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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Study of Out of Specification for Tisagenlecleucel
ClinicalTrials.gov ID: NCT04094311
What this study is testing
What is CTL019?
CTL019 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Also referred to as Tisagenlecleucel.
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
- This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 100
You may be able to join if
- Signed informed consent/assent must be obtained for this study prior to participation in the study.
- Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
- Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective...
- OOS material has not been deemed to pose an undue safety risk to the patient.
- Patient is suffering from a serious or life-threatening disease or condition.
You likely can't join if
- For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:
- Human immunodeficience virus (HIV) positive patients.
- Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- Patients with primary central nervous system (CNS) lymphoma.
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
- Uncontrolled active infection or inflammation.
See the full eligibility criteria
- Signed informed consent/assent must be obtained for this study prior to participation in the study.
- Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
- Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
- OOS material has not been deemed to pose an undue safety risk to the patient.
- Patient is suffering from a serious or life-threatening disease or condition.
- Repeat leukapheresis is not clinically appropriate per the investigator assessment. Key
- For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:
- Human immunodeficience virus (HIV) positive patients.
- Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- Patients with primary central nervous system (CNS) lymphoma.
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
- Uncontrolled active infection or inflammation.
- Any medical condition identified by the investigator that may impact the assessment of the safety or how well it works outcomes in relation to study treatment.
- Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Nagoya, Aichi-ken, Japan
- Tōon, Ehime, Japan
- Gifu, Gifu, Japan
- Sapporo, Hokkaido, Japan
- Kobe, Hyōgo, Japan
- Nishinomiya, Hyōgo, Japan
- Tsukuba, Ibaraki, Japan
- Kita-gun, Kagawa-ken, Japan
- Yokohama, Kanagawa, Japan
- Kumamoto, Kumamoto, Japan
- Kyoto, Kyoto, Japan
- Tsu, Mie-ken, Japan
- Sendai, Miyagi, Japan
- Matsumoto, Nagano, Japan
- Nagasaki, Nagasaki, Japan
+ 27 more site(s).
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, 0 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Nagoya, Aichi-ken, Japan and 41 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.