Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2008043 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-MACLO/IVAM Group | Experimental | Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy:
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Biological | Granulocyte-colony stimulating factor (G-CSF) 480 mcg subcutaneously starting on Day 13 of Cycles 1 and 3; and Day 7 of Cycles 2 and 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans. | Up to 12 years |
| Progression-Free Survival (PFS) Rate at 5 Years Using Kaplan-Meier Method | Progression-Free Survival (PFS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of participants alive without relapse or disease progression at 5 years after starting study therapy. PFS is defined as the time from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) Rate at 5 Years Using Kaplan-Meier Method | Overall Survival (OS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of survival beyond 5 years. OS is defined as elapsed time from start date of treatment to date of death from any cause. Alive participants will be censored at last date known to be alive. | 5 years |
Not provided
Inclusion Criteria:
Previously untreated, histologically confirmed mantle cell lymphoma,
Measurable or evaluable disease (at least one site with >1.5 cm in diameter
All stages are eligible
Age > 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Adequate hepatic function:
Serum creatinine< 1.5 mg/dl
Ability to give informed consent
Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
Life expectancy greater than 6 months.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Izidore S. Lossos, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33186 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33735476 | Result | Alderuccio JP, Saul EE, Iyer SG, Reis IM, Alencar AJ, Rosenblatt JD, Lossos IS. R-MACLO-IVAM regimen followed by maintenance therapy induces durable remissions in untreated mantle cell lymphoma - Long term follow up results. Am J Hematol. 2021 Jun 1;96(6):680-689. doi: 10.1002/ajh.26163. Epub 2021 Apr 7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | R-MACLO/IVAM Group | Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy:
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Jun 12, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Rituximab | Drug | Rituximab 375 mg/m^2 intravenously (IV) on Day 1 for 4 Cycles during induction therapy. Participants achieving complete remission will then receive Rituximab maintenance therapy every 6 months for up to three years. |
|
|
| Cyclophosphamide | Drug | Cyclophosphamide 800 mg/m^2 IV on Day 1 and 200 mg/m^2 IV on Days 2 through 5 of Cycles 1 and 3. |
|
|
| Cytarabine | Drug | Cytarabine (AraC) 2 grams/m^2 IV on Days 1 and 2 of Cycles 2 and 4. |
|
|
| Doxorubicin | Drug | Doxorubicin 45 mg/m^2 IV bolus on Day 1 of Cycles 1 and 3. |
|
|
| Etoposide | Drug | Etoposide (VP16) 60 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4. |
|
|
| Ifosfamide | Drug | Ifosfamide 1.5 grams/m^2 IV on Days 1 through 5 of Cycles 2 and 4. |
|
|
| Leucovorin | Drug | Leucovorin 100 mg/m^2 IV beginning 36 (+/-4) hours after start of Methotrexate infusion, and then 10 mg/m^2 at 6 hour (+/- 30 min) intervals until Methotrexate level is < 0.1 µmol/L during Cycles 1 and 3. |
|
|
| Mesna | Drug | Mesna 360 mg/m^2 IV on Days 1 through 5 of Cycles 2 and 4. |
|
|
| Methotrexate | Drug | Methotrexate (MTX) 1,200 mg/m^2 in 250 mL with Dextrose 5% in water (D5W) IV over 1 hour, followed by Methotrexate 3,000 mg/m^2 in 1,000 mL D5W by continuous infusion over 23 (+/-2) hours on Day 10 of Cycles 1 and 3. |
|
|
| Vincristine | Drug | Vincristine 1.5 mg/m^2 IV push (maximum of 2 mg) on Days 1 and 8 of Cycles 1 and 3. |
|
|
| Rate of Response to Study Therapy | The rate of response to study therapy will be reported as the number of participants achieving complete response (CR), complete response/unconfirmed (CRu) or partial response (PR) to protocol therapy according to criteria assignable to Non-Hodgkin's Lymphoma (NHL). Response assessment will be done by CT and Positron emission tomography (PET) scans, and bone marrow biopsy/aspirate, if clinically indicated. | Up to 8 years |
| Number of Participants Experiencing Treatment-Related Serious Adverse Events During R-MACLO/IVAM Induction Therapy | The number of participants experiencing treatment-related serious adverse events (SAEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician. | Up to 4 months |
| Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy | The number of participants experiencing treatment-related adverse events (AEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician. | Up to 4 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | R-MACLO/IVAM Group | Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy:
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival. |
| 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 |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Progression-Free Survival (PFS) | Progression-Free Survival (PFS) among study participants. PFS is defined as the time in years from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans. | Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy. | Posted | Median | 95% Confidence Interval | years | Up to 12 years |
|
|
| |||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) Rate at 5 Years Using Kaplan-Meier Method | Progression-Free Survival (PFS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of participants alive without relapse or disease progression at 5 years after starting study therapy. PFS is defined as the time from start of treatment to the earliest one of the following events: relapse (in patients who achieve complete response), disease progression (in patients with partial response or stable disease), or death. PFS will be evaluated by treating physician from staging Computed Tomography (CT) or Positron Emission Tomography (PET) scans. | Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy. | Posted | Number | 95% Confidence Interval | percentage probability at 5 years | 5 years |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Rate at 5 Years Using Kaplan-Meier Method | Overall Survival (OS) rate at 5 years estimated by the Kaplan-Meier method will be reported as percentage probability of survival beyond 5 years. OS is defined as elapsed time from start date of treatment to date of death from any cause. Alive participants will be censored at last date known to be alive. | Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy. | Posted | Number | 95% Confidence Interval | percentage probability at 5 years | 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Response to Study Therapy | The rate of response to study therapy will be reported as the number of participants achieving complete response (CR), complete response/unconfirmed (CRu) or partial response (PR) to protocol therapy according to criteria assignable to Non-Hodgkin's Lymphoma (NHL). Response assessment will be done by CT and Positron emission tomography (PET) scans, and bone marrow biopsy/aspirate, if clinically indicated. | Participants that completed Cycles 1 and 2 of R-MACLO/IVAM induction therapy and evaluated for response. | Posted | Count of Participants | Participants | Up to 8 years |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Treatment-Related Serious Adverse Events During R-MACLO/IVAM Induction Therapy | The number of participants experiencing treatment-related serious adverse events (SAEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician. | Posted | Count of Participants | Participants | Up to 4 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy | The number of participants experiencing treatment-related adverse events (AEs) during R-MACLO/IVAM induction therapy. AEs and SAEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0, as evaluated by treating physician. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
12 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 | R-MACLO/IVAM Group | Participants in this group will receive four 21-day cycles of combination R-MACLO/IVAM induction therapy, followed by Rituximab maintenance therapy as follows: Induction Therapy:
Maintenance Therapy: Rituximab: For study participants in complete remission. Every 6 months for up to 3 years. Total participation duration is about 4 years. Participants will be followed for survival. | 7 | 25 | 8 | 25 | 25 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chemo induced myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Appendicitis perforated | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Autoimmune reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Blood - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest wall pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatine phosphokinase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decubitus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limbs | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophageal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophageal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage nasal | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (Specify) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Upper Respiratory Infection |
|
| Infection, Anal/perianal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Mucosa | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Skin (cellulites) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Involuntary movement | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver dysfunction | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphedema-related fibrosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neck pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuralgia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: Sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Peripheral sensory neuropathy |
|
| Oral pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Petechiae | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis infective | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ureteric hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab - Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary - Other(specify) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Mild Upper respiratory infection |
|
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: Motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Peripheral motor neuropathy |
|
| Neuropathy: Cranial | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Olfactory nerve disorder |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain of skin | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Otitis, middle ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral hemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hearing (without monitoring program) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal - Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Intermittent belching |
|
| Gastrointestinal - Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Gastroesophageal Reflux Disease (GERD) |
|
| Flashing vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| External ear pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: trunk/genital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac arrhymthia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Buttock pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Basophilia |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Decreased red blood cells (RBC) |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Elevated absolute neutrophils |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Hypoglobulinemia |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Increased white blood cells (WBC) |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Leukocytosis |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Lymphocytosis |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Monocytosis |
|
| Blood - Other (Specify) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Thrombocytopenia |
|
| Bladder hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergy - Other | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (Specify) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Abdominal Infection |
|
| Infection - Other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Elevated/high Beta-2 |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Elevated/high BUN |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Decreased hematocrit (HCT) |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Decreased serum protein |
|
| Induration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Kidney pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymph node pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased Absolute Neutrophils |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased lactate dehydrogenase (LDH) |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Transaminitis |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypertriglyceridimia |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypocapnia |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypochloremia |
|
| Metabolic/Lab - Other (Specify) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypercapnia |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Izidore Lossos MD | University of Miami | +1 (305) 2434785 | ilossos@med.miami.edu |
| Jun 12, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D004317 | Doxorubicin |
| D005047 | Etoposide |
| D007069 | Ifosfamide |
| D002955 | Leucovorin |
| D015080 | Mesna |
| D008727 | Methotrexate |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D010078 | Oxazines |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D000630 | Aminopterin |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|