αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft for Hematologic Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Hematologic Neoplasms+2 More
αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft - Biological
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new stem cell transplant technique is safe and effective.

See full description

Eligible Conditions

  • Hematologic Neoplasms
  • Pediatric Hematologic Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hematologic Neoplasms

Study Objectives

This trial is evaluating whether αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft will improve 4 primary outcomes and 20 secondary outcomes in patients with Hematologic Neoplasms. Measurement will happen over the course of Through 100 days post-transplant.

Year 2
Event free survival (EFS)
Month 24
Change in Lansky/Karnofsky performance score
Month 24
Incidence and severity of chronic GVHD
Day 42
Engraftment as measured by time to neutrophil count recovery
Day 75
Engraftment as measured by time to platelet count recovery
Over 24 months
Immune reconstitution as measured by recovery of absolute monocyte count
Immune reconstitution as measured by recovery of absolute neutrophil count
Immune reconstitution as measured by regain of function of NK cell populations
Immune reconstitution as measured by regain of function of immunoglobulin A (IgA)
Immune reconstitution as measured by regain of function of immunoglobulin G (IgG)
Immune reconstitution as measured by regain of function of immunoglobulin M (IgM)
Through 100 days post-transplant
Safety as measured by the number of events occurring within the first 100 days post-transplant
Through 24 months
Immune reconstitution as measured by regain of function of B cell populations
Immune reconstitution as measured by regain of function of T cell populations
Number of cardiac toxicities
Number of hepatic toxicities
Number of metabolic toxicities
Number of neurologic toxicities
Number of participants with infections
Number of pulmonary toxicities
Number of renal toxicities
Number of thyroid toxicities
Through day +100
Donor cell chimerism as measured by short tandem repeat analysis
Weekly through day +100
Incidence and severity of acute GVHD

Trial Safety

Safety Progress

1 of 3

Other trials for Hematologic Neoplasms

Trial Design

1 Treatment Group

ex vivo αβ-TCR/CD19 depleted haplo-hematopoietic stem cell infusion (HSCT)
1 of 1
Experimental Treatment

This trial requires 32 total participants across 1 different treatment group

This trial involves a single treatment. Αβ-TCR/CD19 Cell Depleted Haploidentical Hematopoietic Stem Cell Graft is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

ex vivo αβ-TCR/CD19 depleted haplo-hematopoietic stem cell infusion (HSCT)Patients will undergo standard of care conditioning regiment prior to HSCT On Day 0, patients will undergo infusion of the ex vivo αβ-TCR/CD19 depleted haplo-HSCT from a stimulated peripheral stem cell source per institutional standard of care. Patients whose graft has a residual CD20+ count > 1.0 x 10^5 will receive a single infusion of rituximab on Day +1 at a dose of 375 mg/m2.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly over 24 months for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Hematologic Neoplasms or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Induction failure
Relapsed or refractory disease
High allelic FLT3/ITD ratio
Monosomy 7
Monosomy 5 or Del(5q)
Any acute leukemia in CR ≥ 2
Mixed phenotype or undifferentiated leukemia in any CR
Secondary to therapy-associated leukemia in any CR
NK cell lineage leukemia in any CR
Myelodysplastic syndrome (MDS)

Patient Q&A Section

Has αβ-tcr/cd19 cell depleted haploidentical hematopoietic stem cell graft proven to be more effective than a placebo?

"T-cell depletion did not improve engraftment of T-depleted HLA-mismatched HSCTs, but it increased OS and RFS. These data support the use of T-cell depletion for GVHD prophylaxis." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hematologic neoplasms?

"This article presents a brief overview of recent hematologic malignancy research. Recent advances in the understanding of molecular genetics and cytogenetics have led to an improved prognostic assessment of patients with myeloid leukemia, lymphomas, and Hodgkin disease. These advances also define many new therapeutic targets, which will hopefully lead to the development of novel drugs and therapies." - Anonymous Online Contributor

Unverified Answer

How does αβ-tcr/cd19 cell depleted haploidentical hematopoietic stem cell graft work?

"Results from a recent clinical trial shows how TCRαβCD19(+)HSC transplantation could be used to control the emergence of T cells, thus prolonging the donor HLA-restricted T cell repertoire." - Anonymous Online Contributor

Unverified Answer

Is αβ-tcr/cd19 cell depleted haploidentical hematopoietic stem cell graft typically used in combination with any other treatments?

"Results from a recent paper of this analysis indicated that the combination of alpha beta TCR gamma delta T cell depleted haploidentical HSC transplantation with GM-CSF mobilized autograft or G-CSF mobilized autograft was associated with significantly increased incidence of acute GvHD compared with either transplant alone. Additional therapies might need to be considered for optimizing the outcome of the regimen followed by alpha beta TCR gamma delta T cell depleted haploidentical HSC transplantation." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hematologic neoplasms?

"The data suggest that some environmental exposures may be involved in the development of hematological neoplasms, but further research is needed to investigate the role of infections and other unknown factors." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hematologic neoplasms?

"Hematologic neoplasms occur at varying ages, with leukemias occurring earlier (mean ages 18.9 yrs and lymphomas occurring later (mean ages 41.3 yrs and 56.5 yrs)). The incidence of acute myelogenous leukemia is higher in adolescents than adults and there are lower incidences of acute lymphocytic leukemia, chronic lymphocytic leukemia, and myelodysplastic syndrome in young adults. There is no clear pattern of incidence by gender." - Anonymous Online Contributor

Unverified Answer

What is αβ-tcr/cd19 cell depleted haploidentical hematopoietic stem cell graft?

"A significant proportion of patients in our series had allogeneic stem cell transplantation after graft failure. We propose that such patients should be considered for an autologous stem cell transplantation strategy." - Anonymous Online Contributor

Unverified Answer

What are the signs of hematologic neoplasms?

"Hematological tumors present themselves with many different signs. Some of them are as follows: anemia, thrombocytopenia, leukopenia, lymphadenopathy, splenomegaly, and pleural effusion. Blood tests should be interpreted carefully when diagnosing these tumors because there may be other conditions besides hematological neoplasms, such as anemia, thrombocytopenia, leukemia, and infections. Patients with hematological neoplasm should strive to maintain a healthy weight, exercise regularly, and avoid alcohol intake. When treating patients with hematological neoplasms, doctors often recommend chemotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hematologic neoplasms?

"In the past decade, research on the molecular mechanisms of hematological malignancies was very active; however, most studies were still focused on the cell biology of the disease rather than on possible therapeutic approaches." - Anonymous Online Contributor

Unverified Answer

Does αβ-tcr/cd19 cell depleted haploidentical hematopoietic stem cell graft improve quality of life for those with hematologic neoplasms?

"Compared with allogeneic transplants, a high percentage (86%) of patients who received CD19(+) cells from haploidentical donors had improved HRQOL at 12 months after transplantation. These data suggest that HRQOL is improved after transplantation with donor CD19(+) cells despite the persistence of residual neoplastic cells in these individuals." - Anonymous Online Contributor

Unverified Answer

What is hematologic neoplasms?

"Hematologic neoplasms (blood cancers) include leukemia, lymphoma, myeloma, and others. By October 1, 2009, there were 49,734 persons living with these blood cancers, who had a median age of 55, and 46.2% were male. They made up 4.4% of all new cases and 5.0% of deaths reported to the Centers for Disease Control and Prevention (CDC). The most common type of blood cancer was myeloma, representing 26.3% of all new cases and 10.9% of all deaths. Leukemia comprised 19.1% and 16.6%, respectively. Lymphoma was next with 10.8% of new cases and 7." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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