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Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03094611
Recruitment Status : Terminated (the study was closed early due to competing trials)
First Posted : March 29, 2017
Results First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. 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.

Condition or disease Intervention/treatment Phase
CD22 Positive Recurrent Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia Biological: Inotuzumab Ozogamicin Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet recovery [CRp] + CR with incomplete bone marrow recovery [CRi]) in patients in first, second or later salvage setting.

SECONDARY OBJECTIVES:

I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1), progression free survival (PFS), and overall survival (OS).

OUTLINE:

Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : March 11, 2020


Arm Intervention/treatment
Experimental: Treatment (inotuzumab ozogamicin)
Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.
Biological: Inotuzumab Ozogamicin
Given IV
Other Names:
  • Besponsa
  • CMC-544
  • Way 207294
  • WAY-207294




Primary Outcome Measures :
  1. Number of Participants to Achieve Complete Remission (CR) [ Time Frame: Up to 2 years ]
    Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with </= 5% blasts with a granulocyte count of 1X10^9/L or above and a platelet count of >/= 100X10^9/L and absence of extramedullary disease.


Secondary Outcome Measures :
  1. Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE) [ Time Frame: Up to 2 years ]
    For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.

  2. Duration of Response [ Time Frame: Up to 3 years ]
    The date of Complete Response to the date of loss of response or last follow-up.

  3. Progression Free Survival [ Time Frame: Up to 3 years ]
    Time from date of treatment start until the date of first objective documentation of disease-relapse.

  4. Overall Survival [ Time Frame: Up to 3 years ]
    Time from date of treatment start until date of death due to any cause or last Follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at least 12 years of age
  • Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:

    • Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,
    • Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapse
  • Performance status of 0 to 3
  • Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >= 15 mL/min as calculated using the method standard for the institution
  • Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =< 2 x ULN
  • Aspartate and alanine aminotransferase (AST or ALT) =< 2.5 x ULN
  • No active or co-existing malignancy requiring chemotherapy or radiation within 6 months
  • Female subjects of childbearing potential should be willing to use effective methods birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include birth control pills or injections, intrauterine devices (IUDs), or double-barrier methods (for example, a condom in combination with spermicide)
  • Male subjects should agree to use an effective method of contraception starting with the first dose of study therapy through the duration of treatment

Exclusion Criteria:

  • Pregnant or nursing women
  • Known to be human immunodeficiency virus (HIV)+
  • Philadelphia chromosome (Ph)+ ALL
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Unable or unwilling to sign the consent form
  • Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy within =< 4 months before first dose of study treatment
  • Active central nervous system (CNS) or extramedullary disease unless approved by the principal investigator (PI)
  • Monoclonal antibodies therapy within 2 weeks before study entry
  • Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy, hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used emergently in case of leukocytosis) or any investigational drug within 2 weeks before study entry
  • Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094611


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elias Jabbour M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03094611    
Other Study ID Numbers: 2015-0870
NCI-2018-01237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0870 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2017    Key Record Dates
Results First Posted: April 12, 2021
Last Update Posted: April 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Inotuzumab Ozogamicin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antibiotics, Antineoplastic