CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
NCT ID: NCT01664910
Last Updated: 2024-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2012-10-29
2023-06-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Allogeneic Bone Marrow Transplantation
Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin
Given IV
Bendamustine Hydrochloride
Given IV
Fludarabine Phosphate
Given IV
Inotuzumab Ozogamicin
Given IV
Methotrexate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSC transplant
Rituximab
Given IV
Tacrolimus
Given IV or PO
Interventions
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Allogeneic Bone Marrow Transplantation
Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin
Given IV
Bendamustine Hydrochloride
Given IV
Fludarabine Phosphate
Given IV
Inotuzumab Ozogamicin
Given IV
Methotrexate
Given IV
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSC transplant
Rituximab
Given IV
Tacrolimus
Given IV or PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Issa Khouri
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2012-02072
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-0265
Identifier Type: OTHER
Identifier Source: secondary_id
2012-0265
Identifier Type: -
Identifier Source: org_study_id
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