Using inotuzumab ozogamicin with chemotherapy for leukemia and lymphoma patients undergoing stem cell transplants
Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation
This study is testing if a new drug combined with chemotherapy can help leukemia and lymphoma patients do better after receiving a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | rituximab, inotuzumab, Blinatumomab, ibrutinib, chemotherapy, radiation, fludarabine, cyclophosphamide |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03856216 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study aims to evaluate the safety and efficacy of inotuzumab ozogamicin when combined with fludarabine and other chemotherapy agents before and after stem cell transplantation in patients with CD22-positive hematological malignancies. Participants will be divided into two groups based on their diagnosis: one group will focus on acute lymphoblastic leukemia and aggressive lymphoma, while the other will involve patients with indolent lymphoma. The study will assess overall survival, progression-free survival, and the incidence of graft-versus-host disease, among other outcomes. The treatment regimen includes targeted delivery of chemotherapy to cancer cells, aiming to improve patient outcomes post-transplant.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 12 to 75 with CD22-positive lymphoid malignancies, such as acute lymphoblastic leukemia or indolent lymphoma, who are eligible for reduced-intensity allogeneic stem cell transplantation.
Not a fit: Patients with non-CD22-positive malignancies or those who are not eligible for stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with leukemia and lymphoma undergoing stem cell transplantation.
How similar studies have performed: Previous studies have shown promising results with similar targeted therapies in hematological malignancies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Issa F Khouri — M.D. Anderson Cancer Center
- Study coordinator: Issa F Khouri
- Email: ikhouri@mdanderson.org
- Phone: 713-792-8750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.