Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002766
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: dactinomycin
Biological: sargramostim
Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mercaptopurine
Drug: methotrexate
Drug: mitoxantrone hydrochloride
Drug: pegaspargase
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All-2 L-20
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 81 89
Completed 78 85
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             0             1
Patient Not Treated             1             2
Adverse Event             1             1
Protocol Violation             1             0
Arm/Group Title All-2 L-20 Total
Hide Arm/Group Description ARA-C/High-Dose Mitoxantrone("All-2") Standard Vincristine/Prednisone ("L-20") Total of all reporting groups
Overall Number of Baseline Participants 81 89 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 89 participants 170 participants
<=18 years
3
   3.7%
4
   4.5%
7
   4.1%
Between 18 and 65 years
76
  93.8%
77
  86.5%
153
  90.0%
>=65 years
2
   2.5%
8
   9.0%
10
   5.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 89 participants 170 participants
Female
31
  38.3%
36
  40.4%
67
  39.4%
Male
50
  61.7%
53
  59.6%
103
  60.6%
1.Primary Outcome
Title Complete Remission (CR)
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All-2 L-20
Hide Arm/Group Description:
ARA-C/High-Dose Mitoxantrone("All-2")
Standard Vincristine/Prednisone ("L-20")
Overall Number of Participants Analyzed 78 85
Measure Type: Number
Unit of Measure: participants
Complete Remission 50 50
Complete Response (CR) 14 11
Failure 5 14
Failure-Progression 8 10
Relapse 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All-2 L-20
Hide Arm/Group Description ARA-C/High-Dose Mitoxantrone("All-2") Standard Vincristine/Prednisone ("L-20")
All-Cause Mortality
All-2 L-20
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All-2 L-20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/81 (48.15%)      33/89 (37.08%)    
Blood and lymphatic system disorders     
Amylase  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Blood,Bone marrow,other  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Fibrinogen  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Hematuria  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Hemoglobin (Hgb)  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Leukocytes  1  2/81 (2.47%)  2 1/89 (1.12%)  1
Neutrophils (Leukemia)  1  1/81 (1.23%)  1 1/89 (1.12%)  1
Platelets  1  3/81 (3.70%)  4 2/89 (2.25%)  2
SGOT (AST)  1  1/81 (1.23%)  1 0/89 (0.00%)  0
SGPT (ALT)  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Neutrophils  1  0/81 (0.00%)  0 1/89 (1.12%)  1
disseminated intravascular coagulation  1  0/81 (0.00%)  0 1/89 (1.12%)  1
ALT, SGPT  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Cardiac disorders     
Cardiac left ventricle  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Cardiovascular, other  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Hypotension  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Sinus tachycardia  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Ventricular arrhythmia  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Supraventricular tachycardia  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Supravent arrhythmia  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Cardiovascular, Arrhythmia other  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Eye disorders     
Vision-blurred vision  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain/cramping  1  3/81 (3.70%)  3 0/89 (0.00%)  0
Acidosis  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Colitits  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Constipation  1  3/81 (3.70%)  3 1/89 (1.12%)  1
Diarrhea  1  1/81 (1.23%)  1 1/89 (1.12%)  1
Dysphagia, esophagitis  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Ileus (or neuroconstipation)  1  1/81 (1.23%)  1 5/89 (5.62%)  5
Nausea  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Pancreatitis  1  3/81 (3.70%)  3 1/89 (1.12%)  1
Vomiting  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Stomatitis/pharyngitis  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Gastrointestinal, other  1  0/81 (0.00%)  0 1/89 (1.12%)  1
General disorders     
Bone pain  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Febrile neutropenia  1  11/81 (13.58%)  13 13/89 (14.61%)  17
Fever  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Headache  1  1/81 (1.23%)  1 1/89 (1.12%)  1
Hemorrhage, other  1  1/81 (1.23%)  1 3/89 (3.37%)  3
Pain, other  1  1/81 (1.23%)  1 2/89 (2.25%)  2
Syncope  1  2/81 (2.47%)  2 1/89 (1.12%)  1
Epistaxis  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Dehydration  1  0/81 (0.00%)  0 2/89 (2.25%)  2
Chest pain  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Infections and infestations     
infection  1  1/81 (1.23%)  1 2/89 (2.25%)  2
Infection with grade 3/4 neutrophils  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Infection/Febrible Neutrophil-Other  1  10/81 (12.35%)  12 4/89 (4.49%)  4
Metabolism and nutrition disorders     
Bilirubin  1  3/81 (3.70%)  4 1/89 (1.12%)  1
Hyperglycemia  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Hypokalemia  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Nervous system disorders     
Neurology, other  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Neuropathy-motor  1  2/81 (2.47%)  2 2/89 (2.25%)  2
Seizure  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Dizziness  1  0/81 (0.00%)  0 2/89 (2.25%)  2
Renal and urinary disorders     
Hepatic enlargement  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Hepatic, other  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Renal failure  1  4/81 (4.94%)  4 2/89 (2.25%)  2
Respiratory, thoracic and mediastinal disorders     
Adult respiratory disorder  1  4/81 (4.94%)  4 2/89 (2.25%)  2
Ataxia  1  2/81 (2.47%)  2 0/89 (0.00%)  0
Dyspnea  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Hypoxia  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Pleural effusion  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Pulmonary, other  1  1/81 (1.23%)  1 2/89 (2.25%)  2
Thrombosis  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Ascites  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Skin and subcutaneous tissue disorders     
Hand-Foot Skin reaction  1  1/81 (1.23%)  1 0/89 (0.00%)  0
Dermatology, skin other  1  0/81 (0.00%)  0 1/89 (1.12%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All-2 L-20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/81 (60.49%)      42/89 (47.19%)    
Blood and lymphatic system disorders     
Prothrombin Time  1  0/81 (0.00%)  0 5/89 (5.62%)  5
SGPT (ALT)  1  6/81 (7.41%)  6 5/89 (5.62%)  5
Eye disorders     
Vision-blurred vision  1  0/81 (0.00%)  0 5/89 (5.62%)  5
Gastrointestinal disorders     
Abdominal pain/cramping  1  11/81 (13.58%)  11 12/89 (13.48%)  12
Stomatitis/pharyngitis  1  5/81 (6.17%)  5 10/89 (11.24%)  10
General disorders     
Anorexia  1  6/81 (7.41%)  6 5/89 (5.62%)  5
Bone pain  1  6/81 (7.41%)  6 0/89 (0.00%)  0
Fatigue  1  12/81 (14.81%)  12 15/89 (16.85%)  15
Febrile neutropenia  1  7/81 (8.64%)  7 0/89 (0.00%)  0
Insomnia  1  5/81 (6.17%)  5 0/89 (0.00%)  0
Muscle weakness  1  6/81 (7.41%)  6 0/89 (0.00%)  0
Pain, other  1  12/81 (14.81%)  12 12/89 (13.48%)  12
Rigors, chills  1  7/81 (8.64%)  7 0/89 (0.00%)  0
Metabolism and nutrition disorders     
Bilirubin  1  9/81 (11.11%)  9 6/89 (6.74%)  6
Hypokalemia  1  18/81 (22.22%)  18 14/89 (15.73%)  14
Hypomagnesemia  1  10/81 (12.35%)  10 7/89 (7.87%)  7
Hyponatremia  1  0/81 (0.00%)  0 5/89 (5.62%)  5
Hypophosphatemia  1  12/81 (14.81%)  12 13/89 (14.61%)  13
Nervous system disorders     
Dizziness  1  7/81 (8.64%)  7 6/89 (6.74%)  6
Syncope  1  6/81 (7.41%)  6 0/89 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  6/81 (7.41%)  6 7/89 (7.87%)  7
Thrombosis  1  0/81 (0.00%)  0 7/89 (7.87%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-2.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Maslak
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5518
EMail: maslakp@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00002766     History of Changes
Other Study ID Numbers: 96-015
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-96015A1
NCI-V96-0881
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: December 17, 2015
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016