Long-term Safety of UCART19 for Leukemia

Recruiting at 16 trial locations

Overseen By Institut de Recherches Internationales Servier

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Institut de Recherches Internationales Servier

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the UCART19 treatment for leukemia differ from other treatments?

UCART19 is a unique treatment for leukemia because it involves genetically engineered T-cells (a type of immune cell) that are designed to specifically target and destroy cancer cells, offering a novel approach compared to traditional chemotherapy or bone marrow transplantation. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.

Research Team

Reuben Benjamin

Principal Investigator

King's College Hospital NHS Trust

Eligibility Criteria

This trial is for patients with advanced lymphoid leukemia who have previously received UCART19, either through a past study or compassionate use. Participants must agree to effective birth control for 12 months post-treatment and provide written consent.

Inclusion Criteria

Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)

I have previously been treated with UCART19.

I am using effective birth control and will continue for 12 months after my last treatment.

Exclusion Criteria

No exclusion criteria for this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants previously administered with UCART19 are monitored for safety and efficacy

12 months

Follow-up

Participants are monitored for long-term safety and effectiveness after treatment

Up to 15 years

Treatment Details

Interventions

• UCART19

Trial Overview The study focuses on the long-term safety and effectiveness of UCART19 in individuals with advanced lymphoid leukemia. It's a follow-up evaluation for those who've already been treated with this intervention.

Participant Groups

Group I: UCART19 follow-up Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Institut de Recherches Internationales Servier

Lead Sponsor

Trials

91

Recruited

67,100+

ADIR, a Servier Group company

Industry Sponsor

Trials

33

Recruited

4,300+

Findings from Research

Over 20 years, 250 adults with acute lymphoblastic leukemia (ALL) were treated with various multidrug protocols, with the L10 and L10M protocols showing the highest long-term remission rates of 52% and 40%, respectively, compared to more recent protocols.

The overall long-term survival rate was 31%, with 35% of patients achieving complete remission remaining relapse-free for over 5 years, indicating that early remission is crucial for improving survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of long-term follow-up in evaluating treatment regimens for adults with acute lymphoblastic leukemia. Clarkson, B., Gaynor, J., Little, C., et al.[2019]

The VALOR study, involving 711 patients, showed that the combination of vosaroxin and cytarabine resulted in better complete remission rates and survival for older patients (≥60 years) with relapsed/refractory acute myeloid leukemia (AML) compared to placebo/cytarabine.

Vosaroxin demonstrated a safety profile similar to existing AML treatments, making it a promising option for older patients who often face poor outcomes due to comorbidities and unfavorable cytogenetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vosaroxin in relapsed/refractory acute myeloid leukemia: efficacy and safety in the context of the current treatment landscape. Sedov, V., Stuart, RK.[2020]

Since 2017, the FDA has approved nine new agents for treating acute myeloid leukemia (AML), marking significant progress in AML therapy after decades of slow advancement.

Specific treatments for subsets of AML, such as all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia, have led to impressive 10-year survival rates of over 80%, demonstrating the efficacy of targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute myeloid leukemia: Treatment and research outlook for 2021 and the MD Anderson approach. Kantarjian, HM., Kadia, TM., DiNardo, CD., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Importance of long-term follow-up in evaluating treatment regimens for adults with acute lymphoblastic leukemia. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Use of endpoints in phase III randomized controlled trials for acute myeloid leukemia over the last 15 years: a systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Vosaroxin in relapsed/refractory acute myeloid leukemia: efficacy and safety in the context of the current treatment landscape. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges of clinical trial design for targeted agents against pediatric leukemias. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Acute myeloid leukemia: Treatment and research outlook for 2021 and the MD Anderson approach. [2021]