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New treatment option for B Acute Lymphoblastic Leukemia
Official title Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
ClinicalTrials.gov ID: NCT05310591
What this study is testing
What is Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) )?
Decreasing starting times for beginning nivolumab (Time to Event Continual Reassessment Method (TITE-CRM) ) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Tisagenlecleucel (CTL019) is an anti-CD19 autologous Chimeric Antigen Receptor (CAR) T-cell therapy, which has shown dramatic early results in advanced ALLs. Early loss of B-cell aplasia (recovery of B-cells in marrow/ peripheral blood within 6 months after infusion), a marker of the loss or non-functionality of the CAR T-cells, is associated to a very high risk of relapse.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd...
- Patient must have a second tisagenlecleucel (Kymriah ®) product available
- Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes \< 10...
- Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes \< 10 /mm3 and/ or...
- Life expectancy \> 12 weeks.
You likely can't join if
- Patient has received intervening therapy for leukemia after first tisagenlecleucel infusion (chemotherapy, anti leukemic immunotherapy, ITK...
- Patient has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Patient has known history of, or any evidence of active, non-infectious pneumonitis.
- Patient has a history of non-infectious pneumonitis that required steroid or has current pneumonitis.
- Had receive prior therapy with an anti-PD1, Anti- PDL1 or anti-PDL2 agent.
- Patient has hypersensivity to pembrolizumab/ nivolumab or one of its excipients
See the full eligibility criteria
- Patients aged from 1 to 25 years (pediatric and young adults) with a history of CD19+ relapsed or refractory B-ALL (any relapse after HSCT, 2nd relapse or later, refractory ALL).
- Patient must have a second tisagenlecleucel (Kymriah ®) product available
- Cohort 1: previously treated by tisagenlecleucel (Kymriah ®), and who present an early loss of B-cell aplasia defined by blood B lymphocytes \< 10 /mm3 and/ or \< 3% of total lymphocytes (\< 6 months after infusion)...
- Cohort 2: previously treated by tisagenlecleucel (Kymriah ®), who present a loss of B-cell aplasia defined by blood B lymphocytes \< 10 /mm3 and/ or \< 3% of total lymphocytes and a CD19+ ALL detectable disease in the...
- Life expectancy \> 12 weeks.
- Karnofsky (age \> 16) Lansky (age \ 70 at screening.
- No organ dysfunction
- Who have signed an informed consent
- Affiliation to social security or any health insurance (as a beneficiary or assignee)
- Patient has received intervening therapy for leukemia after first tisagenlecleucel infusion (chemotherapy, anti leukemic immunotherapy, ITK, allogeneic HSCT).
- Patient has an active autoimmune disease requiring systemic treatment within the past 2 years.
- Patient has known history of, or any evidence of active, non-infectious pneumonitis.
- Patient has a history of non-infectious pneumonitis that required steroid or has current pneumonitis.
- Had receive prior therapy with an anti-PD1, Anti- PDL1 or anti-PDL2 agent.
- Patient has hypersensivity to pembrolizumab/ nivolumab or one of its excipients
- Patient has received a live vaccine injection within 45 days of planned start of study therapy.
- Patients with concomitant genetic syndromes associated with bone marrow failure states: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome...
- Patients with Burkitt's lymphoma/leukemia
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- Prior treatment with any gene therapy product except first tisagenlecleucel (Kymriah ®) injection.
- Prior treatment with any anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy, except for patients pre-treated with blinatumomab and/or tisagenlecleucel (Kymriah®)
- Prior anti-cancer monoclonal antibody within 4 weeks before starting the study.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade1 or at baseline) from adverse events due to a previously administered...
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of Screening), or any uncontrolled infection at Screening.
- Human immunodeficiency virus (HIV) positive test within 8 weeks of Screening.
- Presence of grade 2 to 4 acute or extensive chronic GVHD.
- Active CNS involvement by malignancy, defined as CNS-3 per NCCN guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible.
- Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening.
- Previous or concurrent malignancy with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma
- in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study.
- A primary malignancy completely resected and in CR for ≥ 5 years
- Pregnant or lactating women (female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion)
- Patient with hypersensivity to Fludarabine and/or cyclophosphamide and/or tisagenlecleucel and/or nivolumab or one of their excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lille, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Paris, France
- Rouen, France
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lille, France; Lyon, France; Marseille, France; Montpellier, France; Nancy, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.