Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia

Conditions

• Recurrent B Acute Lymphoblastic Leukemia
• Recurrent B Lymphoblastic Lymphoma
• Refractory B Acute Lymphoblastic Leukemia
• Refractory B Lymphoblastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

1 Year - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Asparaginase Erwinia chrysanthemi — DRUG
  Given Asparaginase Erwinia chrysanthemi
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration and Biopsy — PROCEDURE
  Undergo a bone marrow aspiration and biopsy
• Calaspargase Pegol — DRUG
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Cytarabine — DRUG
  Given IV or SC
• Diagnostic Imaging Testing — PROCEDURE
  Undergo imaging
• Inotuzumab Ozogamicin — BIOLOGICAL
  Given IV
• Leucovorin Calcium — DRUG
  Given PO or IV
• Lumbar Puncture — PROCEDURE
  Undergo lumbar puncture
• Methotrexate — DRUG
  Given IT
• Pegaspargase — DRUG
  Given IV or IM
• Vincristine — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Jun 19, 2017

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (inotuzumab ozogamicin)
  Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. (COMPLETE)
• Experimental: Cohort II (inotuzumab ozogamicin, mBFM chemotherapy)
  See Detailed Description

Primary Outcome Measure

Morphologic response (complete response [CR]+ incomplete hematologic recovery [CRi]) following one cycle of treatment with inotuzumab ozogamicin (Cohort 1) [ Time Frame: Up to 28 days ]

Locations (156)

Find similar trials in Birmingham, AL

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