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
|Condition or disease||Intervention/treatment||Phase|
|CD22 Positive Recurrent Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia||Biological: Inotuzumab Ozogamicin||Phase 2|
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.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|