NCT01664910

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

Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin (CMC-544) Added to Fludarabine, Bendamustine and Rituximab and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To characterize the safety of anti-cluster of differentiation (CD) 22 immunoconjugate inotuzumab ozogamicin (CMC-544), when administered in conjunction with fludarabine (fludarabine phosphate), bendamustine (bendamustine hydrochloride), and rituximab as non-myeloablative preparative regimen for allogeneic stem cell transplantation for CD22-positive lymphoid malignancies. SECONDARY OBJECTIVES: I. To estimate tumor response. II. To determine overall and event-free survival rates by histology subtype. OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin. Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with matched unrelated donors (MUD) receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or orally (PO) daily beginning on days -2 to 180 followed by taper in the absence of graft-versus-host disease (GVHD) and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic bone marrow (BM) or peripheral blood stem cell (PBSC) transplant on day 0. After completion of study treatment, patients are followed up periodically.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Bone Marrow Transplantation	Undergo allogeneic BM transplant
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo allogeneic PBSC or BM transplant
BIOLOGICAL	Anti-Thymocyte Globulin	Given IV
DRUG	Bendamustine Hydrochloride	Given IV
DRUG	Fludarabine Phosphate	Given IV
BIOLOGICAL	Inotuzumab Ozogamicin	Given IV
DRUG	Methotrexate	Given IV
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo allogeneic PBSC transplant
BIOLOGICAL	Rituximab	Given IV
DRUG	Tacrolimus	Given IV or PO

Timeline

• Start date: 2012-10-29
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2012-08-14
• Last updated: 2024-07-23
• Results posted: 2024-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study