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Trial record 50 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome (RISE)

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: NCT00542828
Recruitment Status : Terminated (Study terminated due to slow enrollment.)
First Posted : October 12, 2007
Results First Posted : April 27, 2010
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelodysplastic Syndrome (MDS)
Intervention Biological: Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)
Enrollment 16
Recruitment Details Enrollment period: 05 November 2007 through 06 May 2009. Study participants were enrolled at 7 study centers in Europe.
Pre-assignment Details Because the study was terminated early due to slow enrollment, only 16 participants were enrolled in the study. Of these, 14 participants went on to receive treatment with Thymoglobulin.
Arm/Group Title Thymoglobulin
Hide Arm/Group Description Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Period Title: Overall Study
Started 16 [1]
Completed 3 [2]
Not Completed 13
Reason Not Completed
Physician Decision             1
Need for Prohibited Treatment             3
Study Prematurely Discontinued             7
Did Not Receive Thymoglobulin Treatment             2
[1]
Number of participants enrolled in the study; of the 16 enrolled, 14 received study treatment.
[2]
Number of participants who completed the 12-month study period.
Arm/Group Title Thymoglobulin
Hide Arm/Group Description Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
55.4  (7.67)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
<60 years 10
>=60 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Black 1
White 11
Not Reported 2
1.Primary Outcome
Title Number of Participants Who Achieved Hematologic Improvement (HI)
Hide Description This is a measure of HI in the erythroid, platelet, and neutrophil lineages. Note that HI was observed in the erythroid lineage only, which is defined as a participant who had a >=1.5 g/dL increase in hemoglobin from baseline (pretreatment value must have been <11 g/dL) and who had a relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of >=4 RBC transfusions over 8 weeks as compared with the pretreatment transfusion number in the previous 8 weeks. These criteria were taken from the 2006 International Working Group criteria.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed includes those who received treatment with Thymoglobulin and completed follow-up efficacy assessments. However, no formal efficacy analysis was conducted due to the small sample size and early study termination.
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Number of Participants With Duration of HI
Hide Description This is a measure of the duration of HI for those participants who achieved HI. Duration of HI is defined as the time from confirmation of HI response to the date of first documentation of HI relapse or death due to any cause, whichever occurs first.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants Who Achieved Disease Remission
Hide Description Disease remission is defined as a participant whose best response to therapy was a complete remission or partial remission. A complete remission is defined as: bone marrow <=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted; and peripheral blood hemoglobin >=11 g/dL, platelets >=100 x 10^9/L, neutrophils >=1.0 x 10^9/L, and blasts 0%. Partial remission is defined as: all complete remission criteria if abnormal before treatment, except bone marrow blasts decreased by >=50% over pretreatment, but still >5%; and cellularity and morphology not relevant.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Disease Remission
Hide Description This is a measure of the duration of overall disease remission only for those participants who achieved an overall remission. Duration of overall remission is defined as the time from first documentation of overall remission to the date of first documentation of disease relapse or death due to any cause, whichever occurs first.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants Who Achieved Transfusion Independence
Hide Description This is a measure of transfusion independence, which is defined as a participant with no transfusions for a period of 8 consecutive calendar weeks after first dose. Transfusion independence was to be calculated only for those participants who had documented transfusions during the 8 weeks prior to enrollment.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Duration of Transfusion Independence
Hide Description This is a measure of the duration of transfusion independence only for those participants who achieved transfusion independence. Duration of transfusion independence is defined as the longest period of time during which a participant requires no transfusions.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With a Relapse Following HI
Hide Description This is a measure of relapse following HI, which is defined as a participant who experiences at least one of the following: >=50% decrease from maximum response levels in granulocytes or platelets; >=1.5 g/dL reduction in hemoglobin; or transfusion dependence.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With a Relapse Following Overall Remission
Hide Description This is a measure of relapse following an overall remission only for participants who experienced either a complete or partial remission. Relapse following an overall remission is defined as a participant who meets any of the following criteria: a return to pretreatment bone marrow blast percentage; decrease of >=50% from maximum remission levels in neutrophils or platelets; reduction in hemoglobin concentration by >=1.5 g/dL from maximum remission levels; or transfusion dependence.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcome measure was not formally analyzed or assessed due to early study termination and small sample size (i.e., no study participants reached the 36-month time point)
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With Progression-free Survival
Hide Description This is a measure of a progression-free survival which is defined as the time from the participant’s first dose to the date of disease progression, lost to follow-up or death due to any cause, whichever occurs first.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Participants With Transformation to Acute Myeloid Leukemia
Hide Description This is a measure of transformation to acute myeloid leukemia only for participants who have bone marrow assessments. Transformation to acute myeloid leukemia is defined as the earliest date a participant experiences bone marrow blasts of >=20% after the start of treatment.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Participants With a Cytogenetic Response
Hide Description This is a measure of cytogenic response for participants whose best response to therapy is a either a complete or partial cytogenetic response. A complete cytogenetic response is defined as the disappearance of the chromosomal abnormality without appearance of new ones. A partial cytogenetic response is defined as at least 50% reduction of the chromosomal abnormality.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With a Marrow Remission
Hide Description This is a measure of bone marrow complete remission for participants who experience a remission. Bone marrow complete remission is defined as a bone marrow assessment of <=5% myeloblasts and decrease by >=50% over pretreatment.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
This secondary outcome measure was not formally analyzed or assessed due to the small sample size and early study termination (i.e., no study participants reached the 36-month time point).
Arm/Group Title Thymoglobulin
Hide Arm/Group Description:
Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected for approximately 19 months (includes all events which presented after the start of treatment through the end of study).
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title Thymoglobulin
Hide Arm/Group Description Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
All-Cause Mortality
Thymoglobulin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Thymoglobulin
Affected / at Risk (%)
Total   7/14 (50.00%) 
Cardiac disorders   
Bradycardia  1  1/14 (7.14%) 
Gastrointestinal disorders   
Constipation  1  1/14 (7.14%) 
Intestinal perforation  1  1/14 (7.14%) 
Rectal haemorrhage  1  2/14 (14.29%) 
General disorders   
Oedema peripheral  1  1/14 (7.14%) 
Pyrexia  1  1/14 (7.14%) 
Immune system disorders   
Serum sickness  1  2/14 (14.29%) 
Infections and infestations   
Cellulitis  1  1/14 (7.14%) 
Influenza  1  1/14 (7.14%) 
Sepsis  1  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/14 (7.14%) 
Myositis  1  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Myelodysplastic syndrome  1  1/14 (7.14%) 
Renal and urinary disorders   
Renal failure acute  1  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thymoglobulin
Affected / at Risk (%)
Total   14/14 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  2/14 (14.29%) 
Febrile neutropenia  1  1/14 (7.14%) 
Neutropenia  1  2/14 (14.29%) 
Pancytopenia  1  1/14 (7.14%) 
Thrombocytopenia  1  2/14 (14.29%) 
Cardiac disorders   
Arrhythmia  1  1/14 (7.14%) 
Tachycardia  1  1/14 (7.14%) 
Ear and labyrinth disorders   
Deafness  1  1/14 (7.14%) 
Eye disorders   
Conjunctival haemorrhage  1  1/14 (7.14%) 
Eye pain  1  1/14 (7.14%) 
Scleral hyperaemia  1  1/14 (7.14%) 
Visual impairment  1  1/14 (7.14%) 
Gastrointestinal disorders   
Abdominal distension  1  1/14 (7.14%) 
Abdominal pain  1  2/14 (14.29%) 
Abdominal tenderness  1  1/14 (7.14%) 
Diarrhoea  1  10/14 (71.43%) 
Dry mouth  1  3/14 (21.43%) 
Dysphagia  1  1/14 (7.14%) 
Haemorrhoidal haemorrhage  1  1/14 (7.14%) 
Mouth haemorrhage  1  1/14 (7.14%) 
Mouth ulceration  1  1/14 (7.14%) 
Nausea  1  5/14 (35.71%) 
Oral pain  1  1/14 (7.14%) 
Rectal haemorrhage  1  1/14 (7.14%) 
Toothache  1  1/14 (7.14%) 
Vomiting  1  4/14 (28.57%) 
General disorders   
Catheter site pain  1  1/14 (7.14%) 
Chills  1  3/14 (21.43%) 
Fatigue  1  3/14 (21.43%) 
Injection site reaction  1  1/14 (7.14%) 
Local swelling  1  1/14 (7.14%) 
Non-cardiac chest pain  1  1/14 (7.14%) 
Oedema  1  1/14 (7.14%) 
Oedema peripheral  1  3/14 (21.43%) 
Pyrexia  1  9/14 (64.29%) 
Immune system disorders   
Cytokine release syndrome  1  1/14 (7.14%) 
Serum sickness  1  3/14 (21.43%) 
Infections and infestations   
Central line infection  1  1/14 (7.14%) 
Epstein-Barr virus infection  1  1/14 (7.14%) 
Folliculitis  1  1/14 (7.14%) 
Gastroenteritis  1  1/14 (7.14%) 
Lower respiratory tract infection  1  1/14 (7.14%) 
Nasopharyngitis  1  2/14 (14.29%) 
Staphylococcal infection  1  1/14 (7.14%) 
Upper respiratory tract infection  1  1/14 (7.14%) 
Injury, poisoning and procedural complications   
Transfusion reaction  1  1/14 (7.14%) 
Investigations   
Blood glucose increased  1  1/14 (7.14%) 
Blood lactate dehydrogenase increased  1  1/14 (7.14%) 
Blood phosphorus decreased  1  1/14 (7.14%) 
Blood potassium decreased  1  1/14 (7.14%) 
Blood sodium increased  1  1/14 (7.14%) 
Blood urine present  1  1/14 (7.14%) 
Hepatic enzyme increased  1  1/14 (7.14%) 
Liver function test abnormal  1  1/14 (7.14%) 
Neutrophil count decreased  1  1/14 (7.14%) 
Platelet count decreased  1  2/14 (14.29%) 
Protein urine present  1  1/14 (7.14%) 
Weight increased  1  2/14 (14.29%) 
Metabolism and nutrition disorders   
Anorexia  1  1/14 (7.14%) 
Decreased appetite  1  1/14 (7.14%) 
Hyperglycaemia  1  3/14 (21.43%) 
Hypocalcaemia  1  1/14 (7.14%) 
Hypokalaemia  1  4/14 (28.57%) 
Hypomagnesaemia  1  1/14 (7.14%) 
Hypophosphataemia  1  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/14 (35.71%) 
Arthritis  1  1/14 (7.14%) 
Back pain  1  1/14 (7.14%) 
Bone pain  1  1/14 (7.14%) 
Flank pain  1  1/14 (7.14%) 
Muscle spasms  1  1/14 (7.14%) 
Musculoskeletal chest pain  1  1/14 (7.14%) 
Musculoskeletal pain  1  1/14 (7.14%) 
Myalgia  1  1/14 (7.14%) 
Neck pain  1  1/14 (7.14%) 
Pain in extremity  1  3/14 (21.43%) 
Pain in jaw  1  1/14 (7.14%) 
Nervous system disorders   
Benign intracranial hypertension  1  1/14 (7.14%) 
Dizziness  1  1/14 (7.14%) 
Dysgeusia  1  1/14 (7.14%) 
Headache  1  6/14 (42.86%) 
Lethargy  1  3/14 (21.43%) 
Paraesthesia  1  2/14 (14.29%) 
Syncope  1  1/14 (7.14%) 
Tremor  1  1/14 (7.14%) 
Psychiatric disorders   
Insomnia  1  1/14 (7.14%) 
Reproductive system and breast disorders   
Genital ulceration  1  1/14 (7.14%) 
Menorrhagia  1  1/14 (7.14%) 
Menstrual disorder  1  1/14 (7.14%) 
Sexual dysfunction  1  1/14 (7.14%) 
Vaginal haemorrhage  1  2/14 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/14 (7.14%) 
Dyspnoea  1  1/14 (7.14%) 
Dyspnoea exertional  1  1/14 (7.14%) 
Epistaxis  1  4/14 (28.57%) 
Hypoxia  1  1/14 (7.14%) 
Oropharyngeal pain  1  3/14 (21.43%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  2/14 (14.29%) 
Dermatitis allergic  1  1/14 (7.14%) 
Dry skin  1  2/14 (14.29%) 
Ecchymosis  1  1/14 (7.14%) 
Eczema  1  2/14 (14.29%) 
Erythema  1  1/14 (7.14%) 
Hyperhidrosis  1  1/14 (7.14%) 
Pain of skin  1  1/14 (7.14%) 
Petechiae  1  2/14 (14.29%) 
Pruritus  1  2/14 (14.29%) 
Pruritus generalised  1  1/14 (7.14%) 
Purpura  1  1/14 (7.14%) 
Rash  1  5/14 (35.71%) 
Rash erythematous  1  2/14 (14.29%) 
Rash macular  1  2/14 (14.29%) 
Rash maculo-papular  1  1/14 (7.14%) 
Rash pruritic  1  1/14 (7.14%) 
Skin chapped  1  1/14 (7.14%) 
Skin exfoliation  1  1/14 (7.14%) 
Skin lesion  1  1/14 (7.14%) 
Stasis dermatitis  1  1/14 (7.14%) 
Swelling face  1  1/14 (7.14%) 
Vascular disorders   
Cardiovascular insufficiency  1  1/14 (7.14%) 
Flushing  1  2/14 (14.29%) 
Hypertension  1  3/14 (21.43%) 
Hypotension  1  4/14 (28.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
The study was terminated early due to a slow enrollment rate; therefore, only safety data were collected from participants for 45 days following the last day of infusion (Day 5).
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: Genzyme MedInfo
Organization: Genzyme Corporation
Phone: 800-745-4447
EMail: medinfo@genzyme.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00542828     History of Changes
Other Study ID Numbers: ThymoHEM01206
2007-002532-28 ( EudraCT Number )
First Submitted: October 10, 2007
First Posted: October 12, 2007
Results First Submitted: April 7, 2010
Results First Posted: April 27, 2010
Last Update Posted: April 3, 2015