Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant
NCT ID: NCT03622788
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2019-08-08
2027-12-01
Brief Summary
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Detailed Description
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I. To determine the optimal dose of anti-viral veto cells, defined as the dose which achieves engraftment without severe graft-vs-host disease (GVHD) at 42 days after non-myeloablative megadose T cell depleted haploidentical hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. Toxicity. II. Response rate. III. Time to progression. IV. Infections. V. Immune reconstitution. VI. Overall survival up to 1 year.
OUTLINE: This is a dose-escalation study of cytokine-treated veto cells.
CONDITIONING REGIMEN: Patients receive anti-thymocyte globulin (ATG) intravenously (IV) over 4 hours on days -9 to -7 and fludarabine IV over 1 hour on days -6 to -3, then undergo total body irradiation (TBI) on day -1.
TRANSPLANT: Patients undergo peripheral blood stem cell transplantation (PBSCT) IV over 30-60 minutes on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days +3 and +4 and cytokine-treated veto cells IV over 30-60 minutes on day +7.
After completion of stem cell transplant, patients are followed up once a week for 4 weeks, once a month for 3 months, and then periodically for one year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy, PBSCT, cytokine-treated veto cells)
CONDITIONING REGIMEN: Patients receive ATG IV over 4 hours on days -9 to -7, and fludarabine IV over 1 hour on days -6 to -3, then undergo TBI on day -1.
TRANSPLANT: Patients undergo PBSCT IV over 30-60 minutes on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days +3 and +4 and cytokine-treated veto cells IV over 30-60 minutes on day +7.
Anti-Thymocyte Globulin
Given IV
Cyclophosphamide
Given IV
Cytokine-treated Veto Cells
Given IV
Fludarabine
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo PBSCT
Total-Body Irradiation
Undergo TBI
Interventions
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Anti-Thymocyte Globulin
Given IV
Cyclophosphamide
Given IV
Cytokine-treated Veto Cells
Given IV
Fludarabine
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo PBSCT
Total-Body Irradiation
Undergo TBI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
Exclusion Criteria
* 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.
* 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.
12 Years
75 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Richard E Champlin
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2018-01557
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0221
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0221
Identifier Type: -
Identifier Source: org_study_id