Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

Launched by M.D. ANDERSON CANCER CENTER · Feb 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of leukemia and lymphoma who are preparing for a stem cell transplant. The researchers want to find out if a combination of a targeted drug called inotuzumab ozogamicin, along with common chemotherapy drugs, is safe and effective both before and after the transplant. Inotuzumab ozogamicin works by specifically targeting cancer cells, helping to kill them while aiming to preserve healthy cells. By using this treatment, the goal is to improve control over the cancer and support better outcomes for patients.

To participate in this trial, patients need to be between 12 and 70 years old and have been diagnosed with specific types of lymphoid cancer that express a protein called CD22. They should have a compatible donor for the stem cell transplant and meet certain health criteria, like having good organ function. Participants will receive the study drug and chemotherapy, and doctors will closely monitor their health throughout the process. This trial is currently recruiting participants and aims to help improve treatments for leukemia and lymphoma, potentially leading to better recovery after stem cell transplantation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 1. Creatinine less than or equal to 1.6 mg/dL
• • 2. Bilirubin less than 1.6 mg/dL
• • 3. SGPT \< 2 x UL
• • 4. Ejection fraction \>/= 40%
• • 5. 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 Criteria:
• • 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.