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

NCT01664910 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-07-23

Study results available
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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.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Issa Khouri · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-29
Primary Completion
2023-06-28
Completion
2023-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664910 on ClinicalTrials.gov