NK Cells in Cord Blood Transplantation
Natural Killer Cells in Allogeneic Cord Blood Transplantation
3 other identifiers
interventional
13
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2012
CompletedFirst Posted
Study publicly available on registry
June 14, 2012
CompletedStudy Start
First participant enrolled
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedFebruary 11, 2020
February 1, 2020
8.5 years
June 12, 2012
February 7, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Generation of a minimum of 5 x 10^6 natural killer/kg cells in at least 60% of patients (success rate)
Will be estimated with 90% credible interval.
Up to 1 year
Treatment-related mortality
The method described by Thall, et al will be used. Will be estimated with 90% credible interval. The product-limit estimator of Kaplan and Meier will be used with 95% confidence intervals.
100 days
Incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Changes from baseline in vital signs and laboratory values will be summarized. Tabulate adverse events by severity and relationship to therapy.
Up to 1 year
Secondary Outcomes (6)
Proportion of patients with acute graft-versus-host-disease
Up to 1 year
Proportion of patients with chronic graft-versus-host-disease
Up to 1 year
Overall survival
1 year
Disease-free survival
1 year
Time to initial platelet recovery
From the infusion of peripheral blood stem cells to the first of 3 consecutive platelet count measurements tested on different days with a count greater than or equal to 20 x 10e9/L, assessed up to 1 year
- +1 more secondary outcomes
Study Arms (2)
Treatment Plan 1 (NK cells, umbilical cord blood transplant)
EXPERIMENTALPatients receive high-dose lenalidomide PO QD on days -8 to -2, fludarabine phosphate IV over 1 hour on days -7 to -4, and melphalan IV over 30 minutes on day -4. CD20 positive patients also receive rituximab IV over 6 hours on days -8 to -4.
Treatment Plan 2 (NK cells, umbilical cord blood transplant)
EXPERIMENTALPatients receive high-dose lenalidomide PO QD on days -7 to -2, cyclophosphamide IV over 3 hours on day -7, and undergo TBI on day -3. Patients also receive rituximab and fludarabine phosphate as in Treatment Plan 1.
Interventions
Undergo allogeneic umbilical cord blood transplant
Given IV
Given IV
Correlative studies
Given PO
Given IV
Given IV or PO
Given IV
Given IV
Given IV or PO
Undergo TBI
Undergo allogeneic umbilical cord blood transplant
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra Hosing
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2012
First Posted
June 14, 2012
Study Start
May 3, 2013
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
February 11, 2020
Record last verified: 2020-02