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MT2017-45: CAR-T Cell Therapy for Heme Malignancies

StatusActive, Not Recruiting
PhasePhase 2
Started2018-12-18
View on ClinicalTrials.gov ↗

Amendment history

2026-01-06
Study Status, Outcome Measures, Outcome Measures (Results), Adverse Events v16
Results first postednot stated→2026-01-23
Primary endpoints2 entries, revised
Arm A & E: MRD-negative CR (or CRi)
2025-12-16
Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v15
Enrollment target144→150
Secondary endpoints9 to 8 entries
Arm A: MRD-negative CR (or CRi) Arm A: ProportionPercentage of patientsPatients whoDeveloping areGrade alive3 butor not4 inICANS Overall remission Toxicity
Primary endpoints3 to 2 entries
Arm A&G: CRiMRD-negative CR (completeor remission without count recoveryCRi) Arm A&G: Complete Remission (CR)
2025-03-28
Study Status, Study Design, Arms and Interventions, Eligibility v14
PhaseNot specified→Phase 2
2024-03-15
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2028-06-01→confirmed 2024-02-09
Enrollment targetestimated 240→confirmed 144
Study sitesdetails revised at 1 of 1 site
2023-03-15
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v12
Enrollment target120→240
Study arms4→7
InterventionsCyclophosphamide 250 mg/m2; 3 days (Drug), Cyclophosphamide 500 mg/m2; 2 doses (Drug), Cyclophosphamide 500 mg/m2; 3 doses (Drug)…→Abecma, Intravenous Suspension (Drug), Breyanzi Injectable Product (Drug), Cyclophosphamide 250 mg/m2; 3 days (Drug), Cyclophosphamide 500…
Eligibility criteria+6,015 characters
ARM A (Kymriah) and Arm G (Tecartus) : Kymriah for Refractory/relapsed B-cell acute lymphoblastic leukemia expr [...] sion Criteria: Age and Disease Status Must be age 0-25 years (for Arm A Kymriah) or >18 years (Arm G Tecartus) Disease status: Relapsed and refractory pediatric B-cell AL [...] er relapse or are considered refractory. Performance Status * Arm A: Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2 ALC >500/uL at screening (prior to apheresis) and absolute lymphocyte count >/= 150/uL Organ Function Renal function defined as: A serum [...] [...]
Secondary endpoints17 to 9 entries
Arm A: Treatment Related Mortality (TRM) Arm A: Treatment Related Mortality (TRM) Arm A: Treatment Related Mortality (TRM) Arm A: Relapse-free Survival (RFS) Arm A: Event-Free Survival (EFS) Arm A: Overall Survival (OS) Arm A: Toxicity Arms B/C/D: Complete Remission (CR) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Relapse-free Survival (RFS) Arms B/C: Event-free Survival (EFS) Arms B/C/D: Overall Survival (OS) Arms B/C/D: Tox [...]
Primary endpoints3 entries, revised
Arm A&G: CRi (complete remission without count recovery) Arm A&G: Complete Remission (CR) Arms B & C&D& E&F: Overall Response Rate (ORR)
Show 11 earlier versions
2023-03-07
Study Identification, Study Status v11
Re-verified, no change to tracked fields
2022-11-02
Study Status v10
Primary completion date2028-07→2028-06-01
Completion date2028-07→2028-06-01
2021-05-21
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
Study arms3→4
InterventionsCyclophosphamide (Drug), Cyclophosphamide (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Fludarabine (Drug), Fludarabine (Drug)…→Cyclophosphamide 250 mg/m2; 3 days (Drug), Cyclophosphamide 500 mg/m2; 2 doses (Drug), Cyclophosphamide 500 mg/m2; 3 doses (Drug)…
Eligibility criteria+3,043 characters
ARM A: Kymriah for Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19 Inclusion Criteria: Age and Disease Status Must be age 0-25 years Disease status [...] ULN OR eGFR ≥ 50 mL/min/1.73 m2 Liver function defined as: ** ALT ≤ 5 times the ULN for age (unless due to disease) ** Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gi [...] any research related tests or procedures. Exclusion Criteria: Pregnant or breastfeeding - Females of childbearing potenti [...] ta for Relapsed or Refractory diffuse large B cell lymphoma Inclusion Criteria: Age and Disease Status Adult patients (age ≥ 18 [...] [...]
Secondary endpoints17 entries, revised
Arms B/C/D: Complete Remission (CR) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Treatment Related Mortality (TRM) Arms B/C/D: Relapse-free Survival (RFS) Arms B/C/D: Overall Survival (OS) Arms B/C/D: Toxicity
Primary endpoints3 entries, revised
Arms B & C&D: Overall Response Rate (ORR)
Study sitescontacts updated at 1 of 1 site
2021-03-04
Study Status v8
Re-verified, no change to tracked fields
2020-02-13
Study Status, Eligibility v7
Eligibility criteria-748 characters
[...] o use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. Written voluntary consent (adults) or parental/guardian cons [...] he performance of any research related tests or procedures. See sections 4.4 and 4.5 for additional criteria involving pregnancy and contraception. Exclusion Criteria Pregnant or breastfeeding - Females of ch [...] odal lesions or extranodal lesion ECOG performance status 0-12 ALC >/=100/uL at screening (prior to apheresis) Renal funct [...] ly stable and LVEF ≥ 45% confirm [...]
2019-02-06
Study Status, Study Design, Arms and Interventions, Eligibility v6
PhasePhase 2→Not specified
2019-01-24
Study Identification, Study Status, Conditions v5
Study titlerevised
MT2017-45: :CAR-T Cell Therapy for Heme Malignancies
2019-01-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-12→confirmed 2018-12-18
Study sites0→1
2018-12-03
Study Status v3
Primary completion date2028-06→2028-07
Completion date2028-06→2028-07
Start date2018-11→2018-12
2018-09-25
2 amendments v1-v2
2 re-verifications since 2018-08-29, no change to tracked fields
2018-08-21
Original filing
This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.
Trial Details
NCT Number NCT03642626
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Enrollment 150 participants
Start Date 2018-12-18
Primary Completion 2024-02-09 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-23