Trial Outcomes & Findings for Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma (NCT NCT00002766)
NCT ID: NCT00002766
Last Updated: 2016-02-22
Results Overview
complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count \> 1,000 x 10\^6/1, a platelet count \> 100,000 x 10\^9/1, no circulating blasts, and \< than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
170 participants
Primary outcome timeframe
2 years
Results posted on
2016-02-22
Participant Flow
Participant milestones
| Measure |
All-2
ARA-C/High-Dose Mitoxantrone("All-2") Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover.
|
L-20
Standard Vincristine/Prednisone ("L-20") Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
89
|
|
Overall Study
COMPLETED
|
78
|
85
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
All-2
ARA-C/High-Dose Mitoxantrone("All-2") Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover.
|
L-20
Standard Vincristine/Prednisone ("L-20") Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Patient Not Treated
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Baseline characteristics by cohort
| Measure |
All-2
n=81 Participants
ARA-C/High-Dose Mitoxantrone("All-2")
|
L-20
n=89 Participants
Standard Vincristine/Prednisone ("L-20")
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearscomplete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count \> 1,000 x 10\^6/1, a platelet count \> 100,000 x 10\^9/1, no circulating blasts, and \< than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.
Outcome measures
| Measure |
All-2
n=78 Participants
ARA-C/High-Dose Mitoxantrone("All-2")
|
L-20
n=85 Participants
Standard Vincristine/Prednisone ("L-20")
|
|---|---|---|
|
Complete Remission (CR)
Complete Response (CR)
|
14 participants
|
11 participants
|
|
Complete Remission (CR)
Complete Remission
|
50 participants
|
50 participants
|
|
Complete Remission (CR)
Failure
|
5 participants
|
14 participants
|
|
Complete Remission (CR)
Failure-Progression
|
8 participants
|
10 participants
|
|
Complete Remission (CR)
Relapse
|
1 participants
|
0 participants
|
Adverse Events
All-2
Serious events: 39 serious events
Other events: 49 other events
Deaths: 0 deaths
L-20
Serious events: 33 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All-2
n=81 participants at risk
ARA-C/High-Dose Mitoxantrone("All-2")
|
L-20
n=89 participants at risk
Standard Vincristine/Prednisone ("L-20")
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory disorder
|
4.9%
4/81 • Number of events 4
|
2.2%
2/89 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
3.7%
3/81 • Number of events 3
|
0.00%
0/89
|
|
Gastrointestinal disorders
Acidosis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Blood and lymphatic system disorders
Amylase
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Ataxia
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Bilirubin
|
3.7%
3/81 • Number of events 4
|
1.1%
1/89 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood,Bone marrow,other
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Bone pain
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Cardiac left ventricle
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Cardiovascular, other
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Colitits
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Gastrointestinal disorders
Constipation
|
3.7%
3/81 • Number of events 3
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia, esophagitis
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Febrile neutropenia
|
13.6%
11/81 • Number of events 13
|
14.6%
13/89 • Number of events 17
|
|
General disorders
Fever
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Blood and lymphatic system disorders
Fibrinogen
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin reaction
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Headache
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematuria
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
General disorders
Hemorrhage, other
|
1.2%
1/81 • Number of events 1
|
3.4%
3/89 • Number of events 3
|
|
Renal and urinary disorders
Hepatic enlargement
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Renal and urinary disorders
Hepatic, other
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Hypotension
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
1.2%
1/81 • Number of events 1
|
5.6%
5/89 • Number of events 5
|
|
Infections and infestations
infection
|
1.2%
1/81 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
|
Infections and infestations
Infection with grade 3/4 neutrophils
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Infections and infestations
Infection/Febrible Neutrophil-Other
|
12.3%
10/81 • Number of events 12
|
4.5%
4/89 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytes
|
2.5%
2/81 • Number of events 2
|
1.1%
1/89 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Neurology, other
|
2.5%
2/81 • Number of events 2
|
0.00%
0/89
|
|
Nervous system disorders
Neuropathy-motor
|
2.5%
2/81 • Number of events 2
|
2.2%
2/89 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutrophils (Leukemia)
|
1.2%
1/81 • Number of events 1
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Pain, other
|
1.2%
1/81 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
3.7%
3/81 • Number of events 3
|
1.1%
1/89 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
3.7%
3/81 • Number of events 4
|
2.2%
2/89 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
1.2%
1/81 • Number of events 1
|
2.2%
2/89 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
4.9%
4/81 • Number of events 4
|
2.2%
2/89 • Number of events 2
|
|
Blood and lymphatic system disorders
SGOT (AST)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Nervous system disorders
Seizure
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
General disorders
Syncope
|
2.5%
2/81 • Number of events 2
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Eye disorders
Vision-blurred vision
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/81 • Number of events 1
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Supravent arrhythmia
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Epistaxis
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/81
|
2.2%
2/89 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology, skin other
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/81
|
2.2%
2/89 • Number of events 2
|
|
Blood and lymphatic system disorders
disseminated intravascular coagulation
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Cardiac disorders
Cardiovascular, Arrhythmia other
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Ascites
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
0.00%
0/81
|
1.1%
1/89 • Number of events 1
|
Other adverse events
| Measure |
All-2
n=81 participants at risk
ARA-C/High-Dose Mitoxantrone("All-2")
|
L-20
n=89 participants at risk
Standard Vincristine/Prednisone ("L-20")
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
13.6%
11/81 • Number of events 11
|
13.5%
12/89 • Number of events 12
|
|
General disorders
Anorexia
|
7.4%
6/81 • Number of events 6
|
5.6%
5/89 • Number of events 5
|
|
Metabolism and nutrition disorders
Bilirubin
|
11.1%
9/81 • Number of events 9
|
6.7%
6/89 • Number of events 6
|
|
General disorders
Bone pain
|
7.4%
6/81 • Number of events 6
|
0.00%
0/89
|
|
Nervous system disorders
Dizziness
|
8.6%
7/81 • Number of events 7
|
6.7%
6/89 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
6/81 • Number of events 6
|
7.9%
7/89 • Number of events 7
|
|
General disorders
Fatigue
|
14.8%
12/81 • Number of events 12
|
16.9%
15/89 • Number of events 15
|
|
General disorders
Febrile neutropenia
|
8.6%
7/81 • Number of events 7
|
0.00%
0/89
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
18/81 • Number of events 18
|
15.7%
14/89 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.3%
10/81 • Number of events 10
|
7.9%
7/89 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/81
|
5.6%
5/89 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.8%
12/81 • Number of events 12
|
14.6%
13/89 • Number of events 13
|
|
General disorders
Insomnia
|
6.2%
5/81 • Number of events 5
|
0.00%
0/89
|
|
General disorders
Muscle weakness
|
7.4%
6/81 • Number of events 6
|
0.00%
0/89
|
|
General disorders
Pain, other
|
14.8%
12/81 • Number of events 12
|
13.5%
12/89 • Number of events 12
|
|
Blood and lymphatic system disorders
Prothrombin Time
|
0.00%
0/81
|
5.6%
5/89 • Number of events 5
|
|
General disorders
Rigors, chills
|
8.6%
7/81 • Number of events 7
|
0.00%
0/89
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
7.4%
6/81 • Number of events 6
|
5.6%
5/89 • Number of events 5
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
6.2%
5/81 • Number of events 5
|
11.2%
10/89 • Number of events 10
|
|
Nervous system disorders
Syncope
|
7.4%
6/81 • Number of events 6
|
0.00%
0/89
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
0.00%
0/81
|
7.9%
7/89 • Number of events 7
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/81
|
5.6%
5/89 • Number of events 5
|
Additional Information
Dr. Peter Maslak
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place