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NCT05541341

Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion moved earlier from Nov 23, 2043 to Nov 23, 2037 Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Start date: Nov 23, 2023 to Nov 24, 2023
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 2 words
  2. Primary and study completion dates: Dec 16, 2038 to Nov 23, 2043
    • Study sites: 6 to 7
    • Start date: Nov 24, 2023 to Nov 23, 2023
    v11
  3. Study sites: 5 to 6v10
  4. Study sites: 4 to 5v9
  5. Study sites: 1 to 4v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 27, 2023 to Nov 24, 2023
    v7
  2. Primary and study completion dates: Dec 16, 2037 to Dec 16, 2038v6 Show 4 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Study description shortened, about 16 words
    • Study title shortened, about 6 words
    • Study arms: 2 to 3
  3. Start date: Jul 31, 2023 to Oct 27, 2023v5
  4. Start date: May 31, 2023 to Jul 31, 2023
    • Eligibility criteria expanded, about 1 word
    v4
  5. Start date: Mar 15, 2023 to May 31, 2023v3
  6. Start date: Dec 16, 2022 to Mar 15, 2023v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall response rate (ORR)
Timeframe: Up to 15 years
MRD negative overall response rate
Timeframe: Up to 15 years
Duration of overall response (DOR)
Timeframe: Up to 15 years
Relapse-free survival (RFS)
Timeframe: Up to 15 years
Event-free survival (EFS) for ALL patients
Timeframe: Up to 15 years
Progression free survival (PFS) for DLBCL patients
Timeframe: Up to 15 years
Overall survival (OS)
Timeframe: Up to 15 years
Number of ALL patients with hematologic recovery
Timeframe: Up to 15 years

Secondary (4)

The type and frequency of SAEs and AE of special interest
Incidence and severity of CRS and ICANS among HTLV 1 and 2 positive versus HTLV 1 and 2 negative patients
Pregnancy rates
Number of patients with confirmed secondary malignancies diagnosis

Arms and interventions

Acute Lymphoblastic Leukemia (ALL)

Children/young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia who received tisagenlecleucel infusion

Diffuse Large B-cell Lymphoma (DLBCL)

Adult patients with relapsed/refractory Diffuse Large B-cell Lymphoma who received tisagenlecleucel infusion

Follicular Lymphoma (FL)

Patients of any gender aged 18 year or older, with relapsed/refractory Follicular Lymphoma who received tisagenlecleucel infusion.

Other: tisagenlecleucel

Sites

7 sites in 1 country