Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

S
Sandeep Batra, MD

Primary Investigator

Overview

This phase III trial studies whether inotuzumab ozogamicin added to post-inductionhemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improvesutcomes. This trial also studies the outcomes of patients with mixed phenotype acuteukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy withoutuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab,ked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells ingeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapygimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin,hotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, andgaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells,her by killing the cells, by stopping them from dividing, or by stopping them fromding. This trial will also study the outcomes of patients with mixed phenotype acuteukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.
The overall goal of this study is to understand if adding inotuzumab ozogamicin to standardhemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy:duction and Consolidation. This part will collect information on the leukemia, as well ashe effects of the initial treatment, in order to classify patients into post-consolidationgroups. On the second part of this study, patients will receive the remainder ofhe chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance), with some patients randomized to receive inotuzumab. Other aims of thisudy include investigating whether treating both males and females with the same duration ofhemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oralhemotherapy regimens. Finally, this study will be the first to track the outcomes ofubjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Description

PRIMARY OBJECTIVE:
I. To determine in a randomized manner if the addition of 2 blocks of inotuzumab ozogamicindified Berlin-Frankfurt-Munster (mBFM) chemotherapy will improve 5-year disease-freeurvival (DFS) in children and young adults with high-risk (HR) B-cell acute lymphoblasticukemia (B-ALL).
SECONDARY OBJECTIVES:
I. To describe the 5-year DFS for a favorable risk subset of National Cancer Institute (NCI) HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD-MTX) interim maintenance (IM) phase and treatment duration of 2 years from the start ofgardless of sex.
II. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into theBFM chemotherapy backbone in HR B-ALL.
III. To describe the 5-year event-free survival (EFS) for patients with mixed phenotype acuteukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzivenous (IV) methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX).
IV. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cellymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IMhase with C-MTX.
EXPLORATORY OBJECTIVES:
I. To describe the therapy administered, disease response, and survival outcomes of patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy either during Induction, at end of induction (EOI), or at end of consolidation (EOC).
II. To define the prevalence and significance of minimal marrow disease (MMD) at diagnosisd bone marrow minimal residual disease (MRD) at EOI in disseminated B-LLy.
III. To determine the impact of proposed adherence-enhancing interventions on adherence to6-mercaptopurine in patients with ALL.
OUTLINE: All patients receive the same Induction and Consolidation chemotherapy. Patients with HR-Fav B-ALL are assigned to Arm I. Patients with HR B-ALL are randomized to Arm II or. Patients with MPAL are assigned to Arm IV, and patients with B-LLy are assigned to Arm V.
All patients with B-ALL receive Induction and Consolidation therapy:
INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1 and central nervous system (CNS)2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients alsove vincristine intravenously (IV) on days 1, 8, 15, and 22, daunorubicin IV over 1-15utes days 1, 8, 15, and 22, pegaspargase or calaspargase pegol IV over 1-2 hours orgaspargase intramuscularly (IM) on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone orally (PO) twice daily (BID) or IV on days 1-14; patients >= 10 years old receive prednis(ol)one PO BID or IVdays 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,ytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39,urine PO once daily (QD) on days 1-14 and 29-42, and methotrexate IT on days 1, 8, 15, and 22 (CNS3 patients receive methotrexate IT on days 1 and 8). Patients also receive vincristine IV on days 15, 22, 43, and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients with testicular diseasediagnosis that does not resolve by the end of induction will undergo radiation therapyver 12 once daily fractions. Calaspargase pegol can only be given to patients less than 22 years of age.
POST-CONSOLIDATION THERAPY: After Consolidation, based on clinical features and response,with B-ALL are designated as HR-Fav or HR B-ALL. Patients with HR-Fav B-ALL aregned to Arm I. Patients with HR B-ALL are randomized to Arm II or III. Patients with MPALd B-LLy are assigned to therapy arms (Arms IV and V) that are identical to Arm II. Patientshat are < 10 years, have CNS1, no testicular leukemia, with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks priordiagnosis, and EOI MRD < 0.01% are assigned to Arm I. Patients with HR B-ALL who areurface CD22 positive at diagnosis and have MRD < 0.01% by the end of Consolidation, aredomized to either Arm II or III.
ARM I: HR-FAV B-ALL (Patients that are < 10 years, have CNS1 status, no testicular leukemia, with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hoursds in the two weeks prior to diagnosis, and EOI MRD < 0.01%)
INTERIM MAINTENANCE: Patients receive vincristine IV on days 1, 15, 29, and 43, high dosehotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42, and 43-56, andhotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the absence of diseasegression or unacceptable toxicity.
DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IVver 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed) continues for 9 weeks in the absence of disease progression or unacceptabley. Calaspargase pegol can only be given to patients less than 22 years of age.
DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV on days 43 and 50, and pegaspargasegase pegol IV over 1-2 hours or pegaspargase IM on day 43. Treatment (Parts I andDelayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
MAINTENANCE: Patients receive methotrexate IT on days 1 and 29 for cycles 1-4, and day 1 forubsequent cycles. Patients also receive vincristine IV on day 1, prednisolone PO BID or IVdays 1-5, mercaptopurine PO QD on days 1-84, and methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1-4), 36, 43, 50, 57, 64, 71, and 78. Cycles repeat every 12 weeks for up2 years in the absence of disease progression or unacceptable toxicity.
Patients with HR B-ALL who have MRD < 0.01% by the end of Consolidation, and leukemic blastsve for surface CD22 at diagnosis are randomized to Arm II or Arm III.
ARM II: HR B-ALL (CONTROL) INTERIM MAINTENANCE I: Patients receive vincristine IV on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29 and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42,d 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in thebsence of disease progression or unacceptable toxicity.
DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IVver 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed) continues for 8 weeks in the absence of disease progression or unacceptabley. Calaspargase pegol can only be given to patients less than 22 years of age.
DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV on days 43 and 50, and pegaspargasegase pegol IV over 1-2 hours or pegaspargase IM on day 43. Treatment (Parts I andDelayed Intensification) continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
INTERIM MAINTENANCE II: Patients receive vincristine on days 1, 11, 21, 31 and 41,hotrexate IV over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31, and 41,hotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 or 23 or pegaspargase IM on days 2 and 22. Treatment continues for 8 weeks inhe absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age.
ARM III: HR B-ALL (EXPERIMENTAL) INOTUZUMAB OZOGAMICIN (InO) BLOCK 1: Patients receiveuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 and methotrexate IT on day 1. Treatment continues for 4 weeks in the absence of disease progression or unacceptabley.
INTERIM MAINTENANCE I: Patients receive vincristine IV on days 1, 15, 29 and 43, high dosehotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-56, andhotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the absence of diseasegression or unacceptable toxicity.
InO BLOCK 2: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15. Treatment continues for 4 weeks in the absence of disease progression or unacceptabley.
DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IVver 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed) continues for 8 weeks in the absence of disease progression or unacceptabley. Calaspargase pegol can only be given to patients less than 22 years of age.
DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42 (omitted/discontinued as of amendment #4), cytarabine IVver 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours orgaspargase IM on day 43. Treatment (Parts I and II of Delayed Intensification) continues8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargasegol can only be given to patients less than 22 years of age.
INTERIM MAINTENANCE II: Patients receive vincristine IV on days 1, 11, 21, 31, and 41,hotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, andgaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 or 23 or pegaspargasedays 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
ARMS II AND III: HR B-ALL MAINTENANCE: Patients receive vincristine IV on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71 and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients with CNS3 disease undergo cranial radiation therapy over 10 fractions during theweeks.
ARM IV: MPAL INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients alsove cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargasegase pegol IV over 1-2 hours or pegaspargase IM on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BIDV on days 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,ytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine POdays 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22CNS3 patients), vincristine IV on days 15, 22, 43, and 50, and pegaspargase orgase pegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatmentues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with testicular disease at diagnosis that does not resolve by the end of induction will and continued evidence of testicular disease at end of induction undergo testiculardiation over 12 once-daily fractions. Calaspargase pegol can only be given to patients lesshan 22 years of age.
ARM V: B-LLY INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients alsove cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargasegase pegol IV over 1-2 hours or pegaspargase IM on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BIDV on days 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years ofge.
CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29,ytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine POdays 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22 CNS3 patients), vincristine IV on days 15, 22, 43, and 50, and pegaspargase or calaspargasegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatment continues for 8 weekshe absence of disease progression or unacceptable toxicity. Patients with testicular disease at diagnosis that does not resolve by the end of induction will and continuedvidence of testicular disease at end of induction undergo testicular radiation therapy over 12 once-daily fractions. Calaspargase pegol can only be given to patients less than 22 yearsge.
ARM IV AND V: MPAL AND B-LLY (Post-Consolidation Therapy) INTERIM MAINTENANCE I: Patientsve vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46,hotrexate IT on days 1 and 29 and mercaptopurine PO QD on days 1-14, 15-28, 29-42, and3-56. Treatment continues for 9 weeks in the absence of disease progression or unacceptabley.
DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IVver 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed) continues for 8 weeks in the absence of disease progression or unacceptabley. Calaspargase pegol can only be given to patients less than 22 years of age.
DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43d 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day3. Treatment (Parts I and II of Delayed Intensification) continues for 8 weeks in thebsence of disease progression or unacceptable toxicity. Calaspargase pegol can only be givenhan 22 years of age.
INTERIM MAINTENANCE II: Patients receive vincristine IV on days 1, 11, 21, 31, and 41,hotrexate IV or infusion over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31, and 41,hotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 or 23 or pegaspargase IM on days 2 and 22. Treatment continues for 8 weeks inhe absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age.
MAINTENANCE: Patients receive vincristine IV on days 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22, 29 (excluded inycles 1 and 2), 36, 43, 50, 57, 64, 71, and 78, and methotrexate IT on days 1 (and 29 ofycles 1-2 for patients who do not receive cranial radiation). Cycles repeat every 12 weeksup to 2 years in the absence of disease progression or unacceptable toxicity. Patients with CNS3 disease at diagnosis undergo cranial radiation therapy for 10 fractions over 4 weeks.
Patients undergo blood sample collection and bone marrow aspiration and biopsy on study. B-LLy patients undergo computed tomography (CT), magnetic resonance imaging (MRI), positrongraphy (PET), and/or bone scan on study.
After completion of study treatment, patients are followed up at 4 weeks, then every 3 months2 years, every 4-6 months for the third year, then every 6-12 months for years 4-5.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
  • Age: Between 1 Year - 25 Years
  • Gender: All

Inclusion Criteria:
  • B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibilityudies (Part A) prior to treatment and enrollment on AALL1732. Note that centralPAL diagnosis must occur within 22 business days after enrollment forPAL patients. If not performed within this time frame, patients will be taken off.
  • APEC14B1 is not a requirement for B-LLy patients but for institutional compliancevery patient should be offered participation in APEC14B1. B-LLy patients may directlyAALL1732.
  • Patients must be > 365 days and < 25 years of age
  • White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior tohe start of protocol-directed systemic therapy):
    • Age 1-9.99 years: WBC >= 50,000/uL
    • Age 10-24.99 years: Any WBC
    • Age 1-9.99 years: WBC < 50,000/uL with:
      • Testicular leukemia
      • CNS leukemia (CNS3)
      • Steroid pretreatment.
  • White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to
    the start of protocol-directed systemic therapy):
    • Age 1-24.99 years: any WBC.
  • Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016
    criteria) with >= 25% blasts on a bone marrow (BM) aspirate;
    • OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, thediagnosis can be established by a pathologic diagnosis of acute leukemia on a BMbiopsy;
    • OR A complete blood count (CBC) documenting the presence of at least 1,000/uLulating leukemic cells if a bone marrow aspirate or biopsy cannot bed.
  • Patient has newly diagnosed B-LLy Murphy stages III or IV.
  • Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
  • Note: For B-LLy patients with tissue available for flow cytometry, the criterion fordiagnosis should be analogous to B-ALL. For tissue processed by other means (i.e.,blocks), the methodology and criteria for immunophenotypic analysis toblish the diagnosis of B-LLy defined by the submitting institution will bed.
  • All patients and/or their parents or legal guardians must sign a written informed.
  • All institutional, Food and Drug Administration (FDA), and NCI requirements for humanudies must be met.
Exclusion Criteria:
  • Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALLgible for AALL1731, regardless of NCI risk group).
  • With the exception of steroid pretreatment or the administration of intrathecalytarabine, patients must not have received any prior cytotoxic chemotherapy for theurrent diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior toherapy on AALL1732.
  • Patients who have received > 72 hours of hydroxyurea within one week prior to start ofystemic protocol therapy.
  • Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrowubmitted for APEC14B1 testing and who do not have a peripheral blood sample submittedg > 1,000/uL circulating leukemia cells.
  • Patients with acute undifferentiated leukemia (AUL) are not eligible.
  • For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroidhe following additional exclusion criteria apply:
    • T-lymphoblastic lymphoma.
    • Morphologically unclassifiable lymphoma.
    • Absence of both B-cell and T-cell phenotype markers in a case submitted asymphoblastic lymphoma.
  • Patients with known Charcot-Marie-Tooth disease.
  • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,gardless of blast immunophenotype.
  • Patients requiring radiation at diagnosis.
  • Female patients who are pregnant, since fetal toxicities and teratogenic effects havebeen noted for several of the study drugs. A pregnancy test is required for femalehildbearing potential.
  • Lactating women who plan to breastfeed their infants while on study and for 2 monthshe last dose of inotuzumab ozogamicin.
  • Sexually active patients of reproductive potential who have not agreed to use anve contraceptive method for the duration of study participation. For thosedomized to inotuzumab ozogamicin, there is a minimum of 8 months after thedose of inotuzumab ozogamicin for females and 5 months after the last dose ofuzumab ozogamicin for males.

Updated on 04 May 2024. Study ID: AALL1732
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