Cytokine-treated veto cells for patients with blood cancers after stem cell transplant
Anti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell Transplantation
This study is testing if special cells treated with cytokines can help patients with blood cancers recover better after a stem cell transplant without causing serious side effects.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03622788 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial investigates the effectiveness of cytokine-treated veto cells in treating patients with hematologic malignancies following a stem cell transplant. The study aims to determine the optimal dose of these cells that can achieve successful engraftment without causing severe graft-versus-host disease (GVHD). Patients will undergo a conditioning regimen involving chemotherapy and total body irradiation before receiving the transplant, followed by administration of the veto cells to support the growth of donor stem cells. The trial will monitor various outcomes, including toxicity, response rates, and overall survival over a year.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12-75 with hematologic malignancies or severe bone marrow failure conditions who are undergoing stem cell transplantation.
Not a fit: Patients with conditions not related to hematologic malignancies or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the success rates of stem cell transplants for patients with hematologic malignancies while minimizing the risk of GVHD.
How similar studies have performed: While this approach is innovative, similar studies exploring cytokine-treated cells have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion 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. Patient Exclusion Criteria: * 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. Donor Inclusion Criteria * 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 Donor Exclusion Criteria * 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Richard E Champlin — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.