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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01664910
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 29, 2012
Status verified
Jun 2024
Primary completion
Jun 28, 2023
Completion
Jun 28, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (transplant)
    Patients receive inotuzumab ozogamicin 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 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 PO daily beginning on days -2 to 180 followed by taper in the absence of 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 BM or PBSC transplant on day 0.

Primary Outcome Measure

Maximum-tolerated Dose (MTD) of Inotuzumab Without DLT [ Time Frame: Up to 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

Related Studies