CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies the side effects and the best dose of inotuzumab ozogamicin when given together with fludarabine phosphate, bendamustine hydrochloride, and rituximab before donor stem cell transplant in treating patients with lymphoid malignancies. Giving chemotherapy drugs, such as fludarabine phosphate and bendamustine hydrochloride, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal cell and helps stop the patient's immune system from rejecting the donor's stem cells. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune system response against the body's normal cells. Giving fludarabine phosphate and bendamustine hydrochloride before the transplant together with anti-thymocyte globulin and tacrolimus may stop this from happening.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Antibodies; Antibodies, Monoclonal; Antilymphocyte Serum; Antineoplastic Agents, Immunological; Bendamustine Hydrochloride; Fludarabine; Fludarabine phosphate; Immunoglobulins; Inotuzumab Ozogamicin; Lenograstim; Methotrexate; Rituximab; Tacrolimus; Thymoglobulin; Vidarabine

Criteria

Inclusion Criteria:

• Patients with B-cell hematological malignancies who are eligible for allogeneic transplantation

• Patients must have a fully-matched sibling donor or a matched unrelated donor identified

• Performance score of at least 80% by Karnofsky or 0 to 2 Eastern Cooperative Oncology Group (ECOG)

• Left ventricular ejection fraction (EF) >= 45% with no uncontrolled arrhythmias or symptomatic heart disease

• Forced expiratory volume in one second (FEV1) >= 50%

• Forced vital capacity (FVC) >= 50%

• Corrected diffusion capacity of the lung for carbon monoxide (DLCO) >= 50%

• Serum creatinine < 1.6 mg/dL

• Serum bilirubin < 2 mg/dL upper limit of normal (unless due to Gilbert's disease; patient with this disease should have a right upper quadrant ultrasound evaluation before treatment)

• Serum glutamate pyruvate transaminase (SGPT) < 2 x upper limit of normal

• Men and women of reproductive potential must agree to follow accepted birth control methods (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study

• Negative beta human chorionic gonadotropin (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:

• Patient with active central nervous system (CNS) involvement

• Known infection with human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV)-I, hepatitis B, or hepatitis C

• Patients with other malignancies diagnosed within 2 years prior to study registration; skin squamous or basal cell carcinoma are exceptions

• Active bacterial, viral or fungal infections

• History of stroke within 6 months

• History of biliary colic attack

• A prior autologous transplant within 3 months of study entry or allogeneic stem cell transplant

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study

• Patient has received other investigational drugs within 3 weeks before study registration

• Serious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectives

• Prior exposure to CMC-544 within past 6 months

• Established refractoriness to CMC-544