Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT04546399

Rekrutiert

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Interventionsstudie

Phase 2

Newark Beth Israel Medical Center

Sponsor: National Cancer Institute (NCI)

Zuletzt aktualisiert: 10. September 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Eingriff, Andere Medikamente, Checkpoint-Inhibitoren, Chemotherapie, Monoklonaler Antikörper, Strahlentherapie

Erforderliche Mutationen

CD19

Studie gestartet

17. Dezember 2020

Zuletzt vom Sponsor aktualisiert

10. September 2025

Voraussichtlicher Abschluss

30. Juni 2028

Studienkontakt

Eignung

Einschlusskriterien

* Patients must be >= 1 and < 31 years at time of enrollment

* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:

* Isolated bone marrow relapse

* Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse

* Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes

* Patients with Down syndrome (DS) are eligible in the following categories:

* Isolated bone marrow relapse

* Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse

* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

* Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay

* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

* Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression

* Patients must not have had a prior hematopoietic stem cell transplant

* A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted

* In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible

* Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) >= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required

* Patients with Down syndrome who received pre-enrollment therapy and have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy

* Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy

* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment):

* Age: Maximum serum creatinine (mg/dL)

* 1 to < 2 years: 0.6 (male), 0.6 (female)

* 2 to < 6 years: 0.8 (male), 0.8 (female)

* 6 to < 10 years: 1 (male), 1 (female)

* 10 to < 13 years: 1.2 (male), 1.2 (female)

* 13 to < 16 years: 1.5 (male), 1.4 (female)

* >= 16 years: 1.7 (male), 1.4 (female)

* The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)

* Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram

* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination

* All patients and/or their parents or legal guardians must sign a written informed consent

* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Ausschlusskriterien

* Patients with B-lymphoblastic lymphoma (B-LLy)

* Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia

* Patients with Philadelphia chromosome positive (Ph+) B-ALL

* Patients with mixed phenotype acute leukemia (MPAL)

* Patients with known Charcot-Marie-Tooth disease

* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype

* Patients with active, uncontrolled infection defined as:

* Positive bacterial blood culture within 48 hours of study enrollment

* Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.

* Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for > 48 hours

* A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection

* Active viral or protozoal infection requiring IV treatment

* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.

* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible

* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement

* Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved

* Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll

* Group 4 and patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible

* Note: Group 3 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease

* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab

* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer461

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: See Outline section

Interventionen:

Bone Marrow Aspiration
Bone Marrow Biopsy
Mercaptopurine
Lumbar Puncture
Calaspargase Pegol
Nivolumab
Cytarabine
Blinatumomab
Dexamethasone
3-Dimensional Conformal Radiation Therapy
Hydrocortisone Sodium Succinate
Pegaspargase
Biospecimen Collection
Methotrexate
Pegcrisantaspase
Vincristine Sulfate

Ergebnismessungen

Primäre Ergebnismessungen

Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1)Up to 2 cycles of therapy (each cycle = 36 days)

MRD negative Rem-2 be defined as Rem-2 (i.e., achievement of MRD < 1% blasts by flow cytometry and resolution of extramedullary disease (for CNS disease, requires CNS 1) ) and bone marrow with MRD < 0.01% by flow cytometry. MRD negative Rem-2 rate between Arm A vs Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.10. Interim analysis will be conducted to monitor for futility. The futility boundaries are based on testing the alternative hypothesis at the 0.067 level.

Event-free survival post-reinduction (EFS PR) (Group 3)From date of randomization to date of treatment failure, relapse, disease progression, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment.

Comparison of EFS post reinduction between Arm E versus Arm F will be based on a one-sided two-sample logrank test with Type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. Interim analysis will be conducted to monitor for futility. The futility monitoring will be based on testing the alternative hypothesis at the 0.067 level. This alpha level corresponds to that which would cause futility stopping if the one-sided two-sample logrank test shows evidence of a hazard ratio > 1.0 when half of the expected events are observed.

EFS PR (Group 4)From date of randomization to date of treatment failure, relapse, disease progression, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment.

Comparison of EFS post reinduction between Arm H versus Arm I will be based on a one-sided two-sample logrank test with Type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. Interim analysis will be conducted to monitor for futility. The futility monitoring will be based on testing the alternative hypothesis at the 0.067 level. This alpha level corresponds to that which would cause futility stopping if the one-sided two-sample logrank test shows evidence of a hazard ratio > 1.0 when half of the expected events are observed.

Sekundäre Ergebnismessungen

Dose-limiting toxicityUp to 1 cycle of therapy (each cycle = 36 days)

Will be assessed using the Common Terminology Criteria for Adverse Events version 5.0.

EFS PR (Group 4)From date of randomization to date of treatment failure, relapse, disease progression, SMN or death due to any cause, assessed up to 5 years after completion of enrollment

Comparison of EFS post-reinduction between Arm C versus Arm D will be based on a one-sided two-sample logrank test with type I error of 0.15, to be conducted 2 years after completion of enrollment of Group 2. The futility monitoring will be based on testing the alternative hypothesis at the 0.092 level.

Event-free survival (Group 1)From date of Group 1 randomization to date of treatment failure, relapse, disease progression, SMN or death due to any cause, assessed up to 5 years

EFS will be compared between Arm A and Arm B, and to similar patients treated on AALL1331. These analyses will be performed using logrank tests, semi-parametric or parametric survival analysis methods, as appropriate.

Event free survival (Group 4)From date of Group 4 randomization to date of treatment failure, relapse, disease progression, SMN or death due to any cause, assessed up to 5 years

EFS will be compared between Arm H and Arm I, and to similar patients treated on AALL1331. These analyses will be performed using logrank tests, semi-parametric or parametric survival analysis methods, as appropriate.

Incidence of adverse events in Arm A or Arm BUp to 1 cycle of therapy (each cycle = 36 days)

The toxicities as defined by grade 3 or greater reported adverse events during the first cycle of blinatumomab or blinatumomab/nivolumab will be compared to similar patients treated with Block 1 of cytotoxic chemotherapy on AALL1331 using two-sample test of proportions.

Incidence of adverse events in Arm H or Arm IUp to 1 cycle of therapy (each cycle = 36 days)

MRD negative Rem-2 rate (Group 2)Up to 2 cycles of therapy (each cycle = 36 days)

MRD negative Rem-2 rate will be estimated and be compared between Arm C and Arm D using two-sample test of proportions.

Dose-limiting toxicity (Down syndrome patients)Up to 1 cycle of therapy (each cycle = 36 days)

Analyses will be largely descriptive.

Incidence of adverse events (Down syndrome patients)Up to 1 cycle of therapy (each cycle = 36 days)

Analyses will be largely descriptive.

MRD negative Rem-2 rate (Down syndrome patients)Up to 2 cycles of therapy (each cycle = 36 days)

Analyses will be largely descriptive.

Subset analyses of EFSUp to 2 cycles of therapy (each cycle = 36 days)

Features at first relapse including degree of marrow disease at relapse, age, sex, body mass index, cytogenetics, site(s) of relapse, percent peripheral blasts at relapse and absolute lymphocyte count, will be conducted. These analyses will be exploratory.

Subset analyses of OSUp to 2 cycles of therapy (each cycle = 36 days)

EFS PR (Group 4)At 2 years from date of randomization

Corresponding 95% CIs by sex, by race, and by ethnicity separately for arm H and I.

EFS PR (Group 3)At 3 years from date of randomization

Corresponding 95% CIs by sex, by race, and by ethnicity separately for arm E and F.

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Studienzentren

Diese Studie hat 146 Studienzentren

Newark Beth Israel Medical Center

Newark, New Jersey, US

Name:Site Public Contact

E-Mail:Christine.Kosmides@rwjbh.org

Telefon:973-926-7230

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Newark, New Jersey, 07112 US

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Children's National Medical Center

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Québec, G1V 4G2 CA

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

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St Louis, Missouri, 63104 US

Cardinal Glennon Children's Medical Center

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