Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT ID: NCT06918431
Last Updated: 2025-10-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
53 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-10
Study Completion Date
2029-03-30
Brief Summary
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This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi, and is used with other drugs in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. It is a type of anthracycline antibiotic and a type of topoisomerase inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving asparaginase Erwinia chrysanthemi with induction chemotherapy followed by consolidation chemotherapy may be safe, tolerable, and/or effective in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma.
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Detailed Description
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PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of asparaginase Erwinia chrysanthemi (asparaginase Erwinia chrysanthemi-recombinant-rywn \[recombinant Erwinia asparaginase\]; 25 mg/m\^2 every 48 hours \[hrs\]) as first asparaginase during induction therapy through the assessment of type, frequency, severity, attribution, time course and duration of adverse events. (Safety Lead-in) II. To evaluate the proportion of patients with grade 3 or higher (G3+) hepatotoxicity that are at least possibly related to the study drug (recombinant Erwinia asparaginase) and not resolved to grade 1 or lower within 14 days of occurrence in the target patient population during induction. (Expansion)
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of recombinant Erwinia asparaginase (25 mg/m\^2 every 48 hrs) as first asparaginase during induction therapy through the assessment of type, frequency, severity, attribution, and duration of adverse events (expansion cohort).
II. To evaluate composite complete remission (CR or CR with incomplete hematologic recovery \[CRi\]) rate after induction ± extended induction.
III. To evaluate CR rate after induction ± extended induction. IV. To evaluate minimal residual disease (MRD) negativity rate after induction ± extended induction.
V. To evaluate number of patients able to receive extended induction or post induction consolidation or salvage therapy within 42 days from initiating induction.
VI. To evaluate MRD negativity rate after consolidation for patients receiving the study drug.
VII. To evaluate the proportion of patients with G3+ hepatotoxicity that are at least possibly related to the study drug during induction.
VIII. To evaluate the proportion of patients maintaining adequate 48 hour nadir serum asparaginase activity (NSAA ≥ 0.1 IU/mL) post recombinant Erwinia asparaginase during induction +/- extended induction.
IX. To evaluate the duration of G3+ hepatotoxicity.
EXPLORATORY OBJECTIVES:
I. To evaluate the safety and tolerability of recombinant Erwinia asparaginase (at approved dosing) as first asparaginase during extended induction and consolidation therapy through the assessment of type, frequency, severity, attribution, time course and duration of adverse events.
II. To evaluate the proportion of patients maintaining adequate, either at 48 hours or 72 hrs, nadir serum asparaginase activity (NSAA ≥ 0.1 IU/mL) post recombinant Erwinia asparaginase during consolidation.
III. To evaluate the molecular profile by next-generation sequencing (NGS) and its association with MRD- response to recombinant Erwinia asparaginase based induction.
OUTLINE:
INDUCTION (CYCLE 1): Patients receive cytarabine intrathecally (IT) on day 1, dexamethasone orally (PO) twice daily (BID) on days 1-7 and 15-21, vincristine intravenously (IV) on days 1, 8, 15, and 22, daunorubicin IV over 5-30 minutes on days 1, 8, 15, and 22, asparaginase Erwinia chrysanthemi intramuscularly (IM) on days 4, 6, 8, 10, 12, 14, and 16, and methotrexate IT on days 8 and 29. Patients with CNS3 disease also receive methotrexate IT on days 15 and 22. CD20 positive patients also receive rituximab IV on day 8. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with M2 marrow (\> 5% lymphoblasts) on day 29 proceed to Extended Induction Cycle 1A. All other patients proceed to Consolidation Cycle 2.
EXTENDED INDUCTION (CYCLE 1A): Patients receive dexamethasone PO BID on days 1-7, vincristine IV on days 1 and 8, daunorubicin IV over 5-30 minutes on day 1, and asparaginase Erwinia chrysanthemi IM on days 4, 6, 8, 10, 12, 14, and 16 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION (CYCLE 2): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50, and methotrexate IT on days 1, 8, 15 and 22 (NOTE: Patients with CNS3 disease omit methotrexate on days 15 and 22). CD20 positive patients also receive rituximab IV on days 1 and 20. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit may also receive asparaginase Erwinia chrysanthemi IM every other day on days 15, 17, 19, 21, 23, 25, 27, 43, 45, 47, 49, 51, 53, and 55 or every Monday/Wednesday/Friday (if days 15 and 43 are Mondays) on days 15, 17, 19, 22, 24, 26, 43, 45, 47, 50, 52, and 54 at discretion of treating physician. Patients may receive 2 courses of every other day or Monday/Wednesday/Friday treatment in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo echocardiography at screening and blood sample collection, bone marrow aspiration and/or biopsy, lumbar puncture, and computed tomography (CT) and/or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed up at 30 days.
I. To evaluate the safety and tolerability of asparaginase Erwinia chrysanthemi (asparaginase Erwinia chrysanthemi-recombinant-rywn \[recombinant Erwinia asparaginase\]; 25 mg/m\^2 every 48 hours \[hrs\]) as first asparaginase during induction therapy through the assessment of type, frequency, severity, attribution, time course and duration of adverse events. (Safety Lead-in) II. To evaluate the proportion of patients with grade 3 or higher (G3+) hepatotoxicity that are at least possibly related to the study drug (recombinant Erwinia asparaginase) and not resolved to grade 1 or lower within 14 days of occurrence in the target patient population during induction. (Expansion)
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of recombinant Erwinia asparaginase (25 mg/m\^2 every 48 hrs) as first asparaginase during induction therapy through the assessment of type, frequency, severity, attribution, and duration of adverse events (expansion cohort).
II. To evaluate composite complete remission (CR or CR with incomplete hematologic recovery \[CRi\]) rate after induction ± extended induction.
III. To evaluate CR rate after induction ± extended induction. IV. To evaluate minimal residual disease (MRD) negativity rate after induction ± extended induction.
V. To evaluate number of patients able to receive extended induction or post induction consolidation or salvage therapy within 42 days from initiating induction.
VI. To evaluate MRD negativity rate after consolidation for patients receiving the study drug.
VII. To evaluate the proportion of patients with G3+ hepatotoxicity that are at least possibly related to the study drug during induction.
VIII. To evaluate the proportion of patients maintaining adequate 48 hour nadir serum asparaginase activity (NSAA ≥ 0.1 IU/mL) post recombinant Erwinia asparaginase during induction +/- extended induction.
IX. To evaluate the duration of G3+ hepatotoxicity.
EXPLORATORY OBJECTIVES:
I. To evaluate the safety and tolerability of recombinant Erwinia asparaginase (at approved dosing) as first asparaginase during extended induction and consolidation therapy through the assessment of type, frequency, severity, attribution, time course and duration of adverse events.
II. To evaluate the proportion of patients maintaining adequate, either at 48 hours or 72 hrs, nadir serum asparaginase activity (NSAA ≥ 0.1 IU/mL) post recombinant Erwinia asparaginase during consolidation.
III. To evaluate the molecular profile by next-generation sequencing (NGS) and its association with MRD- response to recombinant Erwinia asparaginase based induction.
OUTLINE:
INDUCTION (CYCLE 1): Patients receive cytarabine intrathecally (IT) on day 1, dexamethasone orally (PO) twice daily (BID) on days 1-7 and 15-21, vincristine intravenously (IV) on days 1, 8, 15, and 22, daunorubicin IV over 5-30 minutes on days 1, 8, 15, and 22, asparaginase Erwinia chrysanthemi intramuscularly (IM) on days 4, 6, 8, 10, 12, 14, and 16, and methotrexate IT on days 8 and 29. Patients with CNS3 disease also receive methotrexate IT on days 15 and 22. CD20 positive patients also receive rituximab IV on day 8. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with M2 marrow (\> 5% lymphoblasts) on day 29 proceed to Extended Induction Cycle 1A. All other patients proceed to Consolidation Cycle 2.
EXTENDED INDUCTION (CYCLE 1A): Patients receive dexamethasone PO BID on days 1-7, vincristine IV on days 1 and 8, daunorubicin IV over 5-30 minutes on day 1, and asparaginase Erwinia chrysanthemi IM on days 4, 6, 8, 10, 12, 14, and 16 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION (CYCLE 2): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50, and methotrexate IT on days 1, 8, 15 and 22 (NOTE: Patients with CNS3 disease omit methotrexate on days 15 and 22). CD20 positive patients also receive rituximab IV on days 1 and 20. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit may also receive asparaginase Erwinia chrysanthemi IM every other day on days 15, 17, 19, 21, 23, 25, 27, 43, 45, 47, 49, 51, 53, and 55 or every Monday/Wednesday/Friday (if days 15 and 43 are Mondays) on days 15, 17, 19, 22, 24, 26, 43, 45, 47, 50, 52, and 54 at discretion of treating physician. Patients may receive 2 courses of every other day or Monday/Wednesday/Friday treatment in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo echocardiography at screening and blood sample collection, bone marrow aspiration and/or biopsy, lumbar puncture, and computed tomography (CT) and/or positron emission tomography (PET)/CT throughout the study.
After completion of study treatment, patients are followed up at 30 days.
Conditions
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B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Lymphoblastic Lymphoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment (asparaginase Erwinia chrysanthemi)
See Detailed Description
Group Type
EXPERIMENTAL
Asparaginase Erwinia chrysanthemi
Intervention Type
DRUG
Given IM
Biospecimen Collection
Intervention Type
PROCEDURE
Undergo blood sample collection
Bone Marrow Aspiration
Intervention Type
PROCEDURE
Undergo bone marrow aspiration and/or biopsy
Bone Marrow Biopsy
Intervention Type
PROCEDURE
Undergo bone marrow aspiration and/or biopsy
Computed Tomography
Intervention Type
PROCEDURE
Undergo CT or PET/CT
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IT
Cytarabine
Intervention Type
DRUG
Given IV or SC
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given PO
Echocardiography
Intervention Type
PROCEDURE
Undergo echocardiography
Lumbar Puncture
Intervention Type
PROCEDURE
Undergo lumbar puncture
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IT
Positron Emission Tomography
Intervention Type
PROCEDURE
Undergo PET/CT
Rituximab
Intervention Type
BIOLOGICAL
Given IV
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Interventions
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Asparaginase Erwinia chrysanthemi
Given IM
Intervention Type
DRUG
Biospecimen Collection
Undergo blood sample collection
Intervention Type
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration and/or biopsy
Intervention Type
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow aspiration and/or biopsy
Intervention Type
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
Intervention Type
PROCEDURE
Cyclophosphamide
Given IV
Intervention Type
DRUG
Cytarabine
Given IT
Intervention Type
DRUG
Cytarabine
Given IV or SC
Intervention Type
DRUG
Daunorubicin Hydrochloride
Given IV
Intervention Type
DRUG
Dexamethasone
Given PO
Intervention Type
DRUG
Echocardiography
Undergo echocardiography
Intervention Type
PROCEDURE
Lumbar Puncture
Undergo lumbar puncture
Intervention Type
PROCEDURE
Mercaptopurine
Given PO
Intervention Type
DRUG
Methotrexate
Given IT
Intervention Type
DRUG
Positron Emission Tomography
Undergo PET/CT
Intervention Type
PROCEDURE
Rituximab
Given IV
Intervention Type
BIOLOGICAL
Vincristine Sulfate
Given IV
Intervention Type
DRUG
Other Intervention Names
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Asparaginase Erwinia chrysanthemi (Recombinant)-rywn
Asparaginase Erwinia chrysanthemi, Recombinant-rywn
Asparaginase Erwinia chrysanthemi-rywn
Crisantaspase
Crisantaspase Biobetter JZP-458
Crisantaspasum
Enrylaze
Erwinase
Erwinaze
JZP 458
JZP-458
JZP458
PF743
RC-P JZP-458
Recombinant Asparaginase erwinia chrysanthemi JZP-458
Recombinant Crisantaspase JZP-458
Recombinant Erwinia asparaginase JZP-458
Rylaze
Biological Sample Collection
Biospecimen Collected
Specimen Collection
Biopsy of Bone Marrow
Biopsy, Bone Marrow
CAT
CAT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized axial tomography (procedure)
Computerized Tomography
Computerized Tomography (CT) scan
CT
CT Scan
tomography
(-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Asta B 518
B 518
B-518
B518
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
CP monohydrate
CTX
CYCLO-cell
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR 138719
WR- 138719
WR-138719
WR138719
.beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Alexan
Ara-C
ARA-cell
Arabine
Arabinofuranosylcytosine
Arabinosylcytosine
Aracytidine
Aracytin
Aracytine
Beta-Cytosine Arabinoside
CHX-3311
Cytarabinum
Cytarbel
Cytosar
Cytosine Arabinoside
Cytosine-.beta.-arabinoside
Cytosine-beta-arabinoside
Erpalfa
Starasid
Tarabine PFS
U 19920
U-19920
Udicil
WR-28453
.beta.-Cytosine arabinoside
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-.beta.-D-Arabinofuranosylcytosine
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
1-Beta-D-arabinofuranosylcytosine
1.beta.-D-Arabinofuranosylcytosine
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Alexan
Ara-C
ARA-cell
Arabine
Arabinofuranosylcytosine
Arabinosylcytosine
Aracytidine
Aracytin
Aracytine
Beta-Cytosine Arabinoside
CHX-3311
Cytarabinum
Cytarbel
Cytosar
Cytosine Arabinoside
Cytosine-.beta.-arabinoside
Cytosine-beta-arabinoside
Erpalfa
Starasid
Tarabine PFS
U 19920
U-19920
Udicil
WR-28453
Cerubidin
Cerubidine
Cloridrato de Daunorubicina
Daunoblastin
Daunoblastina
Daunoblastine
Daunomycin Hydrochloride
Daunomycin, hydrochloride
Daunorubicin.HCl
Daunorubicini Hydrochloridum
FI-6339
Ondena
RP-13057
Rubidomycin Hydrochloride
Rubilem
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron
Decadron DP
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasone Intensol
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Dxevo
Fluorodelta
Fortecortin
Gammacorten
Hemady
Hexadecadrol
Hexadrol
LenaDex
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
TaperDex
Visumetazone
ZoDex
EC
LP
Spinal Tap
3H-Purine-6-thiol
6 MP
6 Thiohypoxanthine
6 Thiopurine
6-Mercaptopurine
6-Mercaptopurine Monohydrate
6-MP
6-Purinethiol
6-Thiopurine
6-Thioxopurine
6H-Purine-6-thione, 1,7-dihydro- (9CI)
7-Mercapto-1,3,4,6-tetrazaindene
Alti-Mercaptopurine
Azathiopurine
Bw 57-323H
Flocofil
Ismipur
Leukerin
Leupurin
Mercaleukim
Mercaleukin
Mercaptina
Mercaptopurinum
Mercapurin
Mern
NCI-C04886
Puri-Nethol
Purimethol
Purine, 6-mercapto-
Purine-6-thiol (8CI)
Purine-6-thiol, monohydrate
Purinethiol
Purinethol
U-4748
WR-2785
Abitrexate
Alpha-Methopterin
Amethopterin
Brimexate
CL 14377
CL-14377
Emtexate
Emthexat
Emthexate
Farmitrexat
Fauldexato
Folex
Folex PFS
Jylamvo
Lantarel
Ledertrexate
Lumexon
Maxtrex
Medsatrexate
Metex
Methoblastin
Methotrexate LPF
Methotrexate Methylaminopterin
Methotrexatum
Metotrexato
Metrotex
Mexate
Mexate-AQ
MTX
Novatrex
Rheumatrex
Texate
Tremetex
Trexeron
Trixilem
WR-19039
Medical Imaging, Positron Emission Tomography
PET
PET Scan
Positron emission tomography (procedure)
Positron Emission Tomography Scan
Positron-Emission Tomography
PT
ABP 798
ABP-798
ABP798
BI 695500
BI-695500
BI695500
Blitzima
C2B8 Monoclonal Antibody
Chimeric Anti-CD20 Antibody
CT P10
CT-P10
CTP10
GP 2013
GP-2013
GP2013
IDEC 102
IDEC-102
IDEC-C2B8
IDEC-C2B8 Monoclonal Antibody
IDEC102
Ikgdar
Mabtas
MabThera
Monoclonal Antibody IDEC-C2B8
PF 05280586
PF-05280586
PF05280586
Riabni
Ritemvia
Rituxan
Rituximab ABBS
Rituximab ARRX
Rituximab Biosimilar ABP 798
Rituximab Biosimilar BI 695500
Rituximab Biosimilar CT-P10
Rituximab Biosimilar GB241
Rituximab Biosimilar GP2013
Rituximab Biosimilar IBI301
Rituximab Biosimilar JHL1101
Rituximab Biosimilar PF-05280586
Rituximab Biosimilar RTXM83
Rituximab Biosimilar SAIT101
Rituximab Biosimilar SIBP-02
rituximab biosimilar TQB2303
Rituximab PVVR
Rituximab-abbs
Rituximab-arrx
Rituximab-blit
Rituximab-pvvr
Rituximab-rite
Rituximab-rixa
Rituximab-rixi
Rixathon
Riximyo
RTXM 83
RTXM-83
RTXM83
Ruxience
Truxima
Kyocristine
Leurocristine Sulfate
Leurocristine, sulfate
Oncovin
Vincasar
Vincosid
Vincrex
Vincristine, sulfate
Eligibility Criteria
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Inclusion Criteria
* Documented informed consent of the participant and/or legally authorized representative
* Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria
* Both B- and T-cell phenotypes are allowed.
* CD20+ patients only: White blood cell count less than 25 x 10\^9/L prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)
* Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)
* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
* Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
* Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
* Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
* Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
* Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
* Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody \[HBc\] negative) for CD20+ patients only
* Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
* Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria
* Both B- and T-cell phenotypes are allowed.
* CD20+ patients only: White blood cell count less than 25 x 10\^9/L prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)
* Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)
* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
* Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
* Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
* Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
* Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
* Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
* Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody \[HBc\] negative) for CD20+ patients only
* Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria
* Leukemia-based therapy with chemotherapy with the exception of:
* Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
* Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
* Received previous treatment with any other asparaginase formulation
* Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab
* Known presence of Philadelphia chromosome positive (Ph+; t\[9;22\])
* Class III/IV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll
* Parenchymal central nervous system (CNS) involvement
* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment
* History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)
* Participants with history of grade ≥ 3 pancreatitis
* History of alcohol overuse if deemed relevant in investigator opinion
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
* Uncontrolled active infection
* Clinically significant uncontrolled illness
* Other active malignancy
* Females only: Pregnant or breastfeeding
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
* Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
* Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
* Received previous treatment with any other asparaginase formulation
* Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab
* Known presence of Philadelphia chromosome positive (Ph+; t\[9;22\])
* Class III/IV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll
* Parenchymal central nervous system (CNS) involvement
* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment
* History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)
* Participants with history of grade ≥ 3 pancreatitis
* History of alcohol overuse if deemed relevant in investigator opinion
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
* Uncontrolled active infection
* Clinically significant uncontrolled illness
* Other active malignancy
* Females only: Pregnant or breastfeeding
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Minimum Eligible Age
18 Years
Maximum Eligible Age
54 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
City of Hope Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ibrahim Aldoss
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope at Phoenix
Phoenix, Arizona, United States
Site Status
RECRUITING
City of Hope Medical Center
Duarte, California, United States
Site Status
RECRUITING
City of Hope at Irvine Lennar
Irvine, California, United States
Site Status
NOT_YET_RECRUITING
UC San Diego Moores Cancer Center
La Jolla, California, United States
Site Status
NOT_YET_RECRUITING
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Site Status
NOT_YET_RECRUITING
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Site Status
NOT_YET_RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
NOT_YET_RECRUITING
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
NOT_YET_RECRUITING
Countries
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United States
Facility Contacts
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Other Identifiers
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NCI-2025-02184
Identifier Type: REGISTRY
Identifier Source: secondary_id
24442
Identifier Type: OTHER
Identifier Source: secondary_id
24442
Identifier Type: -
Identifier Source: org_study_id
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