ACTIVE_NOT_RECRUITING

Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Aplastic Anemia Bone Marrow Failure Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Follicular Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Myelodysplastic Syndrome Myeloproliferative Neoplasm Non-Hodgkin Lymphoma Plasma Cell Myeloma

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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 I/II trial studies how well cytokine-treated veto cells work in treating patients with hematologic malignancies following stem cell transplant. Giving chemotherapy and total-body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem 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. Cytokine-treated veto cells may help the transplanted donor cells to develop and grow in recipients without causing graft-versus-host-disease (GVHD - when transplanted donor tissue attacks the tissues of the recipient's body).

Official Title

Anti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell Transplantation

Quick Facts

Study Start:2019-08-08

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03622788

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:12 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 12-75 years. The first 3 subjects will be 18 years of age to gain experience and observe safety. After 3 adult subjects have successfully engrafted and if the safety profile is tolerable, adolescents age 12 may be enrolled on to the trial * Patients with a diagnosis either follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), Hodgkin's lymphoma (HL), non-Hodgkin's lymphoma (NHL), chronic myeloid leukemia (CML), myelodysplastic syndrome, myeloproliferative syndromes (MPD), acute myeloid leukemia (AML) or acute lymphoid leukemia (ALL). * Patients with aplastic anemia and severe immune deficiency or nonmalignant bone marrow failure states. Patients with severe thalassemia requiring regular blood transfusions or sickle cell disease with severe clinical features (these include any clinically significant sickle genotype, for example, hemoglobin SS (Hb SS), hemoglobin SC (Hb SC), hemoglobin S beta thalassemia (Hb Sbeta), or Hemoglobin S-OArab genotype\] with at least one of the following manifestations: * Clinically significant neurologic event (stroke) or neurological deficit lasting \> 24 hours; * History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment or referral despite adequate supportive care measures (i.e. asthma therapy); * An average of three or more pain crises per year in the 2-year period preceding enrollment or referral (required intravenous pain management in the outpatient or inpatient hospital setting); * Administration of regular red blood cell (RBC) transfusion therapy, defined as 8 or more transfusion events per year (in the 12 months before enrollment) to prevent vaso-occlusive clinical complications (i.e. pain, stroke, or acute chest syndrome); * An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity \>= 2.7 m/sec. * Ongoing high impact1 chronic pain on a majority of days per month for \>= 6 months as defined as ONE or more of the following: Chronic pain without contributory sickle cell disease (SCD) complications2, OR mixed pain type in which chronic pain is occurring at site(s) (arms, back, chest, or abdominal pain) unrelated to any sites associated with contributory SCD complications2 (e.g. leg ulcers and/or avascular necrosis) * Patients with hematological malignancies must have had persistent or progressive disease despite initial chemotherapy and must have achieved stable disease or a partial or complete response to their most recent chemotherapy. Patients with low bulk or indolent relapse are eligible without additional treatment. Patients with high-risk acute myeloid leukemia by European LeukemiaNet (ELN) criteria in first remission are eligible. * Availability of a medically acceptable haploidentical related donor, age 12-70 years. * Karnofsky performance status \>= 70%. * Left ventricular ejection fraction of at least 40%. * Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration. * Serum creatinine =\< 1.5 mg/dl. * Serum glutamic-pyruvic transaminase (SGPT) =\< 200 IU/ml. * Bilirubin \< 1.5 mg/dl (unless Gilbert's syndrome). * Negative pregnancy test in a woman with childbearing potential.	* Human immune deficiency virus (HIV) seropositive. * Uncontrolled infection or serious medical or psychiatric condition that would limit tolerance to the protocol treatment. * Active central nervous system (CNS) malignancy. * Availability of medically eligible, human leukocyte antigen (HLA)-matched related stem cell donor. * Medically acceptable haploidentical donor age 12-70 years. * Hemoglobin \> 12.0 g/dL \[female\] or \> 13.0 g/dL \[male\] or \> 11.0 g/dL for females of childbearing potential with documented iron deficiency anemia * Platelet count 150, 0000/ul * WBC 3.0 - 11.0 K/ul * No anomalies on CBC and differential indicating a hematopoietic disorder * Negative pregnancy test for women of childbearing potential; Not lactating * Systolic blood pressure \< 170 mmHg and Diastolic blood pressure \< 95 mmHg * Performance status KPS \> 70% * CXR negative for active infection or malignancy * EKG not suggestive of uncontrolled cardiac disease * No known allergy to cytokines if cytokines are to be used. * No active or uncontrolled autoimmune disorders * Completion and signature of donor questionnaire (within 30 days) * Donor infectious disease panel and health assessment performed by attending physician * Individuals with cognitive impairments and/or any serious unstable pre-existing condition or psychiatric disorder that can interfere with safety or without obtaining informed consent or compliance with study procedures.

Inclusion Criteria

Exclusion Criteria

* Age 12-75 years. The first 3 subjects will be 18 years of age to gain experience and observe safety. After 3 adult subjects have successfully engrafted and if the safety profile is tolerable, adolescents age 12 may be enrolled on to the trial
* Patients with a diagnosis either follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), Hodgkin's lymphoma (HL), non-Hodgkin's lymphoma (NHL), chronic myeloid leukemia (CML), myelodysplastic syndrome, myeloproliferative syndromes (MPD), acute myeloid leukemia (AML) or acute lymphoid leukemia (ALL).
* Patients with aplastic anemia and severe immune deficiency or nonmalignant bone marrow failure states. Patients with severe thalassemia requiring regular blood transfusions or sickle cell disease with severe clinical features (these include any clinically significant sickle genotype, for example, hemoglobin SS (Hb SS), hemoglobin SC (Hb SC), hemoglobin S beta thalassemia (Hb Sbeta), or Hemoglobin S-OArab genotype\] with at least one of the following manifestations:
* Clinically significant neurologic event (stroke) or neurological deficit lasting \> 24 hours;
* History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment or referral despite adequate supportive care measures (i.e. asthma therapy);
* An average of three or more pain crises per year in the 2-year period preceding enrollment or referral (required intravenous pain management in the outpatient or inpatient hospital setting);
* Administration of regular red blood cell (RBC) transfusion therapy, defined as 8 or more transfusion events per year (in the 12 months before enrollment) to prevent vaso-occlusive clinical complications (i.e. pain, stroke, or acute chest syndrome);
* An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity \>= 2.7 m/sec.
* Ongoing high impact1 chronic pain on a majority of days per month for \>= 6 months as defined as ONE or more of the following: Chronic pain without contributory sickle cell disease (SCD) complications2, OR mixed pain type in which chronic pain is occurring at site(s) (arms, back, chest, or abdominal pain) unrelated to any sites associated with contributory SCD complications2 (e.g. leg ulcers and/or avascular necrosis)
* Patients with hematological malignancies must have had persistent or progressive disease despite initial chemotherapy and must have achieved stable disease or a partial or complete response to their most recent chemotherapy. Patients with low bulk or indolent relapse are eligible without additional treatment. Patients with high-risk acute myeloid leukemia by European LeukemiaNet (ELN) criteria in first remission are eligible.
* Availability of a medically acceptable haploidentical related donor, age 12-70 years.
* Karnofsky performance status \>= 70%.
* Left ventricular ejection fraction of at least 40%.
* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration.
* Serum creatinine =\< 1.5 mg/dl.
* Serum glutamic-pyruvic transaminase (SGPT) =\< 200 IU/ml.
* Bilirubin \< 1.5 mg/dl (unless Gilbert's syndrome).
* Negative pregnancy test in a woman with childbearing potential.

* Human immune deficiency virus (HIV) seropositive.
* Uncontrolled infection or serious medical or psychiatric condition that would limit tolerance to the protocol treatment.
* Active central nervous system (CNS) malignancy.
* Availability of medically eligible, human leukocyte antigen (HLA)-matched related stem cell donor.
* Medically acceptable haploidentical donor age 12-70 years.
* Hemoglobin \> 12.0 g/dL \[female\] or \> 13.0 g/dL \[male\] or \> 11.0 g/dL for females of childbearing potential with documented iron deficiency anemia
* Platelet count 150, 0000/ul
* WBC 3.0 - 11.0 K/ul
* No anomalies on CBC and differential indicating a hematopoietic disorder
* Negative pregnancy test for women of childbearing potential; Not lactating
* Systolic blood pressure \< 170 mmHg and Diastolic blood pressure \< 95 mmHg
* Performance status KPS \> 70%
* CXR negative for active infection or malignancy
* EKG not suggestive of uncontrolled cardiac disease
* No known allergy to cytokines if cytokines are to be used.
* No active or uncontrolled autoimmune disorders
* Completion and signature of donor questionnaire (within 30 days)
* Donor infectious disease panel and health assessment performed by attending physician
* Individuals with cognitive impairments and/or any serious unstable pre-existing condition or psychiatric disorder that can interfere with safety or without obtaining informed consent or compliance with study procedures.

Contacts and Locations

Principal Investigator

Richard E Champlin

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

Richard E Champlin, 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 Date2019-08-08

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2019-08-08

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Aplastic Anemia
Bone Marrow Failure
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Follicular Lymphoma
Hodgkin Lymphoma
Mantle Cell Lymphoma
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Plasma Cell Myeloma