CD22CART cell infusion for Leukemia, Hairy Cell

Phase-Based Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Leukemia, Hairy Cell+3 More
CD22CART cell infusion - Biological
Eligibility
18+
All Sexes
Eligible conditions
Leukemia, Hairy Cell

Study Summary

Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant

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Eligible Conditions

  • Leukemia, Hairy Cell
  • Leukemia
  • Hairy Cell Leukemia (HCL)
  • Hairy Cell Leukemia Variant

Treatment Effectiveness

Study Objectives

This trial is evaluating whether CD22CART cell infusion will improve 2 primary outcomes and 7 secondary outcomes in patients with Leukemia, Hairy Cell. Measurement will happen over the course of end of treatment.

end of treatment
safety and feasibility
Year 15
MRD negative CR
antitumor effect
duration of response
event free survival
progression free-survival
time to next treatment
Year 5
expansion and persistence
Year 15
overall survival

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Experimental therapy: Dose Escalation

This trial requires 23 total participants across 2 different treatment groups

This trial involves 2 different treatments. CD22CART Cell Infusion is the primary treatment being studied. Participants will be divided into 2 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.

Experimental therapy: Dose EscalationEscalating doses of autologous anti-CD22-CAR T-cells in subjects to determine the MTD
Experimental therapy: Dose ExpansionAutologous anti-CD22-CAR T-cells at the MTD

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every year for 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly every year for 5 years for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Hairy Cell 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:
Hemoglobin <10g/dL
Platelets<100/nL
Symptomatic splenomegaly
Enlarging HCL mass or bone lesion > 2cm in short axis
HCLv count doubling time <3 months
Increasing lytic or blastic bone lesions
HCL/HCLv, after prior treatment with, ineligible for, refusal of, or inability to obtain 1) Rituximab given concurrently with or sequentially after purine analog, 2) moxetumomab pasudotox-tdft, and 3) BRAF-inhibition.
The absolute neutrophil count (ANC) is less than 1/nL. show original
You have a HCL count of at least 5/nL. show original
Participants who have eligible blood counts within 4 weeks from the initiation of study will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment. 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.

What causes leukemia, hairy cell?

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In this case-control study two major risk factors have been identified. These are acute childhood infections, particularly measles in infancy, and chronic hematologic diseases such as [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) or myelodysplastic syndromes and other leukemia subtypes. Findings from a recent study support the previous finding that the development of nonlymphocytic leukemia is linked to acute infectious or immunogenic processes.

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How many people get leukemia, hairy cell a year in the United States?

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[In the United States]<br> 1,000 people get hairy cell leukemia a year. [In 2011 and 2012], the rates of hairy cell leukemia are increasing for both women and men aged 20 or older. In 2011, hairy cell leukemia deaths in men aged 20 and older accounted for approximately 25% of all US hairy cell leukemia deaths, a rate similar to those seen in the UK and the Nordic countries. By comparison, the rate of hairy cell leukemia deaths among women aged 20 and older was 3% higher.

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Can leukemia, hairy cell be cured?

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The outlook for hairy cell leukemia is good despite the disease being very sensitive to current treatment options. In hairy cell leukemia, early diagnosis is crucial for successful and appropriate treatment.

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What are the signs of leukemia, hairy cell?

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Results from a recent paper demonstrated that patients and caregivers have few symptoms of leukemia, even in the presence of substantial disease. Patients, relatives, and healthcare providers should concentrate on the physical exam, and medical history for early identification of the signs and symptoms. A thorough medical history of signs and symptoms, and careful laboratory examinations are critical to the early diagnosis of leukemia.

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What is leukemia, hairy cell?

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It is a type of blood cancer in which a normal bone marrow does not produce normal blood cells. It is a form of mature lymphocyte marrow leukemia. It occurs mostly in the elderly, especially the adult male population. The exact cause of hairy cell leukemia is not known, but one theory suggests that it is caused by a mutated retrovirus.\n

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What are common treatments for leukemia, hairy cell?

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Most treatments have been tested in several different clinical settings and the quality of reporting has varied. Patient and treatment characteristics influence the results and clinicians should aim to assess the quality whenever a treatment for leukemia is being recommended. The effectiveness of treatments in patients with leukemia and other cancers should be evaluated using similar quality-of-evidence guidelines for a single disease entity.

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What is the survival rate for leukemia, hairy cell?

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Survival rate varies, but most leukemias have high recurrence rates due to the long latency period. Treating hairy cell leukemias should not be delayed, or it is very unlikely that survival lasts more than 1–2 years. In this group of patients, survival rate can be accomplished if one is able to identify all of the patient's cells containing the Epstein-Barr virus with the use of rituximab or similar drugs.

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Have there been any new discoveries for treating leukemia, hairy cell?

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The research in the last ten years has provided novel methods of targeted therapy for this deadly cancer. At present there is no compelling clinical evidence to corroborate the benefit of these therapies in [hairy cell leukemia](https://www.withpower.com/clinical-trials/hairy-cell-leukemia). New avenues for research targeting leukemia, particularly BCR-ABL, c-AKT, PTKs, and RAS genes, have begun. More research is needed to substantiate the benefit of these treatments. Clinical trials at the forefront of research into hairy cell leukemia include MIRACL, E-ZENO, CALGB 40303, and ALL-GEM.

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Have there been other clinical trials involving cd22cart cell infusion?

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Clinical trials have been conducted to evaluate the efficacy of CD22cart cell infusion for patients with relapsed or refractory MEC, myelodysplastic syndrome, or solid tumors, including non-Hodgkin's lymphoma, prostate, breast, and head and neck cancers. Although the efficacy, safety, and durability of these treatments are still undefined, the recent identification of the CD22cart cell antigen as a target for immune-based therapies may have significant implications in the treatment of relapsed and refractory MEC and other peripheral B-cell malignancies.

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How quickly does leukemia, hairy cell spread?

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The hairy cell spread is a problem, and can be a cause for death for some patients in chronic phase, especially if [leukemia treatment is prolonged>2 years]. You've already seen that when hairy cell spread is found, it tends to [move faster] after a short time. If you do not see anything different after 12 months[for which you may or may not take your [leukemia medicine for 3 months by mouth], it means there may be a problem. You may need to [begin to take leukemia medicine again] after 5 years, according to how quickly the hairy cell grew.

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What is the primary cause of leukemia, hairy cell?

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Hairy cell leukemia may be an acute lymphocytic leukemia with clonal rearrangement of the immunoglobulin heavy-chain gene, usually involving the IgH region. This is thought to be caused either by a genetic error or some environmental cause. The latter could be a cigarette, medication, or virus. There is also an increased risk of developing hairy cell leukemia in people who have previously been diagnosed with myeloma or multiple myeloma. For adults with hairy cell leukemia, the best treatment to date is to discontinue treatment unless there are [serious complications ](https://www.withpower.

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How does cd22cart cell infusion work?

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Cd22cart (CD22-targeted radioimmunotherapy) represents a novel therapeutic option to target CLL cells by targeting the CD22 antigen which is overexpressed on almost all chronic lymphocytic malignancies.

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