Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    40
  • sponsor
    Rutgers, The State University of New Jersey
Updated on 25 May 2022
ct scan
platelet count
cancer
remission
stem cell transplantation
myeloid leukemia
lymphoid leukemia
hematologic malignancy
lymphoma
multiple myeloma
hodgkin's disease
white blood cell count
flow cytometry
residual disease
HIV Infection
cell transplantation
leukemia
lymphocytic leukemia
minimal residual disease
induction therapy
residual tumor
hepatitis b surface antigen
white blood cells
PCR test
blood transfusion
chemotherapy regimen
positron emission tomography
high-dose chemotherapy
diffuse large b-cell lymphoma
mantle cell lymphoma
hbsag
t-cell lymphoma
peripheral t-cell lymphoma
high dose chemotherapy
blood cell count
17p deletion
hiv disease

Summary

This pilot clinical trial studies the side effects of irradiated donor cells following stem cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to decrease in size and may help control cancer in patients receiving a stem cell transplant.

Description

PRIMARY OBJECTIVES:

I. To determine the toxicity associated with the administration of irradiated haploidentical cells (IHC) to patients with high-risk hematologic malignancies.

SECONDARY OBJECTIVES:

I. To determine if there is evidence of disease response associated with IHC.

TERTIARY OBJECTIVES:

I. To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.

After completion of study treatment, patients will be followed up within 8 weeks.

Details
Condition Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia in Remission, Hematopoietic Cell Transplantation Recipient, JAK2 Gene Mutation, Loss of Chromosome 17p, Mantle Cell Lymphoma, Minimal Residual Disease, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, RAS Family Gene Mutation, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Hematologic Malignancy, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Therapy-Related Acute Myeloid Leukemia, Therapy-Related Myelodysplastic Syndrome, TP53 Gene Mutation
Treatment allogeneic hematopoietic stem cell transplantation, Irradiated Allogeneic Cells
Clinical Study IdentifierNCT03272633
SponsorRutgers, The State University of New Jersey
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient with disease (stage) eligible per cohort
COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below
Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization [WHO] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy
Diffuse large cell lymphoma with ?double hit? or ?double expressor? features
Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR)
Mantle cell lymphoma not in CR1
Multiple myeloma with ONE (or more) of the following high risk features
Less than very good partial remission at time of high dose therapy
High Revised-International Staging System (R-ISS) (stage III ? 2 microglobulin >= 5.5 plus lactate dehydrogenase [LDH] > upper limit of normal [ULN] and/or del17p, t(4;14), t(14;16)) at time of diagnosis
Cytogenetics or fluorescent in situ hybridization (FISH) del17p
COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic
Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia Network [ELN]) at presentation
stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor
Diagnostic sample with either t(6;9), t(9;22), 11q23, inv 3, -5, -7, del17p, complex cytogenetics, NPMwt-flt3ITD+, OR p53 mutation (mut); patients whose samples have mutations in RUNX1 or ASXL1 are also eligible (unless the patient has favorable cytogenetics)
with one of the following disease subtypes
AML not in CR1 (including patients with morphologic CR but with incomplete recovery, CRi)
Myelodysplastic syndrome (MDS) with complex cytogenetics, 17p deletion or p53 mutation, or JAK2 or RAS mutation
AML in CR1 with measurable minimal residual disease (MRD) by molecular (e.g
Treatment-related MDS or AML
myeloid mutation profile, polymerase chain reaction [PCR] for NPM1, core-
Acute lymphoblastic leukemia (ALL) not in CR1
binding factor [CBF], mixed lineage leukemia [MLL]) or flow cytometry
ALL with MRD
Any hematologic malignancy relapsed or with persistent disease after allogeneic hematopoietic stem cell transplant
Multiple myeloma
Non-Hodgkin lymphoma (NHL) with chemoresistant disease at time of transplant
Any patient undergoing allogeneic hematopoietic stem cell transplant and an anticipated rate of relapse > 80% based upon published data and for which there is consensus amongst the Hematologic Malignancies Tumor Study Group that enrollment is appropriate
Meets standard eligibility requirements for high dose chemotherapy with autologous stem cell rescue (COHORT 1) or allogeneic hematopoietic stem cell transplant (COHORT 2) and has signed consent for those procedures
DONOR: Donor must be related to patient and be partially (>= 3/6 antigen) HLA-matched
DONOR: Donor must meet all Robert Wood Johnson (RWJ) Blood Services requirements for hematopoietic stem cell donation including
Availability of a genetic child, genetic parent or sibling as a potential HLA
Age >= 18 years old
haploidentical donor
Normal hemogram (white blood cells [WBC] 4.0-10.0 x 10^3/mm^3; platelet count 150,000 to 440,000/mm^3 ; hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54%
Not pregnant or lactating
Not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV), hepatitis B core or human T-cell lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB S ag) (-); meet other infectious disease screening criteria utilized by RWJ Blood Services
No uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes
Meet other blood bank criteria for blood product donation (as determined by RWJ Blood Center screening history and laboratory studies)

Exclusion Criteria

Non-English speaking person
Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are not eligible; patients undergoing < 10/10 HLA allele matched allogeneic transplant are not eligible
Pregnant women
DONOR: Non-English speaking person
DONOR: Pregnant women
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