30 Participants Needed

Second Infusion of Tisagenlecleucel for Acute Lymphoblastic Leukemia

Recruiting at 5 trial locations
KC
Kavitha Ramaswamy profile photo
Overseen ByKavitha Ramaswamy
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if using the body's own immune system can help patients with a specific type of leukemia stay in a stable condition. It also looks at the safety and effectiveness of this approach. The treatment works by boosting the body's own immune system to better fight cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is Tisagenlecleucel generally safe for humans?

Tisagenlecleucel has been used in various conditions and has shown a manageable safety profile, but it can cause serious side effects. Common issues include cytokine release syndrome (a severe immune reaction), fever, and low blood pressure. Some cases have resulted in hospitalization or even death, mainly due to disease progression, but further studies are needed to understand long-term safety.12345

How is the treatment Tisagenlecleucel unique for acute lymphoblastic leukemia?

Tisagenlecleucel is a unique treatment for acute lymphoblastic leukemia because it uses the patient's own T-cells, which are genetically modified to target and destroy cancer cells, offering a personalized approach for those who have not responded to other treatments.12678

What data supports the effectiveness of the treatment Tisagenlecleucel for Acute Lymphoblastic Leukemia?

Tisagenlecleucel has shown high initial response rates in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia, with 83.3% of patients experiencing a complete response. However, nearly half of these patients experienced a relapse, indicating that while the treatment is initially effective, long-term outcomes may vary.124910

Who Is on the Research Team?

Kevin J. Curran, MD - MSK Pediatric ...

Kevin Curran

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and young adults under 26 with B-cell Acute Lymphoblastic Leukemia who've had a previous tisagenlecleucel infusion. They must have normal organ function, no severe ongoing side effects from the first treatment, and not be pregnant or breastfeeding. Participants need to agree to use contraception if applicable.

Inclusion Criteria

Peripheral blood B-cell aplasia within 14 days prior to reinfusion
My recent tests show no cancer signs in my bone marrow.
My CAR T cell therapy is considered out of specification but is not expected to affect its safety or effectiveness.
See 8 more

Exclusion Criteria

I am a sexually active male unwilling to use a condom.
It has been over 60 days since my first tisagenlecleucel infusion.
Pregnant or lactating women or women of child-bearing potential not using highly effective contraception
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to the initial tisagenlecleucel infusion

2-14 days

Initial Tisagenlecleucel Infusion

Participants receive the initial infusion of tisagenlecleucel

1 day

Early Reinfusion of Tisagenlecleucel

Participants receive a second infusion of tisagenlecleucel on day +30-60 after their initial infusion if meeting eligibility criteria

30-60 days post-initial infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of B-Cell Aplasia and toxicities

6 months

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness, including the evaluation of toxicities

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Tisagenlecleucel
Trial Overview The study tests whether an early second dose of tisagenlecleucel can maintain cancer remission at six months post-first infusion in patients with B-ALL. It also evaluates the safety and effectiveness of this reinfusion strategy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: TisagenlecleucelExperimental Treatment1 Intervention

Tisagenlecleucel is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Kymriah for:
🇪🇺
Approved in European Union as Kymriah for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Tisagenlecleucel (tisa-cel) is an effective CAR-T therapy for patients with relapsed/refractory follicular lymphoma (R/R FL), showing durable remissions even in high-risk patients, as confirmed by the pivotal ELARA study.
The therapy has a manageable toxicity profile, making it a viable option for patients who have undergone two lines of systemic therapies, leading to its FDA approval for this indication.
Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma.Saha, A., Jhaveri, K., Sarfraz, H., et al.[2023]
In a study of 79 pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia, those who responded to the CAR T-cell therapy tisagenlecleucel showed approximately double the expansion of the therapy in their blood compared to nonresponders, indicating a strong correlation between cellular expansion and treatment efficacy.
The therapy demonstrated persistence in responders for over two years, and its expansion continued even after treatment with tocilizumab, which is used to manage cytokine release syndrome, suggesting that tisagenlecleucel can remain effective despite potential side effects.
Clinical Pharmacology of Tisagenlecleucel in B-cell Acute Lymphoblastic Leukemia.Mueller, KT., Waldron, E., Grupp, SA., et al.[2020]
Tisagenlecleucel, a CAR-T cell therapy, shows high overall remission rates of 69% to 93% in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, with durable 12-month relapse-free survival rates of 55% to 59%.
However, the treatment is associated with significant risks, including potentially life-threatening cytokine release syndrome in 77% to 100% of patients and neurotoxicity in 31% to 45%, highlighting the need for careful patient selection and management.
Tisagenlecleucel in Acute Lymphoblastic Leukemia: A Review of the Literature and Practical Considerations.Halford, Z., Anderson, MK., Bennett, LL., et al.[2021]

Citations

Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma. [2023]
Clinical Pharmacology of Tisagenlecleucel in B-cell Acute Lymphoblastic Leukemia. [2020]
Tisagenlecleucel in Acute Lymphoblastic Leukemia: A Review of the Literature and Practical Considerations. [2021]
Impact of High Disease Burden on Survival in Pediatric Patients with B-ALL Treated with Tisagenlecleucel. [2023]
Estimation of Total Costs in Pediatric and Young Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia Receiving Tisagenlecleucel from a U.S. Hospital's Perspective. [2023]
Tisagenlecleucel in Children and Young Adults: Reverse Translational Research by Using Real-World Safety Data. [2020]
Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. [2021]
Efficacy and safety of tisagenlecleucel in Japanese pediatric and young adult patients with relapsed/refractory B cell acute lymphoblastic leukemia. [2022]
Characterization of the input material quality for the production of tisagenlecleucel by multiparameter flow cytometry and its relation to the clinical outcome. [2023]
Pooled safety analysis of tisagenlecleucel in children and young adults with B cell acute lymphoblastic leukemia. [2022]
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