ApoGraft for Haploidentical Hematopoietic Stem Cell Transplant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Haploidentical Hematopoietic Stem Cell Transplant+2 More
ApoGraft - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new treatment may help reduce complications for individuals who need a stem cell transplant.

See full description

Eligible Conditions

  • Haploidentical Hematopoietic Stem Cell Transplant
  • Acute Graft-Versus-Host Disease (GVHD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Haploidentical Hematopoietic Stem Cell Transplant

Study Objectives

This trial is evaluating whether ApoGraft will improve 1 primary outcome and 12 secondary outcomes in patients with Haploidentical Hematopoietic Stem Cell Transplant. Measurement will happen over the course of From day 0 to 1 year post-transplantation of ApoGraft product.

35 days post haplo-HCT
Cumulative incidence of graft failure
Rate of neutrophil engraftment as determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Rate of platelet engraftment determined by number of days for reaching first measurement of 3 consecutive measurements with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Rate of platelet engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time of neutrophil engraftment as determined by number of days for reaching first of 3 consecutive days with ANC ≥ 500/mm3
Time of platelet engraftment determined by number of days for reaching first measurement of 3 consecutive measurements with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Time of platelet engraftment determined by number of days for reaching first of 3 consecutive days with platelets ≥ 20,000/mm3 in the absence of platelet administration during the prior 7 days
Day 180
Incidence of Grade 2-4 acute GVHD
Incidence of Grade 3-4 acute GVHD
Time to development of Grade 2-4 acute GVHD
Time to development of Grade 3-4 acute GVHD
Year 1
Safety and tolerability of ApoGraft as measured by adverse events related to ApoGraft product
Year 1
Treatment related mortality

Trial Safety

Safety Progress

1 of 3

Other trials for Haploidentical Hematopoietic Stem Cell Transplant

Trial Design

2 Treatment Groups

Donor
1 of 2
Recipient
1 of 2
Active Control
Experimental Treatment

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. ApoGraft 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.

Recipient
Drug
Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy which will be administered at the discretion of the treating physician Recipients will undergo a single fresh ApoGraft transplant as per standard clinical site guidelines
Donor-Donors will undergo apheresis from peripheral blood after daily G-CSF administration (for up to 5 days prior to Day -1)

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through 1 year post-transplantation of apograft product
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through 1 year post-transplantation of apograft product for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult male or female subjects, 18-70 years of age.
Availability of an HLA-haploidentical-HSCT related donor with a minimum match of 5/10 at the HLA A, B, C, DR and DQ loci.
Acute myelogenous leukemia (AML) and Acute lymphoblastic leukemia (ALL) in 1st or subsequent complete remission (CR)
Non-Hodgkin's Lymphoma (NHL) in CR by CT or PET/CT
Hodgkin's disease (HD) in 1st or subsequent CR by CT or PET/CT
Intermediate or high risk Myelodysplastic syndrome (MDS) (IPSS-R criteria)
ECOG performance status score 0-1 at time of the screening visit
Cardiac left ventricular ejection fraction ≥ 40% in adults within 90 days of start of lymphodepleting chemotherapy
Pulmonary function test with DLCO, FEV1 and FVC of ≥ 50% within 90 days of start of lymphodepleting chemotherapy.
Oxygen saturation ≥ 90% on room air at screening visit.

Patient Q&A Section

What causes graft vs host disease?

"The causes of graft vs host disease are not known but have been well recognized by patients and doctors for decades; it is, therefore, a great medical mystery. There is still no definite cause and the search continues. In the most recent decade, the role of genetic variants and the role of T Lymphocytes in G v H disease have received some attention. New concepts of immune regulation that seem to be relevant to G v H disease are now being explored. The study of graft vs host disease on a genetic level may lead to a breakthrough in the understanding of this debilitating disease, since until now the only known remedies and treatments have been symptomatic and have done very little to cure G v H disease." - Anonymous Online Contributor

Unverified Answer

Can graft vs host disease be cured?

"Graft vs host disease can be cured in the absence of bone marrow transplantation. The best available methodology should be used to find the cause of the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of graft vs host disease?

"The presence of skin rash, fevers of unexplained origin, and conjuctivitis are commonly seen early in the course of GvHD. Other signs of early GvHD (e.g. blood in stool, diarrhea, or epistaxis) are less common and more associated with a more severe course." - Anonymous Online Contributor

Unverified Answer

How many people get graft vs host disease a year in the United States?

"About 1 million new patients will be afflicted with GVHD a year in the United States under current circumstances. The prevalence rate of 0-4-year-old children has reached 90.9% since 2000, and the proportion with severe GVHD is now higher than 40." - Anonymous Online Contributor

Unverified Answer

What are common treatments for graft vs host disease?

"Treatment is tailored to the case and type of GVHD. The management approaches to GVHD have been refined over the last decade. The current therapies may produce the most benefits and decrease the number of severe cases. But there is still a need for more researches. There are some evidences suggesting the possible influence of new therapies in GVHD." - Anonymous Online Contributor

Unverified Answer

What is graft vs host disease?

"The first sign of graft vascular disease is opportunistic infection of the bone marrow. The first sign of the graft to host disease is the appearance of the white blood cells. It is a spectrum of clinically and histologically distinct disorders associated with the immunosuppressive therapy employed in transplantation. GvHD is a serious complication of allo-transplantation, especially with HLA-mismatched combinations of donors and recipients, and is associated with a long-lasting damage of the immune system, leading to life-threatening opportunistic infection, multiple myeloma and malignant lymphoma." - Anonymous Online Contributor

Unverified Answer

Is apograft typically used in combination with any other treatments?

"Apograft is used as a treatment in addition to another treatment in 33% of patients with acute GvHD. The patients who did not receive apograft in conjunction with another treatment had a higher incidence of transplant rejection and a lower incidence of engraftment than those who did receive apograft. For patients undergoing allogeneic stem cell transplantation apograft should not be used as a standard component of treatment, however, it is still the best available option if the graft donor is not available." - Anonymous Online Contributor

Unverified Answer

How does apograft work?

"Apograft is safe for use at all sites of HSCT. The efficacy against acute GVHD in the skin and sinuses is very marked, and this is likely due to its profound effect on activated T cells, both intra-cytotoxic and in the microenvironment of affected areas. The long-term results of this study suggest that when GVHD develops, only the adaptive response dominates, and apograft has no deleterious impact." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for graft vs host disease?

"Patients who do not meet clinical trial eligibility criteria would benefit from clinical trials of GvHD. Only those at high risk for graft versus host disease would be appropriate candidates for clinical trials of new therapies. The treatment of GvHD would be targeted according to patient's G-6-PD and CCR5-Δ32 genotype." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of graft vs host disease?

"The primary cause of graft vs host disease is an immune event, but not a genetic event. There are no differences between acute and chronic graft vs host disease, if both respond to steroids." - Anonymous Online Contributor

Unverified Answer

Is apograft safe for people?

"Use of the apograft for reconstruction after allogeneic HSCT is possible, particularly in patients with chronic GVHD. Apografted patients develop no increase in sGvHD or sAHA. For use of A-bone graft, A-spacer must be used to avoid A-Graft GVHD." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating graft vs host disease?

"New therapies are evolving to treat graft vs host disease. Though the treatment of graft vs host disease has been highly successful, there are several cases reported where a patient dies, or the disease is more symptomatic after a second transplant. For this reason, graft vs host disease can be considered a challenge and a major consideration. While multiple treatments have received attention and effort, some treatments have produced positive results and outcomes. Unfortunately, this disease is still considered to be a lifelong challenge." - 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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