Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1931005 | Other Identifier | Alias Study Number |
Not provided
Not provided
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To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inotuzumab Ozogamicin + Rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (CMC-544) | Drug | 1.8 mg/m2, IV on day 2 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) | A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting >=7 days, 4) Grade 4 thrombocytopenia lasting >=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade <=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose >2 weeks | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response: Evaluable Population | Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544) | CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies. | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya Daini Red Cross Hospital | Aichi | 466-8650 | Japan | |||
| Tokai University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22335424 | Derived | Ogura M, Hatake K, Ando K, Tobinai K, Tokushige K, Ono C, Ishibashi T, Vandendries E. Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Sci. 2012 May;103(5):933-8. doi: 10.1111/j.1349-7006.2012.02241.x. Epub 2012 Mar 20. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Six consecutive patients were enrolled as the first cohort. The dose and administration were considered to be reasonable if <=2 participants in the first cohort experienced a dose limiting toxicity (DLT), and an additional 4 subjects were to be enrolled as the expanded cohort for a total 10 participants.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2 | Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2 | Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Dose-limiting Toxicities (DLT) | A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting >=7 days, 4) Grade 4 thrombocytopenia lasting >=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade <=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose >2 weeks | The first cohort was analyzed for DLT. | Posted | Count of Participants | Participants | Up to 28 days |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | CMC-544 1.8 mg/m^2 + Rituximab 375 mg/m^2 | Participants were treated with intravenous rituximab (375 mg/m^2) followed by intravenous CMC-544 (1.8 mg/m^2) every 28 days (±2 days) for 4 cycles (1 cycle = 28 days), and participants with at least "stable disease (SD)" after the fourth cycle received CMC-544 up to 8 cycles unless they experienced progressive disease (PD) or an unacceptable toxicity, or withdrew consent. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rituximab (Rituxan) | Drug | 375 mg/m2, IV on day 1 of each 28 day cycle; up to 8 cycles unless PD, unacceptable toxicity, or subject's refusal occurs. |
|
| Up to 8 cycles (1 cycle = 28 days) |
| Number of Participants With Objective Response: Intent-to-treat (ITT) Population | Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD. | Up to 8 cycles (1 cycle = 28 days) |
| Progression-Free Survival (PFS) | The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by >=50% in the size. | Up to 591 days |
| Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544 | The time measured for the serum concentration to decrease by one half. | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544 | AUClast= Area under the serum concentration versus time curve from time zero (pre-dose) to time of last measured concentration. | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544 | AUC∞ = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
| Clearance (CL) of CMC-544, Total Calicheamicin, and G544 | The rate at which a drug is metabolized or eliminated by normal biological processes. | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
| Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544 | The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
| Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544) | Antibody responses to CMC-544 | Up to 8 Cycles (1 cycle = 28 days) |
| Number of Participants With Positive Serum Antibody to Rituximab | Antibody responses to rituximab | Up to 8 Cycles (1 cycle = 28 days) |
| Kanagawa |
| 259-1193 |
| Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| Cancer Inst. Hp. of Japanese Foundation for Cancer Research | Tokyo | 135-8550 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Objective Response: Evaluable Population | Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD. | The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor CT scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity. | Posted | Count of Participants | Participants | Up to 8 cycles (1 cycle = 28 days) |
|
|
|
| Secondary | Number of Participants With Objective Response: Intent-to-treat (ITT) Population | Number of participants with objective response of complete response (CR), complete response unconfirmed (CRu), or partial response (PR). Objective response included subjects with CR, CRu, and PR. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: CR, normal size; CRu, normal or >75% decrease in the sum of the products of the greatest diameters (SPD); PR, normal or >=50% decrease in the SPD. | The ITT population included all participants who were enrolled in the intended dose scheme. | Posted | Count of Participants | Participants | Up to 8 cycles (1 cycle = 28 days) |
|
|
|
| Secondary | Progression-Free Survival (PFS) | The interval from the date of first administration of the test article until the first date on which relapsed disease, progressive disease (PD), or death was documented, censored at the last tumor evaluation date. Response criteria for Non-Hodgkin's Lymphoma (NHL) were based on the 1999 NCI International Workshop to standardize response criteria for NHL. Per the criteria for Lymph node masses: Relapse/PD, appearance of any new lesion or increased by >=50% in the size. | The evaluable population included all participants who received at least 2 doses of the test article and who had a baseline tumor computed tomography (CT) scan and underwent at least 1 postbaseline tumor assessment for anticancer clinical activity. | Posted | Median | 95% Confidence Interval | weeks | Up to 591 days |
|
|
|
| Other Pre-specified | Maximum Observed Serum Concentration (Cmax) of CMC-544, Total Calicheamicin, and Anti-human CD22 Antibody (G544) | CMC-544 is composed of G544, an anti-human CD22 antibody, linked to a potent cytotoxic antitumor antibiotic called calicheamicin. CD22 is expressed on the malignant cells of the majority of B-lymphocyte malignancies. | Phamacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | ng/mL | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Serum Decay Half-Life (t1/2) of CMC-544, Total Calicheamicin, and G544 | The time measured for the serum concentration to decrease by one half. | Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | hours | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CMC-544, Total Calicheamicin, and G544 | AUClast= Area under the serum concentration versus time curve from time zero (pre-dose) to time of last measured concentration. | Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | ng*hour/mL | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC∞) of CMC-544, Total Calicheamicin, and G544 | AUC∞ = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | ng*hour/mL | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Clearance (CL) of CMC-544, Total Calicheamicin, and G544 | The rate at which a drug is metabolized or eliminated by normal biological processes. | Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | L/hour | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Volume of Distribution (Vss) of CMC-544, Total Calicheamicin, and G544 | The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Pharmacokinetic population included participants who received at least 1 dose of the test article and with serum concentrations available. Number Analyzed = number of participants with the pertinent parameters calculated at the visit. | Posted | Mean | Standard Deviation | L | Cycle 1, Cycle 2 and Cycle 3 at hour 0 (predose) and at hours 1 (before the end of infusion), 4, 48, 144,192, 312, 480, and 648 relative to the start of infusion of CMC-544 |
|
|
|
| Other Pre-specified | Number of Participants With Positive Serum Antibody to Inotuzumab Ozogamicin (CMC-544) | Antibody responses to CMC-544 | The intent-to-treat (ITT) population included all participants in the intended dose scheme. | Posted | Count of Participants | Participants | Up to 8 Cycles (1 cycle = 28 days) |
|
|
|
| Other Pre-specified | Number of Participants With Positive Serum Antibody to Rituximab | Antibody responses to rituximab | The intent-to-treat (ITT) population included all participants in the intended dose scheme. | Posted | Count of Participants | Participants | Up to 8 Cycles (1 cycle = 28 days) |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| Erythropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Monocytosis | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Extravasation | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cystitis bacterial | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| Title | Measurements |
|---|---|
|
| Objective Response (CR+CRu+PR) |
|
| Title | Measurements |
|---|---|
|
| Objective Response (CR+CRu+PR) |
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|
|
| CMC-544: Cycle 3 |
|
|
| Total Calicheamicin: Cycle 1 |
|
|
| Total Calicheamicin: Cycle 2 |
|
|
| Total Calicheamicin: Cycle 3 |
|
|
| G544: Cycle 1 |
|
|
| G544: Cycle 2 |
|
|
| G544: Cycle 3 |
|
|