Trial Outcomes & Findings for Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT NCT00262925)
NCT ID: NCT00262925
Last Updated: 2015-05-05
Results Overview
Complete response requires that all of the following be present for at least four weeks. 1\. Peripheral Blood Counts: Neutrophil count \>= 1.0 x 109/L, Platelet count \>= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood. 2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines, \<= 5% blasts. 3\. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry
Results posted on
2015-05-05
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
alternative therapy
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
n=12 Participants
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|
|
Age, Customized
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entryPopulation: all enrolled patients
Complete response requires that all of the following be present for at least four weeks. 1\. Peripheral Blood Counts: Neutrophil count \>= 1.0 x 109/L, Platelet count \>= 100 x 109/L, Reduced hemoglobin concentration or hematocrit has no bearing on remission status, Leukemic blasts must not be present in the peripheral blood. 2 .Bone Marrow Aspirate and Biopsy: Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines, \<= 5% blasts. 3\. Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
Outcome measures
| Measure |
Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
n=12 Participants
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|
|
Complete Response Rate
|
33 percentage of participants
Interval 10.0 to 65.0
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryTime from registration to death from any cause. Patients alive were censored at follow up.
Outcome measures
| Measure |
Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
n=12 Participants
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|
|
Overall Survival
|
5.2 months
Interval 0.76 to 21.0
|
Adverse Events
MOAD+Campath-Step 1
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
MOAD+Campath-Step 2
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MOAD+Campath-Step 1
n=7 participants at risk
Campath 5mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
MOAD+Campath-Step 2
n=5 participants at risk
Campath 10 mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|---|
|
Investigations
CD4 decreased
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
60.0%
3/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
100.0%
7/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
100.0%
5/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
71.4%
5/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
100.0%
7/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
80.0%
4/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
85.7%
6/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
80.0%
4/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Atrial tachycardia/PAT
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hematoma
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, hemorrhage NOS
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage NOS
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, catheter relate
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, colon
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, oral cavity
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, heart
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Opportunistic infection lymphopenia>=gr1
|
0.00%
0/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection-other
|
0.00%
0/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
85.7%
6/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Ataxia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Vision-blurred
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Anus, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral cavity, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Renal failure
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
MOAD+Campath-Step 1
n=7 participants at risk
Campath 5mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
MOAD+Campath-Step 2
n=5 participants at risk
Campath 10 mg dose
INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.
CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.
CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.
MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
71.4%
5/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Hematologic-other
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
100.0%
7/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
60.0%
3/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Sweating
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Fibrinogen decreased
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Injection site reaction
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Teeth
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
85.7%
6/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
GI-other
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, oral cavity
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, upper airway
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
85.7%
6/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
71.4%
5/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
57.1%
4/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Investigations
Metabolic/Laboratory-other
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
40.0%
2/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Vision-blurred
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Tearing
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
28.6%
2/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
20.0%
1/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Oral cavity, pain
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
3/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
General disorders
Syndromes-other
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Phlebitis
|
14.3%
1/7 • Assessed every while on treatment and for 30 days after the end of treatment
|
0.00%
0/5 • Assessed every while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60