Purpose

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Category

IRB Number
20180841HU
NCT Number
NCT02981628
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Principal Investigator
Anne-Marie Langevin

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu

Anne-Marie Langevin
(210) 567-7460
langevin@uthscsa.edu



Eligibility

Eligible Ages
Between 1 Year and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Recurrent B Acute Lymphoblastic Leukemia
    2. Recurrent B Lymphoblastic Lymphoma
    3. Refractory B Acute Lymphoblastic Leukemia
    4. Refractory B Lymphoblastic Lymphoma

      5. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)

      		Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15. Patients also receive cyclophosphamide IV over 30-60 on day 1; cytarabine IV over 1-30 minutes or SC on days 1-4 and 8-11; mercaptopurine PO QD on days 1-14; leucovorin calcium PO or IV on days 2, 9, 16, 23 and 37 of cycle 1 and days 9 and 37 of cycle 2; pegaspargase IV over 1-2 hours or intramuscularly (IM) on day 22; and vincristine IV on days 22 and 29. Patients receive methotrexate IT on days 1, 8 and 36 of cycle 1 and day 36 of cycle 2 for CNS 1 patients, days 1, 8, 15, 22 and 36 of cycle 1, and day 36 of cycle 2 for CNS 2 patients. CNS 3 patients receive methotrexate ITT IT on days 1, 8, 15, 22 and 36 of cycle 1 and days 8 and 36 of cycle 2. Patients assigned to inotuzumab ozogamicin dose level -2 do not receive vincristine and pegaspargase. Treatment repeats every 36 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
    5. Drug: Cytarabine

      Given IV or SC

      Other names:

      • .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

    6. Drug: Leucovorin Calcium

      Given PO or IV

      Other names:

      • Adinepar
      • Calcifolin
      • Calcium (6S)-Folinate
      • Calcium Folinate
      • Calcium Leucovorin
      • Calfolex
      • Calinat
      • Cehafolin
      • Citofolin
      • Citrec
      • Citrovorum Factor
      • C

    7. Drug: Methotrexate

      Given IT

      Other names:

      • Abitrexate
      • Alpha-Methopterin
      • Amethopterin
      • Brimexate
      • CL 14377
      • CL-14377
      • Emtexate
      • Emthexat
      • Emthexate
      • Farmitrexat
      • Fauldexato
      • Folex
      • Folex PFS

    8. Drug: Vincristine

      Given IV

      Other names:

      • Leurocristine
      • VCR
      • Vincrystine

    9. Drug: Cyclophosphamide

      Given IV

      Other names:

      • (-)-Cyclophosphamide
      • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
      • Carloxan
      • Ciclofosfamida
      • Ciclofosfamide
      • Cicloxal
      • Clafen <

    10. Biological: Inotuzumab Ozogamicin

      Given IV

      Other names:

      • Besponsa
      • CMC-544
      • Way 207294
      • WAY-207294

    11. Drug: Mercaptopurine

      Given PO

      Other names:

      • 3H-Purine-6-thiol
      • 6 MP
      • 6 Thiohypoxanthine
      • 6 Thiopurine
      • 6-Mercaptopurine
      • 6-Mercaptopurine Monohydrate
      • 6-MP
      • 6-Purinethiol
      • 6-Thiopurine
      • 6-Thioxopurine

      • Drug: Pegaspargase

        Given IV or IM

        Other names:

        • L-Asparaginase with Polyethylene Glycol
        • Oncaspar
        • Oncaspar-IV
        • PEG-Asparaginase
        • PEG-L-Asparaginase
        • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
        • PEGLA
        • Polyethylene Glyc

      12. Experimental

      Cohort I (inotuzumab ozogamicin)

      		Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
    12. Biological: Inotuzumab Ozogamicin

      Given IV

      Other names:

      • Besponsa
      • CMC-544
      • Way 207294
      • WAY-207294

      13.