Trial Outcomes & Findings for Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer (NCT NCT00827099)
NCT ID: NCT00827099
Last Updated: 2012-03-23
Results Overview
100 Day TRM is death within 100 days from transplant related complications
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
100 days
Results posted on
2012-03-23
Participant Flow
Study was IRB approved on 6/8/06. The first patient was enrolled on 6/9/06. The last patient was enrolled on 12/22/08.
There were no group assignments for this study. It was a single arm cord blood transplant study.
Participant milestones
| Measure |
Umbilical Cord Blood Transplantation
1. Fludarabine 30 mg\^m2 on days -7, -6, -5, -4 \& -3
2. Melphalan 140 mg\^m2 on day -2
3. Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
4. Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
5. Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Umbilical Cord Blood Transplantation
n=5 Participants
1. Fludarabine 30 mg\^m2 on days -7, -6, -5, -4 \& -3
2. Melphalan 140 mg\^m2 on day -2
3. Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
4. Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
5. Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
35.8 years
STANDARD_DEVIATION 9.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days100 Day TRM is death within 100 days from transplant related complications
Outcome measures
| Measure |
Umbilical Cord Blood Transplant
n=5 Participants
High dose conditioning with Fludarabine \& Melphalan
|
|---|---|
|
Number of Participants With 100 Day Transplant-related Mortality (TRM)
|
0 participants
|
SECONDARY outcome
Timeframe: Day 30Number of patients whose Absolute Neutrophil Count (ANC) recovered to \>500 x10\^3/uL for at least 3 consecutive days after transplant
Outcome measures
| Measure |
Umbilical Cord Blood Transplant
n=5 Participants
High dose conditioning with Fludarabine \& Melphalan
|
|---|---|
|
Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
|
5 participants
|
SECONDARY outcome
Timeframe: day 30, day 60, day 90Population: This study was terminated early. No participants were analyzed.
Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30Population: This study was terminated early. No participants were analyzed.
Patients will be evaluated regularly for the development of graft versus host disease both acute \& chronic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 100, 6 months, 1 year, 18 months, 24 monthsPopulation: This study was terminated early. No participants were analyzed.
Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through DeathPopulation: This study was terminated early. No participants were analyzed.
Patients will be followed until death
Outcome measures
Outcome data not reported
Adverse Events
Umbilical Cord Blood Transplantation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Umbilical Cord Blood Transplantation
n=5 participants at risk
1. Fludarabine 30 mg\^m2 on days -7, -6, -5, -4 \& -3
2. Melphalan 140 mg\^m2 on day -2
3. Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)
4. Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.
5. Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
80.0%
4/5 • Number of events 4
|
|
Nervous system disorders
Cognitive Disturbance - unable to verbalize
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Cognitive disturbance - incomprehensible speech
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Confusion
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2
|
|
General disorders
Constitutional Symptoms - weakness
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 2
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
80.0%
4/5 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased Leukocytes (total WBC)
|
80.0%
4/5 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased Neutrophils/Granulocytes (ANC/AGC)
|
80.0%
4/5 • Number of events 4
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Nail slough
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - nail burning
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - skin sensitivity
|
40.0%
2/5 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - "cut on skin"
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - clubbing of fingernails
|
40.0%
2/5 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - discoloration of fingernails
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - irritation
|
40.0%
2/5 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin- burning palms
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
5/5 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Edema
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated ALK PHOS
|
20.0%
1/5 • Number of events 1
|
|
Hepatobiliary disorders
Elevated ALT
|
40.0%
2/5 • Number of events 2
|
|
Blood and lymphatic system disorders
Elevated AST
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Elevated PTT
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Elevated creatinine
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Extremity - lower (unsteady gait)
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 4
|
|
General disorders
Fever
|
100.0%
5/5 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Flushing
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal - abdominal tenderness
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal - tickle in throat
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-other (early satiety)
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Hemorrhage - GU (hemorrhagic cystitis)
|
20.0%
1/5 • Number of events 1
|
|
Reproductive system and breast disorders
Hemorrhage - GU (vaginal bleeding)
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage - oral cavity
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.0%
4/5 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
4/5 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
80.0%
4/5 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
5/5 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
80.0%
4/5 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypotension
|
40.0%
2/5 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - general bacteria
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - BK virus
|
40.0%
2/5 • Number of events 2
|
|
Infections and infestations
Infection - CMV
|
60.0%
3/5 • Number of events 3
|
|
Infections and infestations
Infection - Clostridium Difficile
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - HHV6
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - MRSA
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - MRSE
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - corynebacterium
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - enterococcus faecium
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - pneumonia
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - strep mitis
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - strep viridans
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Infection - thrush
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lymphatics - spongiosis
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Memory impairment - short attention span
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Memory impairment - short term memory loss
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Mood alteration - aggitated/restless
|
60.0%
3/5 • Number of events 3
|
|
Nervous system disorders
Mood alteration - anxiety
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Mood alteration - depression
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Mood alteration - flat affect
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Mood alteration - tearful
|
40.0%
2/5 • Number of events 2
|
|
Nervous system disorders
Mood alteration - withdrawn
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
80.0%
4/5 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Myalgia
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - aching in legs
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - arhthralgia
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 5
|
|
Psychiatric disorders
Neurology (hallucinations)
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Neuropathy - sensory (peripheral neuropathy)
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Itching eyes
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Ocular/Visual - tearing eyes
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Ocular/visual - dilated pupils
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Ocular/visual - stinging eyes
|
40.0%
2/5 • Number of events 2
|
|
Cardiac disorders
Pain - Cardiovascular (chest pain)
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Pain - Gastrointestinal (throat pain)
|
40.0%
2/5 • Number of events 2
|
|
General disorders
Pain - General (pain NOS)
|
60.0%
3/5 • Number of events 3
|
|
General disorders
Pain - Neurology (headache)
|
100.0%
5/5 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal (back pain)
|
20.0%
1/5 • Number of events 1
|
|
Reproductive system and breast disorders
Pain - sexual/reproductive function (vaginal pain)
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
80.0%
4/5 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Respiratory Failure
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - sinus congestion
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
80.0%
4/5 • Number of events 4
|
|
Renal and urinary disorders
Renal/Genitourinary - difficulty urinating
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary - dysuria
|
60.0%
3/5 • Number of events 3
|
|
Renal and urinary disorders
Renal/Genitourinary - prostate enlargement
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary - sphincter spasms
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary - urinary hesitancy
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Rigors/chills
|
80.0%
4/5 • Number of events 4
|
|
Nervous system disorders
Seizure
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
3/5 • Number of events 3
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
40.0%
2/5 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia - tachycardia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 3
|
|
Eye disorders
Watery eye
|
20.0%
1/5 • Number of events 1
|
Additional Information
Scott R. Solomon, MD
Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place