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Acute Lymphoblastic LeukemiaPhase 2NCT03642626

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

A Phase 2 study testing KYMRIAH, YESCARTA and Fludarabine 30mg/m2 4 doses in people with Acute Lymphoblastic Leukemia and Large B-cell Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
KYMRIAH, YESCARTA and Fludarabine 30mg/m2 4 doses
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
18 Dec 2018to 1 Jun 2028
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 ALL defined by one of these:
  • Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or
  • Patients with persistent minimal residual disease (MRD >0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or
  • Patients in 2nd or greater relapse of B-ALL or
Show all 157Show fewer
  • Patients with persistent CNS leukemia, or
  • Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or
  • Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater 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
  • Organ Function
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
  • Other Inclusion Criteria
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
  • Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
  • Age and Disease Status
  • Adult patients (age ≥ 18 years)Patients must be ≥18 years of age
  • One of the following histologies and expression of CD19 by tumor cells:
  • diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
  • primary mediastinal large B-cell lymphoma, or
  • high grade B-cell lymphoma, or
  • DLBCL arising from follicular lymphoma
  • Disease status:
  • Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
  • Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
  • Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy
  • Measurable disease at time of apheresis: Nodal lesions or extranodal lesion
  • ECOG performance status 0-2
  • ALC >/=100/uL at screening (prior to apheresis)
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
  • Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
  • Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
  • Platelets ≥ 50.000/mm3 (transfusion support can be provided)
  • Hemoglobin >8.0 mg/dl (transfusion support can be provided)
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
  • Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
  • Age and Disease Status
  • Adult patients (age ≥ 18 years)
  • with relapsed or refractory (r/r) large B-cell lymphoma, including
  • diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
  • high grade B-cell lymphoma
  • and DLBCL arising from follicular lymphoma.
  • Disease status:
  • after two or more lines of systemic therapy or
  • relapse after autologous HCT
  • Performance Status
  • ECOG performance status 0-2
  • ALC >/=100/uL at screening (prior to apheresis)
  • Organ Function
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x ULN OR
  • eGFR ≥ 50 mL/min/1.73 m^2
  • 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
  • Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
  • Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
  • Platelets ≥ 50.000/mm3 (transfusion support can be provided)
  • Hemoglobin >8.0 mg/dl (transfusion support can be provided)
  • Other Inclusion Criteria
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
  • Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
  • Age and Disease Status
  • with relapsed or refractory (r/r) mantle cell lymphoma, including
  • prior anthracycline or Bendamustine containing therapy
  • prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb)
  • not a candidate or relapse after autologous HCT
  • active disease at enrollment
  • Performance Status
  • ECOG performance status 0-1
  • Organ Function
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
  • Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
  • Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
  • Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
  • Hemoglobin >8.0 mg/dl (transfusion support can be provided)
  • Other Inclusion Criteria:
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to 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 consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
  • Age and Disease Status
  • Adult patients (age ≥ 18 years)
  • with relapsed or refractory disease after two or more lines of systemic therapy, including
  • diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma),
  • high-grade B-cell lymphoma,
  • primary mediastinal large B-cell lymphoma,
  • follicular lymphoma grade 3B
  • Performance Status
  • ECOG performance status 0-2
  • Organ Function
  • Renal function defined as:
  • A serum creatinine of ≤1.5 x ULN OR
  • eGFR ≥ 30 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
  • Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
  • Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
  • Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
  • Hemoglobin >8.0 mg/dl (transfusion support can be provided)
  • Other Inclusion Criteria:
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to 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 consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
  • Age and Disease Status
  • Adult patients (age ≥ 18 years)
  • Relapsed (progression after prior partial or complete remission) or refractory multiple myeloma
  • Evidence of active disease (medullary or extramedullary)
  • Prior therapy (Failure or intolerance to) with an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody
  • Performance Status
  • ECOG performance status 0-1
  • Organ Function
  • Renal function defined as:
  • A serum creatinine of ≤2 x 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 Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
  • Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
  • Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
  • Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
  • Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
  • Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
  • Hemoglobin >8.0 mg/dl (transfusion support can be provided)
  • Other Inclusion Criteria:
  • Life expectancy ≥12 weeks
  • Women of child bearing potential and sexually active males with partners of child bearing potential must agree to 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 consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Who cannot join

  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
  • CNS 2A
  • CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
Show all 73Show fewer
  • Active HIV infection
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment.
  • Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1
  • ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma
  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
  • Active HIV infection (controlled HIV is permissible)
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
  • Patient has taken one of the prohibited concomitant medications within the timeframe.
  • ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma
  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
  • Active or inactive HIV infection
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
  • Patient has taken one of the prohibited concomitant medications within the timeframe
  • ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma
  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
  • Active HIV infection
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
  • Patient has taken one of the prohibited concomitant medications within the timeframe
  • ARM E: Breyanzi "lisocabtagene maraleucel" for relapsed or refractory large B-cell lymphoma
  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
  • Active HIV infection
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
  • Patient has taken one of the prohibited concomitant medications within the timeframe
  • ARM F: Abecma "Idecabtagene Vicleucel" for relapsed or refractory multiple myeloma
  • Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
  • Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
  • Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
  • Uncontrolled active hepatitis B or hepatitis C
  • Active HIV infection
  • Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
  • Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
  • Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
  • Intolerance to the excipients of the CAR-T cell product
  • Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
  • Patient has taken one of the prohibited concomitant medications within the timeframe

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies

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.

Being tested
KYMRIAH, YESCARTA, Fludarabine 30mg/m2 4 doses, Cyclophosphamide 500 mg/m2; 2 doses, Fludarabine 30mg/m2 3 doses
Keywords
ALL, CAR-T, CAR19-T, chimeric antigen receptor T cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KYMRIAHDrug

    Also called tisagenlecleucel

    FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells

  • YESCARTADrug

    CD19-directed genetically modified autologous T cell immunotherapy

  • Fludarabine 30mg/m2 4 dosesDrug

    30 mg/m2 IV daily for 4 doses

  • Cyclophosphamide 500 mg/m2; 2 dosesDrug

    500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine

  • Fludarabine 30mg/m2 3 dosesDrug

    30 mg/m2 IV daily for 3 doses

  • Cyclophosphamide 500 mg/m2; 3 dosesDrug

    500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine

  • Fludarabine 25mg/m2 3 daysDrug

    25 mg/m2 i.v. daily for 3 days

  • Cyclophosphamide 250 mg/m2; 3 daysDrug

    250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine

  • TecartusDrug

    Also called Brexucabtagene Autoleucel

    TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells

  • Abecma, Intravenous SuspensionDrug

    Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.

  • Cyclophosphamide 900 mg/m2; 1 dayDrug

    Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS

  • Breyanzi Injectable ProductDrug

    Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.

Study groups in NCT03642626
Study groupRoleWhat they receive
ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)ExperimentalNot described
Receives: Drug: KYMRIAH; Drug: Fludarabine 30mg/m2 4 doses; Drug: Cyclophosphamide 500 mg/m2; 2 doses
ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)ExperimentalNot described
Receives: Drug: YESCARTA; Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses
ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)ExperimentalNot described
Receives: Drug: KYMRIAH; Drug: Fludarabine 25mg/m2 3 days; Drug: Cyclophosphamide 250 mg/m2; 3 days
Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)ExperimentalNot described
Receives: Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Tecartus
Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)ExperimentalNot described
Receives: Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Breyanzi Injectable Product
Arm F: Abecma for relapsed or refractory multiple myelomaExperimentalNot described
Receives: Drug: Fludarabine 30mg/m2 3 doses; Drug: Cyclophosphamide 500 mg/m2; 3 doses; Drug: Abecma, Intravenous Suspension
Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)ExperimentalNot described
Receives: Drug: Fludarabine 25mg/m2 3 days; Drug: Tecartus; Drug: Cyclophosphamide 900 mg/m2; 1 day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arms B & C&D& E&F: Overall Response Rate (ORR)

    ORR defined by complete response + partial response by Lugano

    Measured: Day 100

  2. Arm A & E: MRD-negative CR (or CRi)

    Percentage of patients with MRD-negative Complete Response CR (or CRi)

    Measured: Day 28

Secondary outcomes (8)

  1. Percentage of Patients Developing Grade 3 or 4 ICANS

    Percentage of patients developing grade 3 or 4 ICANS

    Measured: Day 28

  2. Treatment Related Mortality (TRM)

    Incidence of treatment related mortality (in absence of disease relapse/progression)

    Measured: Day 28

  3. Treatment Related Mortality (TRM)

    Incidence of treatment related mortality (in absence of disease relapse/progression)

    Measured: Day 100

  4. Treatment Related Mortality (TRM)

    Incidence of treatment related mortality (in absence of disease relapse/progression)

    Measured: 1 Year

  5. Relapse-free Survival (RFS)

    Incidence of Relapse-free Survival (RFS)

    Measured: 1 year

  6. Event-Free Survival (EFS)

    Incidence of event-free survival (EFS) from the date of the CAR-T infusion through 1 year post treatment

    Measured: 1 Year post treatment

  7. Overall Survival (OS)

    Incidence of Overall Survival (OS) from the date of the CAR-T infusion through the date of patient death for any reason.

    Measured: 1 year

  8. Overall Toxicity

    Percentage of patients with grade 3 or 4 targeted toxicity of CRS and/or neurotoxicity

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start18 Dec 2018
  3. Primary completion9 Feb 2024
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642626
Sponsor's protocol ID
2017LS118
Other IDs
MT2017-45, NCI-2020-04527
Status last verified
Jan 2026
First submitted
21 Aug 2018
Last updated
23 Jan 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KYMRIAH, YESCARTA and Fludarabine 30mg/m2 4 doses in people with Acute Lymphoblastic Leukemia and Large B-cell Lymphoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 157 inclusion and 73 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arms B & C&D& E&F: Overall Response Rate (ORR) (time frame: Day 100). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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