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Trial record 48 of 65 for:    HTLV

Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma

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ClinicalTrials.gov Identifier: NCT00061048
Recruitment Status : Completed
First Posted : May 21, 2003
Results First Posted : June 8, 2011
Last Update Posted : October 31, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute T-Cell Leukemia-Lymphoma
Intervention Biological: Alemtuzumab
Enrollment 29

Recruitment Details Anticipate enrolling 10-12 patients per year into the Campath-1H trial. Thus, if the trial goes to completion (2nd stage)we anticipate enrolling the 29 patients in approximately 2.5 years.
Pre-assignment Details  
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Period Title: Overall Study
Started 29
Completed 7 [1]
Not Completed 22
Reason Not Completed
Adverse Event             2
disease progression             20
[1]
Began protocol specified follow-up period.
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  86.2%
>=65 years
4
  13.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
52.54  (13.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
19
  65.5%
Male
10
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Overall Response Rate
Hide Description

Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.

Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.

Please see the protocol Link module for the full criteria if desired.

Time Frame 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description:
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52
(32.5 to 70.6)
2.Primary Outcome
Title Overall Survival
Hide Description Time between the first day of treatment to the day of death.
Time Frame 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description:
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(4.7 to 8.7)
3.Primary Outcome
Title Time to Progression
Hide Description Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.
Time Frame 60 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description:
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.0 to 3.9)
4.Secondary Outcome
Title Cell Surface Expression of CD52 on Tumor Cells
Hide Description The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description:
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: ABC value
82.15  (13.7)
5.Secondary Outcome
Title The Number of Participants With Adverse Events
Hide Description Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description:
Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
8
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Hide Arm/Group Description Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
All-Cause Mortality
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Affected / at Risk (%) # Events
Total   8/29 (27.59%)    
Endocrine disorders   
ENDOCRINE:: Endocrine-Other (Endocrine:hyperthyroidism graves disease)  1  1/29 (3.45%)  1
Eye disorders   
OCULAR/VISUAL:: Vision-blurred vision  1 [1]  1/29 (3.45%)  1
Gastrointestinal disorders   
GASTROINTESTINAL:: Vomiting  1 [2]  1/29 (3.45%)  1
General disorders   
CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms-Other (death)  1  2/29 (6.90%)  2
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)  1  1/29 (3.45%)  1
CONSTITUTIONAL SYMPTOMS:: Rigors, chills  1 [2]  1/29 (3.45%)  1
Infections and infestations   
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia  1 [3]  1/29 (3.45%)  1
Metabolism and nutrition disorders   
METABOLIC/LABORATORY:: Hypercalcemia  1  1/29 (3.45%)  1
Nervous system disorders   
NEUROLOGY:: Neurology-Other (Unresponsiveness)  1  1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders   
PULMONARY:: Apnea  1  1/29 (3.45%)  1
PULMONARY:: Hypoxia  1  1/29 (3.45%)  1
Vascular disorders   
CARDIOVASCULAR (GENERAL):: Hypotension  1 [4]  1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)/CTCv2
[1]
Blurred vision due to uveitis
[2]
Infusional reaction
[3]
Infection: strongyloidosis
[4]
cardiovascular; orthostatic hypotension
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Campath-1H Treatment of Adult T-cell Leukemia (ATL)
Affected / at Risk (%) # Events
Total   29/29 (100.00%)    
Blood and lymphatic system disorders   
HEMORRHAGE:: Epistaxis  1 [1]  7/29 (24.14%)  7
HEMORRHAGE:: Vaginal bleeding  1 [2]  1/29 (3.45%)  1
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection  1  1/29 (3.45%)  1
INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m  1 [3]  1/29 (3.45%)  1
INFECTION/FEBRILE NEUTROPENIA:: Infection (documented clinically or microbiologically) with grade 3  1  1/29 (3.45%)  1
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia  1 [4]  9/29 (31.03%)  17
INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (CMV antigenemia)  1  5/29 (17.24%)  5
LYMPHATICS:: Lymphatics  1 [5]  1/29 (3.45%)  1
LYMPHATICS:: Lymphatics-Other (Lymphocytes)  1  1/29 (3.45%)  1
Cardiac disorders   
CARDIOVASCULAR (ARRHYTHMIA):: Cardiovascular/Arrhythmia-Other (irregular heartbeat))  1  1/29 (3.45%)  1
CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia  1 [6]  1/29 (3.45%)  2
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia  1 [7]  5/29 (17.24%)  13
CARDIOVASCULAR (ARRHYTHMIA):: Vasovagal episode  1 [8]  3/29 (10.34%)  3
CARDIOVASCULAR (GENERAL):: Edema  1 [9]  5/29 (17.24%)  7
CARDIOVASCULAR (GENERAL):: Phlebitis (superficial)  1  2/29 (6.90%)  2
Ear and labyrinth disorders   
PAIN:: Earache (otalgia)  1  1/29 (3.45%)  1
Endocrine disorders   
ENDOCRINE:: Hypothyroidism  1  1/29 (3.45%)  2
Eye disorders   
OCULAR/VISUAL:: Dry eye  1  1/29 (3.45%)  1
OCULAR/VISUAL:: Ocular/Visual-Other (Ocular other: uveitis)  1  1/29 (3.45%)  1
OCULAR/VISUAL:: Tearing (watery eyes)  1  1/29 (3.45%)  1
OCULAR/VISUAL:: Vision-double vision (diplopia)  1  2/29 (6.90%)  2
OCULAR/VISUAL:: Vision-photophobia  1  1/29 (3.45%)  1
Gastrointestinal disorders   
GASTROINTESTINAL:: Anorexia  1  6/29 (20.69%)  6
GASTROINTESTINAL:: Constipation  1  9/29 (31.03%)  13
GASTROINTESTINAL:: Diarrhea patients without colostomy  1  10/29 (34.48%)  11
GASTROINTESTINAL:: Dyspepsia/heartburn  1  3/29 (10.34%)  3
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)  1  1/29 (3.45%)  1
GASTROINTESTINAL:: Flatulence  1  1/29 (3.45%)  1
GASTROINTESTINAL:: Gastrointestinal-Other (Abdominal distention)  1  1/29 (3.45%)  1
GASTROINTESTINAL:: Mouth dryness  1  1/29 (3.45%)  1
GASTROINTESTINAL:: Nausea  1 [10]  11/29 (37.93%)  13
GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1 [11]  3/29 (10.34%)  5
GASTROINTESTINAL:: Vomiting  1 [10]  10/29 (34.48%)  12
OCULAR/VISUAL:: Vision-blurred vision  1  2/29 (6.90%)  2
PAIN:: Abdominal pain or cramping  1  2/29 (6.90%)  2
General disorders   
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)  1 [12]  5/29 (17.24%)  6
CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<  1 [13]  22/29 (75.86%)  68
CONSTITUTIONAL SYMPTOMS:: Rigors, chills  1 [14]  25/29 (86.21%)  48
CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)  1 [15]  1/29 (3.45%)  1
CONSTITUTIONAL SYMPTOMS:: Weight gain  1 [16]  1/29 (3.45%)  1
CONSTITUTIONAL SYMPTOMS:: Weight loss  1 [17]  3/29 (10.34%)  6
PAIN:: Chest pain (non-cardiac and non-pleuritic)  1  4/29 (13.79%)  4
Hepatobiliary disorders   
HEPATIC:: Alkaline phosphatase  1  8/29 (27.59%)  10
HEPATIC:: Bilirubin  1  5/29 (17.24%)  11
HEPATIC:: GGT (Gamma-Glutamyl transpeptidase)  1  1/29 (3.45%)  1
HEPATIC:: Hypoalbuminemia  1  14/29 (48.28%)  38
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)  1 [18]  12/29 (41.38%)  22
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)  1 [19]  9/29 (31.03%)  14
Immune system disorders   
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)  1 [20]  2/29 (6.90%)  2
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  2/29 (6.90%)  2
Investigations   
BLOOD/BONE MARROW:: Hemoglobin  1 [21]  20/29 (68.97%)  81
BLOOD/BONE MARROW:: Leukocytes (total WBC)  1 [22]  15/29 (51.72%)  106
BLOOD/BONE MARROW:: Lymphopenia  1 [23]  18/29 (62.07%)  26
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)  1 [24]  11/29 (37.93%)  54
BLOOD/BONE MARROW:: Platelets  1 [25]  16/29 (55.17%)  41
COAGULATION:: Partial thromboplastin time (PTT)  1  4/29 (13.79%)  5
COAGULATION:: Prothrombin time (PT)  1  2/29 (6.90%)  2
METABOLIC/LABORATORY:: Amylase  1 [26]  2/29 (6.90%)  3
METABOLIC/LABORATORY:: Bicarbonate  1 [27]  2/29 (6.90%)  2
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)  1  2/29 (6.90%)  2
METABOLIC/LABORATORY:: Hypercalcemia  1 [28]  5/29 (17.24%)  14
METABOLIC/LABORATORY:: Hypercholesterolemia  1 [29]  1/29 (3.45%)  1
METABOLIC/LABORATORY:: Hyperglycemia  1 [30]  13/29 (44.83%)  34
METABOLIC/LABORATORY:: Hyperkalemia  1  1/29 (3.45%)  3
METABOLIC/LABORATORY:: Hypermagnesemia  1 [31]  7/29 (24.14%)  12
METABOLIC/LABORATORY:: Hypernatremia  1 [32]  1/29 (3.45%)  1
METABOLIC/LABORATORY:: Hyperuricemia  1 [33]  6/29 (20.69%)  12
METABOLIC/LABORATORY:: Hypocalcemia  1 [34]  5/29 (17.24%)  20
METABOLIC/LABORATORY:: Hypoglycemia  1 [35]  4/29 (13.79%)  4
METABOLIC/LABORATORY:: Hypokalemia  1 [36]  9/29 (31.03%)  18
METABOLIC/LABORATORY:: Hypomagnesemia  1 [37]  9/29 (31.03%)  33
METABOLIC/LABORATORY:: Hyponatremia  1 [38]  10/29 (34.48%)  27
METABOLIC/LABORATORY:: Hypophosphatemia  1 [39]  6/29 (20.69%)  19
METABOLIC/LABORATORY:: Lipase  1  1/29 (3.45%)  1
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Lactate)  1  1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders   
PAIN:: Arthralgia (joint pain)  1  3/29 (10.34%)  3
PAIN:: Bone pain  1 [40]  2/29 (6.90%)  2
PAIN:: Myalgia (muscle pain)  1 [41]  7/29 (24.14%)  13
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)  1 [42]  1/29 (3.45%)  1
Nervous system disorders   
NEUROLOGY:: Dizziness/lightheadedness  1  4/29 (13.79%)  4
NEUROLOGY:: Neuropathy - cranial  1  1/29 (3.45%)  1
NEUROLOGY:: Neuropathy - motor  1 [43]  3/29 (10.34%)  3
PAIN:: Headache  1  7/29 (24.14%)  11
PAIN:: Pain-Other (Dental-anterior pillars tender;Foot, sharp and intermittent;Right eye ache)  1 [44]  6/29 (20.69%)  7
Psychiatric disorders   
NEUROLOGY:: Insomnia  1  5/29 (17.24%)  5
NEUROLOGY:: Mood alteration-anxiety, agitation  1  1/29 (3.45%)  1
NEUROLOGY:: Mood alteration-depression  1  1/29 (3.45%)  1
Renal and urinary disorders   
RENAL/GENITOURINARY:: Creatinine  1 [45]  3/29 (10.34%)  5
RENAL/GENITOURINARY:: Hemoglobinuria  1  1/29 (3.45%)  1
RENAL/GENITOURINARY:: Proteinuria  1 [46]  3/29 (10.34%)  4
RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Urine positive for white blood cells)  1 [47]  2/29 (6.90%)  2
Reproductive system and breast disorders   
PAIN:: Pelvic pain  1 [48]  1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders   
PULMONARY:: Cough  1  5/29 (17.24%)  7
PULMONARY:: Dyspnea (shortness of breath)  1  3/29 (10.34%)  3
PULMONARY:: Hypoxia  1 [49]  2/29 (6.90%)  5
PULMONARY:: Pneumonitis/pulmonary infiltrates  1  1/29 (3.45%)  1
PULMONARY:: Pneumothorax  1  1/29 (3.45%)  1
Skin and subcutaneous tissue disorders   
DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia)  1 [50]  1/29 (3.45%)  2
DERMATOLOGY/SKIN:: Dry skin  1  3/29 (10.34%)  3
DERMATOLOGY/SKIN:: Injection site reaction  1 [51]  1/29 (3.45%)  1
DERMATOLOGY/SKIN:: Pruritus  1 [52]  8/29 (27.59%)  10
DERMATOLOGY/SKIN:: Rash/desquamation  1 [53]  8/29 (27.59%)  12
DERMATOLOGY/SKIN:: Urticaria (hives, welts, wheals)  1 [54]  11/29 (37.93%)  15
DERMATOLOGY/SKIN::Dermatology/Skin-Other(Thumb swelling)  1  1/29 (3.45%)  1
Vascular disorders   
CARDIOVASCULAR (GENERAL):: Hypertension  1 [55]  2/29 (6.90%)  2
CARDIOVASCULAR (GENERAL):: Hypotension  1 [56]  11/29 (37.93%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)/CTCv2
[1]
Dry due to membrane inflammation
[2]
Spotting
[3]
Fever
[4]
CMV CMV(+) Methicillin staphyloccocus aureus (+) Nares (-) Sinus infection (staph aureus) Infection without neutropenia streptococcus Infection: strongyloidosis Left inguinal cellulitis-redness
[5]
Left inguinal swelling
[6]
Sinus bradycardia
[7]
Sinus tachycardia
[8]
Vasovagal episode, Fall
[9]
Bilat foot, legs, ankle edema Edema: face, forearm, hands, legs Facial swelling Ankles to knees edema Pitting
[10]
Infusional reaction
[11]
Tongue and oral mucosa stomatitis
[12]
Fatigue Fatigue (lethargy, malaise, asthenia) Fever
[13]
Fever Infusional reaction
[14]
Chills Infusional reaction Mild chills Rigors Rigors, chills Chills with Campath Infusional reaction occurred overnight
[15]
Sweating (diaphoresis)
[16]
Ankle edema (increase wt)
[17]
Weight loss
[18]
Aspartate aminotransferase
[19]
Alanine aminotransferase
[20]
Allergy: infusional reaction
[21]
Anemia Hemoglobin
[22]
Decrease WBC
[23]
Lymphopenia Low lymphocytes
[24]
ANC
[25]
Platelets
[26]
Amylase
[27]
Bicarbonate
[28]
Hypercalcemia
[29]
Hypercholesterolemia
[30]
Hyperglycemia
[31]
Hypermagnesemia
[32]
Hypernatremia
[33]
Hyperuricemia
[34]
Hypocalcemia
[35]
Hypoglycemia
[36]
Hypokalemia
[37]
Hypomagnesemia
[38]
Hyponatremia
[39]
Hypophosphatemia
[40]
During infusion, probable bone marrow involvement with disease
[41]
Back pain Generalized achiness/pain Low back pain Low back, hip pain Right thoracic pain muscular Tendonitis right shoulder Back abdominal pain
[42]
Pain: right inguinal, (new lymph node)
[43]
Tremor
[44]
Peripherally inserted central catheter site pain Pain other: pain in eyes Pain: in right finger Pain: in right shoulder
[45]
Creatinine
[46]
Proteinuria
[47]
UTI
[48]
Left inguinal pain
[49]
Infusional reaction Infusional reaction, occurred overnight
[50]
Abdominal bruising, ecchymosis
[51]
Derm: swelling in right arm injection site reaction
[52]
Itching
[53]
Skin rash papules (on breast, chest)
[54]
Derm: hives, infusion reaction 20 min post Campath On thighs and stomach
[55]
Hypertension
[56]
Hypotension Orthostatic hypotension only after Campath infusions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Thomas A. Waldmann, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-6653
Responsible Party: Thomas A. Waldmann, M.D., National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00061048     History of Changes
Obsolete Identifiers: NCT00064155
Other Study ID Numbers: 030194
03-C-0194 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
030194 ( Other Identifier: Clinical Center (CC), National Institutes of Health (NIH) )
First Submitted: May 20, 2003
First Posted: May 21, 2003
Results First Submitted: May 17, 2011
Results First Posted: June 8, 2011
Last Update Posted: October 31, 2012