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Trial record 87 of 127 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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: NCT00262925
Recruitment Status : Terminated (slow accrual)
First Posted : December 7, 2005
Results First Posted : May 23, 2014
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Adult Acute Lymphoblastic Leukemia
Interventions Biological: alemtuzumab
Drug: asparaginase
Drug: methotrexate
Drug: dexamethasone
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: vincristine
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
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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.

Period Title: Overall Study
Started 12 [1]
Completed 1
Not Completed 11
Reason Not Completed
Lack of Efficacy             3
Adverse Event             4
Death             2
alternative therapy             1
Other             1
[1]
7 patients were enrolled to step 1, and 5 patients were enrolled to step 2
Arm/Group Title Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
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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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
All enrolled patients, and 7 were entered to the first step with 5mg Campath dose, 5 entered to the second step with 10mg Campath dose
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
35
(19 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Complete Response Rate
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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.

Time Frame 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
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Hide Analysis Population Description
all enrolled patients
Arm/Group Title Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
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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 Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33
(10 to 65)
2.Secondary Outcome
Title Overall Survival
Hide Description Time from registration to death from any cause. Patients alive were censored at follow up.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Enzyme Inhibitor Therapy)
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Detailed Description Section

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.

alemtuzumab: Given subcutaneously

asparaginase: Given IM

methotrexate: Given IV or orally

dexamethasone: Given orally

leucovorin calcium: Given IV

mercaptopurine tablet: Given orally

vincristine sulfate: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 12
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(0.76 to 21)
Time Frame Assessed every while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MOAD+Campath-Step 1 MOAD+Campath-Step 2
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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.

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.

All-Cause Mortality
MOAD+Campath-Step 1 MOAD+Campath-Step 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MOAD+Campath-Step 1 MOAD+Campath-Step 2
Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  5/7 (71.43%)  3/5 (60.00%) 
Febrile neutropenia  1  1/7 (14.29%)  0/5 (0.00%) 
Cardiac disorders     
Atrial tachycardia/PAT  1  1/7 (14.29%)  0/5 (0.00%) 
Eye disorders     
Vision-blurred  1  1/7 (14.29%)  0/5 (0.00%) 
Gastrointestinal disorders     
Constipation  1  1/7 (14.29%)  0/5 (0.00%) 
Diarrhea w/o prior colostomy  1  1/7 (14.29%)  1/5 (20.00%) 
Muco/stomatitis by exam, oral cavity  1  2/7 (28.57%)  0/5 (0.00%) 
Muco/stomatitis (symptom) oral cavity  1  1/7 (14.29%)  0/5 (0.00%) 
Abdomen, hemorrhage NOS  1  1/7 (14.29%)  0/5 (0.00%) 
Anus, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Oral cavity, pain  1  1/7 (14.29%)  0/5 (0.00%) 
General disorders     
Fatigue  1  2/7 (28.57%)  0/5 (0.00%) 
Infections and infestations     
Infection w/ gr3-4 neut, catheter relate  1  1/7 (14.29%)  0/5 (0.00%) 
Infection w/ gr3-4 neut, colon  1  1/7 (14.29%)  0/5 (0.00%) 
Infection w/ gr3-4 neut, lung  1  2/7 (28.57%)  2/5 (40.00%) 
Infection w/ gr3-4 neut, oral cavity  1  2/7 (28.57%)  0/5 (0.00%) 
Infection Gr0-2 neut, heart  1  1/7 (14.29%)  0/5 (0.00%) 
Infection Gr0-2 neut, skin  1  1/7 (14.29%)  0/5 (0.00%) 
Opportunistic infection lymphopenia>=gr1  1  0/7 (0.00%)  1/5 (20.00%) 
Infection w/ gr3-4 neut, blood  1  2/7 (28.57%)  2/5 (40.00%) 
Infection-other  1  0/7 (0.00%)  1/5 (20.00%) 
Investigations     
CD4 decreased  1  1/7 (14.29%)  0/5 (0.00%) 
Leukocytes decreased  1  7/7 (100.00%)  5/5 (100.00%) 
Lymphopenia  1  5/7 (71.43%)  1/5 (20.00%) 
Neutrophils decreased  1  7/7 (100.00%)  4/5 (80.00%) 
Platelets decreased  1  6/7 (85.71%)  4/5 (80.00%) 
Weight loss  1  1/7 (14.29%)  0/5 (0.00%) 
Alanine aminotransferase increased  1  2/7 (28.57%)  1/5 (20.00%) 
Aspartate aminotransferase increased  1  0/7 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/7 (14.29%)  0/5 (0.00%) 
Dehydration  1  1/7 (14.29%)  0/5 (0.00%) 
Hypoalbuminemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hypocalcemia  1  2/7 (28.57%)  0/5 (0.00%) 
Hyperglycemia  1  6/7 (85.71%)  1/5 (20.00%) 
Hypoglycemia  1  2/7 (28.57%)  0/5 (0.00%) 
Hyperkalemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hypokalemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hyponatremia  1  2/7 (28.57%)  0/5 (0.00%) 
Tumor lysis syndrome  1  1/7 (14.29%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders     
Extremity-limb, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Joint, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Nervous system disorders     
Ataxia  1  1/7 (14.29%)  0/5 (0.00%) 
Dizziness  1  1/7 (14.29%)  0/5 (0.00%) 
Neuropathy-motor  1  1/7 (14.29%)  0/5 (0.00%) 
Neuropathy-sensory  1  2/7 (28.57%)  0/5 (0.00%) 
Seizure  1  1/7 (14.29%)  0/5 (0.00%) 
Syncope  1  1/7 (14.29%)  0/5 (0.00%) 
Head/headache  1  1/7 (14.29%)  0/5 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/7 (14.29%)  0/5 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/7 (14.29%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory tract hemorrhage NOS  1  1/7 (14.29%)  0/5 (0.00%) 
Cough  1  1/7 (14.29%)  0/5 (0.00%) 
Dyspnea  1  3/7 (42.86%)  0/5 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  2/7 (28.57%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/7 (14.29%)  0/5 (0.00%) 
Hand-foot reaction  1  1/7 (14.29%)  0/5 (0.00%) 
Vascular disorders     
Hematoma  1  1/7 (14.29%)  0/5 (0.00%) 
Thrombosis/thrombus/embolism  1  0/7 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MOAD+Campath-Step 1 MOAD+Campath-Step 2
Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  5/7 (71.43%)  2/5 (40.00%) 
Hematologic-other  1  1/7 (14.29%)  0/5 (0.00%) 
Cardiac disorders     
Sinus tachycardia  1  2/7 (28.57%)  0/5 (0.00%) 
Eye disorders     
Vision-blurred  1  2/7 (28.57%)  1/5 (20.00%) 
Tearing  1  1/7 (14.29%)  0/5 (0.00%) 
Gastrointestinal disorders     
Constipation  1  3/7 (42.86%)  1/5 (20.00%) 
Teeth  1  1/7 (14.29%)  0/5 (0.00%) 
Diarrhea w/o prior colostomy  1  3/7 (42.86%)  1/5 (20.00%) 
Dry mouth  1  2/7 (28.57%)  0/5 (0.00%) 
Muco/stomatitis by exam, oral cavity  1  3/7 (42.86%)  2/5 (40.00%) 
Muco/stomatitis (symptom) oral cavity  1  1/7 (14.29%)  0/5 (0.00%) 
Nausea  1  6/7 (85.71%)  1/5 (20.00%) 
Vomiting  1  4/7 (57.14%)  1/5 (20.00%) 
GI-other  1  1/7 (14.29%)  0/5 (0.00%) 
Oral cavity, pain  1  3/7 (42.86%)  0/5 (0.00%) 
General disorders     
Fatigue  1  7/7 (100.00%)  3/5 (60.00%) 
Fever w/o neutropenia  1  2/7 (28.57%)  0/5 (0.00%) 
Rigors/chills  1  2/7 (28.57%)  0/5 (0.00%) 
Injection site reaction  1  3/7 (42.86%)  0/5 (0.00%) 
Edema limb  1  2/7 (28.57%)  0/5 (0.00%) 
Syndromes-other  1  1/7 (14.29%)  0/5 (0.00%) 
Infections and infestations     
Infection w/ gr3-4 neut, oral cavity  1  1/7 (14.29%)  0/5 (0.00%) 
Infection w/ gr3-4 neut, upper airway  1  1/7 (14.29%)  0/5 (0.00%) 
Infection Gr0-2 neut, oral cavity  1  2/7 (28.57%)  0/5 (0.00%) 
Infection Gr0-2 neut, sinus  1  1/7 (14.29%)  0/5 (0.00%) 
Infection Gr0-2 neut, skin  1  1/7 (14.29%)  0/5 (0.00%) 
Injury, poisoning and procedural complications     
Bruising  1  2/7 (28.57%)  1/5 (20.00%) 
Fracture  1  1/7 (14.29%)  0/5 (0.00%) 
Investigations     
Leukocytes decreased  1  3/7 (42.86%)  1/5 (20.00%) 
Lymphopenia  1  2/7 (28.57%)  0/5 (0.00%) 
Neutrophils decreased  1  4/7 (57.14%)  0/5 (0.00%) 
Platelets decreased  1  4/7 (57.14%)  0/5 (0.00%) 
Weight loss  1  1/7 (14.29%)  0/5 (0.00%) 
Fibrinogen decreased  1  1/7 (14.29%)  0/5 (0.00%) 
Alkaline phosphatase increased  1  1/7 (14.29%)  1/5 (20.00%) 
Alanine aminotransferase increased  1  6/7 (85.71%)  1/5 (20.00%) 
Aspartate aminotransferase increased  1  5/7 (71.43%)  1/5 (20.00%) 
Blood bilirubin increased  1  3/7 (42.86%)  2/5 (40.00%) 
Creatinine increased  1  3/7 (42.86%)  0/5 (0.00%) 
Metabolic/Laboratory-other  1  3/7 (42.86%)  0/5 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  4/7 (57.14%)  1/5 (20.00%) 
Dehydration  1  1/7 (14.29%)  0/5 (0.00%) 
Hypoalbuminemia  1  4/7 (57.14%)  1/5 (20.00%) 
Acidosis  1  1/7 (14.29%)  0/5 (0.00%) 
Hypocalcemia  1  2/7 (28.57%)  0/5 (0.00%) 
Hyperglycemia  1  3/7 (42.86%)  1/5 (20.00%) 
Hypoglycemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hypermagnesemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hypomagnesemia  1  1/7 (14.29%)  0/5 (0.00%) 
Hypophosphatemia  1  4/7 (57.14%)  1/5 (20.00%) 
Hyperkalemia  1  1/7 (14.29%)  1/5 (20.00%) 
Hypokalemia  1  4/7 (57.14%)  0/5 (0.00%) 
Hyponatremia  1  3/7 (42.86%)  0/5 (0.00%) 
Hyperuricemia  1  1/7 (14.29%)  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders     
Nonneuropathic lower extr muscle weak  1  1/7 (14.29%)  0/5 (0.00%) 
Nonneuropathic generalized weakness  1  2/7 (28.57%)  0/5 (0.00%) 
Musculoskeletal/soft tissue-other  1  1/7 (14.29%)  0/5 (0.00%) 
Back, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Bone, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Extremity-limb, pain  1  2/7 (28.57%)  0/5 (0.00%) 
Joint, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Muscle, pain  1  3/7 (42.86%)  1/5 (20.00%) 
Neck, pain  1  1/7 (14.29%)  0/5 (0.00%) 
Nervous system disorders     
Taste disturbance  1  1/7 (14.29%)  0/5 (0.00%) 
Dizziness  1  1/7 (14.29%)  0/5 (0.00%) 
Neuropathy-sensory  1  2/7 (28.57%)  2/5 (40.00%) 
Head/headache  1  2/7 (28.57%)  0/5 (0.00%) 
Psychiatric disorders     
Insomnia  1  3/7 (42.86%)  0/5 (0.00%) 
Anxiety  1  2/7 (28.57%)  0/5 (0.00%) 
Depression  1  1/7 (14.29%)  0/5 (0.00%) 
Renal and urinary disorders     
Glomerular filtration rate decreased  1  1/7 (14.29%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/7 (14.29%)  0/5 (0.00%) 
Nose, hemorrhage  1  1/7 (14.29%)  0/5 (0.00%) 
Cough  1  3/7 (42.86%)  0/5 (0.00%) 
Dyspnea  1  1/7 (14.29%)  0/5 (0.00%) 
Hiccoughs  1  1/7 (14.29%)  0/5 (0.00%) 
Voice changes/dysarthria  1  1/7 (14.29%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Sweating  1  3/7 (42.86%)  0/5 (0.00%) 
Dry skin  1  1/7 (14.29%)  0/5 (0.00%) 
Alopecia  1  4/7 (57.14%)  0/5 (0.00%) 
Rash/desquamation  1  2/7 (28.57%)  0/5 (0.00%) 
Skin-other  1  1/7 (14.29%)  0/5 (0.00%) 
Petechiae  1  2/7 (28.57%)  0/5 (0.00%) 
Vascular disorders     
Hypertension  1  1/7 (14.29%)  0/5 (0.00%) 
Phlebitis  1  1/7 (14.29%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262925     History of Changes
Other Study ID Numbers: NCI-2009-00518
E1904 ( Other Identifier: Eastern Cooperative Oncology Group )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: April 25, 2014
Results First Posted: May 23, 2014
Last Update Posted: May 5, 2015