Gamma Delta T-Cell Infusion for Leukemia, Myeloid, Acute

Phase-Based Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
Leukemia, Myeloid, Acute+3 More
Gamma Delta T-Cell Infusion - Biological
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Myeloid, Acute

Study Summary

This study is evaluating whether a single infusion of donor T-cells can be used to treat patients with AML.

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Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Gamma Delta T-Cell Infusion will improve 2 primary outcomes and 2 secondary outcomes in patients with Leukemia, Myeloid, Acute. Measurement will happen over the course of at 6 weeks.

Up to 12 months
Dose Expansion: Leukemia Free Survival
Maximum Tolerated Dose
Overall Survival (OS)
at 6 weeks
Number of Participants with Graft Versus Host Disease (GVHD)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

No Control Group
Dose Level 2

This trial requires 32 total participants across 5 different treatment groups

This trial involves 5 different treatments. Gamma Delta T-Cell Infusion is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Level 2
Biological
Participants will receive 2.5 x 107 cells/kg (1.875-3.125 x 107 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Dose Level 3
Biological
Participants will receive 1.0 x 108 cells/kg (0.75-1.25 x 108 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Dose Level 1
Biological
Participants will receive 5.0 x 106 cells/kg (3.75-6.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Treatment at Maximum Tolerated Dose
Biological
Participants will receive Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells at the dose determined to be the Maximum Tolerated Dose, administered as a single infusion
Dose Level -1
Biological
Dose Level -1 may be used as a de-escalation dose level due to Dose Limiting Toxicities (DLTs) from Dose Level 1 Participants will receive 1.0 x 106 cells/kg (0.75-1.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

Moffitt Cancer Center - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Myeloid, Acute or one of the other 3 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:
Free of symptomatic congestive heart failure or uncontrolled arrhythmia
Adequate organ function as defined per protocol
Negative serum pregnancy test
Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
Provision of signed and dated informed consent form
Agreement to adhere to Lifestyle Considerations throughout study duration
You are male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML. show original
Patients with < 5% blasts in bone marrow at the time of transplantation are allowed show original
You have a KPS of 70% or higher during the study screening. show original
You are willing to comply with all study procedures and are available for the duration of the study. show original

Patient Q&A Section

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

How serious can leukemia, myeloid, acute be?

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Overall, leukemia, myeloid, acute was found to be the most common form of leukemia in our study, and the disease had the highest rate of death. This information will help treat clinicians when discussing prognosis, treatment options, and relapse prevention with cancer patients. In addition, this information will help guide health care providers when diagnosing and treating other forms of blood cancers.

Unverified Answer

How quickly does leukemia, myeloid, acute spread?

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Symptoms are usually present before a diagnosis of AML has been made in about 20% of cases. Early suspicion should help avoid unnecessary diagnostic tests. A complete blood count may be normal early on; however, there will be an increase in white blood cells (WBCs) and platelets (PLTs) at later stages. Lymphocytes generally remain relatively stable during progression from AML to ALL.

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Have there been any new discoveries for treating leukemia, myeloid, acute?

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Treatment of patients with leukemia, myeloid, acute is still unsatisfactory, but new findings may help improve patient outcome. In particular, the role of the p53 gene in ALL has been elucidated and novel therapy strategies based on targeting this gene may be developed in the future.

Unverified Answer

What are the chances of developing leukemia, myeloid, acute?

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The risks associated with certain cancers are not well understood as all cancers fit this category. However, the overall risk of developing leukemia, myeloid, acute is quite small. This implies that if you already have leukemia it will probably progress to myeloid, acute. In contrast, if you have been diagnosed with leukemia, you should consider seeking out clinical trials as they could provide relief from the symptoms of the disease.

Unverified Answer

How many people get leukemia, myeloid, acute a year in the United States?

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Although the incidence rate of AML among people of all ages increased at nearly every stage of life, the majority of new cases occurred during childhood and early adulthood.

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Has gamma delta t-cell infusion proven to be more effective than a placebo?

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The data suggest that GdT cell infusions have no therapeutic benefit in patients with AML or MDS. Although this therapy was associated with significant toxicity, it deserves further evaluation as an option for selected high-risk AML, MDS, or ALL patients.

Unverified Answer

What is gamma delta t-cell infusion?

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Although this was a small study, we found that gamma delta T cell infusions result in stable engraftment, but do not provide any survival benefit over historical controls. However, further studies are needed before this approach can be recommended to patients with relapsing-remitting MS.

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What are the signs of leukemia, myeloid, acute?

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Leukemias, myeloid, acute are a heterogeneous group of blood cancers where the exact cause remains unknown. Symptoms usually appear suddenly and progressively, but can vary greatly between cases. In many cases, symptoms are unremarkable, but in others they can be very alarming. In other cases, specific symptoms are present before diagnosis. To summarize, the following signs are found commonly in leukemias, myeloid, acute:\n1. Weight loss\n2. Anemia\n3. Fever\n4. Fast heart rate\n5. Low white blood cell count\n6.

Unverified Answer

What does gamma delta t-cell infusion usually treat?

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The most common indications of gamma delta infusion include prophylactic treatment for patients who have already had an allogeneic stem cell transplant, high-risk patients with hematologic malignancies, and patients with intestinal T-cell lymphomas. Although data support efficacy for various diagnoses, very little evidence supports gamma delta as a treatment modality for any specific diagnosis. The available evidence suggests that gamma delta therapy adds no demonstrable benefit to standard treatments for most types of leukemias.

Unverified Answer

Is gamma delta t-cell infusion typically used in combination with any other treatments?

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The two main reasons given for using gamma delta T cell therapy were persistent disease after conventional therapy or relapse after autologous hematopoietic stem cell transplantation. In our study, we found that patients who received gamma delta T cell therapy tended not to require consolidation chemotherapy after high dose cytotoxic therapy. Gamma delta T cell therapy may be used alone or in conjunction with other therapies, depending on relapse risk and patient characteristics.

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What are the common side effects of gamma delta t-cell infusion?

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A few common side effects were observed after gamma delta T-cell infusions. Most of them were mild and reversible. In our study, only one patient had a severe allergic reaction during the infusion. Ninety percent of patients did not have any serious adverse events despite receiving high doses of gamma delta T cells. We believe that the data presented here will be helpful for further studies on gamma delta T-cell therapy.

Unverified Answer
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