This study is currently recruiting participants.
Number
18-C-0026
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 1 Years Max Age: 21 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Neonates
Keywords
Bone Marrow Blasts; Extramedullary Disease; M3; M2
Recruitment Keyword(s)
None
Condition(s)
Leukemia; B-Cell; Chronic; Lymphocytic
Investigational Drug(s)
Inotuzumab Ozogamicin Cyclophosphamide
Investigational Device(s)
Intervention(s)
Biological/Vaccine: Inotuzumab Ozogamicin Biological/Vaccine: mbfm chemotherapy
Supporting Site
National Cancer Institute
B-acute lymphoblastic leukemia is a cancer known as B-ALL. If it comes back after treatment, it is relapsed. If it does not respond to treatment, it is refractory. Researchers want to see if a new drug called inotuzumab ozogamicin (InO) can help in cases of relapsed or refractory disease. InO is an antibody linked to a chemotherapy drug that targets the CD22 protein found on most leukemia cells. The antibody part of the drug helps to attach to cancer cells and once attached, the chemotherapy drug goes into the cancer cells and kills them. This drug is FDA approved for treatment of B-ALL in adults, and now it is being tested in children.
Objective:
To study the effects of inotuzumab ozogamicin on children and young adults with relapsed or refractory B-ALL.
Eligibility:
People ages 1-21 with relapsed or refractory B-ALL
Design:
Most participants will have two 1-month cycles. Some can have up to 6 cycles. The drug is given once a week for a total of three doses/cycle. It is given by IV over 60 minutes
One or two days each cycle: participants will get methotrexate injected by needle into the spinal fluid near the spinal cord. This is being given to prevent or treat leukemia in the spinal fluid.
Participants may have a central line inserted. This is a kind of IV placed in a vein, usually in the chest.
Throughout the study, participants will have:
Blood tests
Physical exams
X-rays and scans
Spinal taps
Some participants will have a pregnancy test before treatment begins.
Participants will have bone marrow aspiration at the end of each cycle to see if the cancer is responding to treatment.
Participants will have an exam and tests when they stop treatment. They will be contacted for 5 years after.
Sponsoring Institute: National Cancer Institute
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Eligibility: - Greater than or equal to 1 year and less than 22 years of age - Must have B-ALL, or previously diagnosed B-LL, with greater than or equal 5% (M2 or M3) bone marrow blasts with or without extramedullary disease - Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse - Must have one of the following: -- Second or greater relapse; -- Primary refractory disease with at least 2 prior induction attempts; -- First relapse refractory to at least one prior re-induction attempt. - Must have fully recovered from the acute toxic effects of all prior anti-cancer therapy - Adequate renal and liver function
- Greater than or equal to 1 year and less than 22 years of age
- Must have B-ALL, or previously diagnosed B-LL, with greater than or equal 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
- Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse
- Must have one of the following:
-- Second or greater relapse;
-- Primary refractory disease with at least 2 prior induction attempts;
-- First relapse refractory to at least one prior re-induction attempt.
- Must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
- Adequate renal and liver function
Principal Investigator
Referral Contact
For more information: