressive CLL
following standard therapy who meet European Bone Marrow Transplant (EBMT) consensus
guidelines of indications for allogeneic stem cell transplantation; this includes
patients with (1) lack of response or early relapse within 1 year of receiving a
purine analog-containing treatment regimen, (2) disease relapse within 2 years of
receiving a purine analog combination therapy or after other therapies such as
autologous stem cell transplantation, and (3) CLL associated with tumor protein (p)53
mutations or deletions and/or deletion (del) (17p) requiring therapy; patients must
have chemosensitive disease with at least a partial response (PR) or stable disease
(SD) with last treatment regimen

- Chronic myeloid leukemia (CML) second chronic phase or accelerated phase

- Hodgkin's disease (HD): induction failures, second or third complete remission, or
relapse (including relapse post autologous hematopoietic stem cell transplant)

- Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring
treatment

- Performance score of at least 80% by Karnofsky or 0 to 2 Eastern Cooperative Oncology
Group (ECOG)

- Left ventricular ejection fraction greater than 45%

- Pulmonary function test (PFT) demonstrating a diffusion capacity of least 45%
predicted

- Creatinine < 1.6 mg/dL

- Serum glutamate pyruvate transaminase (SGPT) =< to 2.0 x normal

- Bilirubin =< to 2.0 x normal

- All study participants must be registered into the mandatory Revlimid Risk Evaluation
and Mitigation Strategy (REMS) program, and be willing and able to comply with the
requirements of the Revlimid REMS program

- Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the Revlimid REMS program

- Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing
potential defined as not post-menopausal for 24 months or no previous surgical
sterilization and willing to ongoing pregnancy testing while on treatment with
lenalidomide

- Woman with child bearing potential must either commit to continued abstinence from
heterosexual intercourse or begin TWO acceptable methods of birth control, one highly
effective method and one additional effective method AT THE SAME TIME, at least 4
weeks before she starts taking lenalidomide

- Men must agree to use a latex condom during sexual contact with females of child
bearing potential even if they have had a successful vasectomy

- Patients must have two CB units available which are matched with the patient at 4, 5,
or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular)
antigens; each cord must contain at least 1.5 x 10^7 total nucleated cells/Kg
recipient body weight (pre-thaw); cord blood units will be procured through the
National Marrow Donor Program (NMDP)

- Have identified a backup cells source in case of engraftment failure; the source can
be autologous, related or unrelated

- Patients who have had a prior autologous transplant are eligible

Exclusion Criteria:

- Patients with known history of human immunodeficiency virus (HIV)/acquired immune
deficiency syndrome (AIDS)

- Active central nervous system (CNS) disease in patient with history of CNS malignancy

- Patients with chronic active hepatitis or cirrhosis; if positive hepatitis serology,
the study chair may deem the patient eligible based on the results of liver biopsy

- Patients with known hypersensitivity to lenalidomide and/or rituximab

- Patients who have a matched related donor who is eligible and willing to donate stem
cells