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S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Phase 2 trial testing arsenic trioxide in Leukemia in 78 participants. Completed in 5 February 2018.
| Lead sponsor | SWOG Cancer Research Network |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 15 November 2007 |
| Primary completion | 1 June 2017 |
| Estimated completion | 5 February 2018 |
| Sites | 192 locations across United States |
SWOG Cancer Research Network
Adults 18 to 120, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 74 | 62 – 84 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 11 | 5 – 21 |
Adverse events that were possibly, probably or definitely related to study drug are reported.
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 37 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 46 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 4 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 1 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 3 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 24 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 23 |
| Group | Value | 95% CI |
|---|---|---|
| ATRA + GO + Arsenic | 4 |
Time frame: Up to 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ATRA + GO + Arsenic |
|---|---|---|
| Platelets | Investigations | — |
| DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | — |
| Infection with unknown ANC - Blood | Infections and infestations | — |
| Infection with unknown ANC - Lung (pneumonia) | Infections and infestations | — |
| AST, SGOT | Investigations | — |
| Renal/Genitourinary-Other | Renal and urinary disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Cardiac General-Other | Cardiac disorders | — |
| SVT and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | — |
| Ileus, GI (functional obstruction of bowel) | Gastrointestinal disorders | — |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | — |
| Bilirubin (hyperbilirubinemia) | Investigations | — |
| Carbon monoxide diffusion capacity (DL(co)) | Investigations | — |
| Leukocytes (total WBC) | Investigations | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — |
| CNS cerebrovascular ischemia | Nervous system disorders | — |
| Hemorrhage, CNS | Nervous system disorders | — |
| Somnolence/depressed level of consciousness | Nervous system disorders | — |
| Carbon monoxide diffusion capacity (DL(co)) | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary/Upper Respiratory-Other | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | ATRA + GO + Arsenic |
|---|---|---|
| AST, SGOT | Investigations | — |
| Pain - Head/headache | Nervous system disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — |
| Platelets | Investigations | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Edema: limb | General disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Leukocytes (total WBC) | Investigations | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| Hypertension | Vascular disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Alkaline phosphatase | Investigations | — |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | — |
| Bilirubin (hyperbilirubinemia) | Investigations | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — |
| Prolonged QTc interval | Investigations | — |
| SVT and nodal arrhythmia - Sinus tachycardia | Cardiac disorders | — |
| Lymphopenia | Investigations | — |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | — |
| Insomnia | Psychiatric disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| DIC (disseminated intravascular coagulation) | Blood and lymphatic system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | — |
| Petechiae/purpura (hemorrhage into skin or mucosa) | Skin and subcutaneous tissue disorders | — |
| Pain - Abdomen NOS | Gastrointestinal disorders | — |
| Mood alteration - anxiety | Psychiatric disorders | — |
| Fibrinogen | Investigations | — |
| PTT (Partial thromboplastin time) | Investigations | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus/itching | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Platelets, DIC (disseminated intravascular coagulation), Infection with unknown ANC - Blood, Infection with unknown ANC - Lung (pneumonia), AST, SGOT, Renal/Genitourinary-Other, Hypoxia, Hemoglobin.
Data from ClinicalTrials.gov NCT00551460 adverse events section.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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