NCT03856216TerminatedPhase 2
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation
Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Reason given: \<75% participation
Brief summary (registry, in English)
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 stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 21 Feb 2019
- Start date
- 28 Oct 2019
- Primary completion date
- 13 Oct 2025
- Lead sponsor
- M.D. Anderson Cancer Center
- NCT number
- NCT03856216
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior autologous transplant less than 1 year prior to consent.
- 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.
Other illness
- Human immunodeficiency virus (HIV) positive.
- Active and uncontrolled disease/infection.
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
- Active hepatitis B or C.
- 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.
Lab values
- Peripheral blast count of greater than 10 K/mL.
Other
- Unable or unwilling to sign consent.
- QTcF interval > 470 ms.
Who the study is looking for
- 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.
Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center | Houston | United States | Unknown status |
Related publications
- Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.J Natl Compr Canc Netw · 2025 · PMID 41671463
This page is information, not medical advice. Discuss any trial with your doctor.