Status:
TERMINATED
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a st...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the safety of the addition of inotuzumab ozogamicin (IO) pre- and post-allogeneic transplantation in patients with CD22-positive hematological malignancies. SECONDARY...
Eligibility Criteria
Inclusion
- Participants age 12 to 75.
- English and non-English speaking participants are eligible.
- CD22+ lymphoid malignancies including B-ALL
- Eligible to receive a reduced-intensity alloSCT
- Participants with:
- Indolent lymphoma participants who failed conventional treatment; or,
- Acute lymphoblastic leukemia (ALL), aggressive lymphoma, indolent lymphoma in transformation, or those who have failed ≥ three small molecule inhibitors
- Donor: HLA compatible (8/8 match) related or matched unrelated donor (HLA-A, B, C, DRB1) or mismatched MUD (7/8 match) or haploidentical
- Performance status of 0 to 2, Lansky ≥ 80 for \< 16 years and Karnofsky ≥ 80 for ≥ 16 years of age.
- Adequate organ function at time of study entry
- Creatinine less than or equal to 1.6 mg/dL
- Bilirubin less than 1.6 mg/dL
- SGPT \< 2 x UL
- Ejection fraction \>/= 40%
- FEV1, FVC and cDLCO \>/= 40%
- Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Exclusion
- Human immunodeficiency virus (HIV) positive.
- Prior autologous transplant less than 1 year prior to consent.
- Active and uncontrolled disease/infection.
- Unable or unwilling to sign consent.
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
- Active hepatitis B or C.
- Recent systemic chemotherapy or radiation within 3 weeks of study entry (intrathecal therapy is allowed).
- Standard biological agents such as rituximab, TKIs such as ibrutinib and venetoclax are allowed to be given within 3 days prior to receiving inotuzumab ozogamicin. Blinatumomab is allowed to be given until 1 week prior to Day -13 inotuzumab ozogamicin on study.
- Prior inotuzumab ozogamicin within 3 weeks of study entry.
- Peripheral blast count of greater than 10 K/mL.
- QTcF interval \> 470 ms.
- Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03856216
Start Date
October 28 2019
End Date
October 13 2025
Last Update
October 16 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030