Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02072 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0265 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (transplant) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | Undergo allogeneic BM transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum-tolerated Dose (MTD) of Inotuzumab Without DLT | Number of participants received inotuzumab in each cohort without DLT | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | Overall response (CR+PR) with estimated with a 95% confidence interval in the dose that is declared the MTD. Complete Response is no clinical or radiological evidence of disease. Partial remission is equal to or more than 50% reduction in lymphadenopathy, liver and or spleen if abnormal at pre-treatment. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issa Khouri | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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All recruitment done at the University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2) | 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 at 0.6 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2022 |
Not provided
Not provided
Not provided
Not provided
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| 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 |
|
|
| Overall Survival (OS) |
Participants are disease free and alive at 3 years post transplant. |
| Up to 3 years |
| FG001 | Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2) | 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 at 1.2 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| FG002 | Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2) | 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 at 1.8 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2) | 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 at 0.6 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| BG001 | Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2) | 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 at 1.2 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| BG002 | Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2) | 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 at 1.8 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum-tolerated Dose (MTD) of Inotuzumab Without DLT | Number of participants received inotuzumab in each cohort without DLT | Posted | Count of Participants | Participants | Up to 30 days |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response | Overall response (CR+PR) with estimated with a 95% confidence interval in the dose that is declared the MTD. Complete Response is no clinical or radiological evidence of disease. Partial remission is equal to or more than 50% reduction in lymphadenopathy, liver and or spleen if abnormal at pre-treatment. | Posted | Count of Participants | Participants | Up to 3 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Participants are disease free and alive at 3 years post transplant. | Posted | Count of Participants | Participants | Up to 3 years |
|
Up to 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2) | 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 at 0.6 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2) | 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 at 1.2 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2) | 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 at 1.8 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO | 7 | 21 | 2 | 21 | 16 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| HSCT related microangiopathy (TA-TMA) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| DAH | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GI GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic GI GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Liver GvHD | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ATG fevers | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fluid overload | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bacterial Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Viral Infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated bilirubin | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia due to Chronic GvHD | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| BK virus induced hemohrragic cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic lung GvHD | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic skin GvHD | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin GvHD | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin rash due to ATG | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutropenic fevers | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic ocular GvHD | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic oral GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| GI GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fevers | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ascitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic GI GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic GvHD_Fascitis | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic liver GvHD | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic vaginal GvHD | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Elevated transminitis | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flu like syndrome | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal Infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ocular GvHD | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Venous occlusive disease | General disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Issa Khouri, MD/Stem Cell Transplantation and Cellular Therapy Department | The University of Texas MD Anderson Cancer Center | 713-745-0049 | ikhouri@mdanderson.org |
| May 15, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D000069461 | Bendamustine Hydrochloride |
| C042382 | fludarabine phosphate |
| D000080045 | Inotuzumab Ozogamicin |
| D008727 | Methotrexate |
| C015342 | merphos |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D000069283 | Rituximab |
| C000626854 | CT-P10 |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2) |
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 at 1.2 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
| OG002 | Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2) | 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 at 1.8 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
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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 at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
| OG002 | Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2) | 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 at 1.8 mg/m2 Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant Rituximab: Given IV Tacrolimus: Given IV or PO |
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