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Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00827099
Recruitment Status : Terminated (Unacceptable morbidity & mortality)
First Posted : January 22, 2009
Results First Posted : August 3, 2011
Last Update Posted : March 23, 2012
Sponsor:
Information provided by (Responsible Party):
Northside Hospital, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions Biological: anti-thymocyte globulin
Drug: fludarabine phosphate
Drug: Melphalan
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: umbilical cord blood transplantation
Enrollment 5
Recruitment Details 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.
Pre-assignment Details There were no group assignments for this study. It was a single arm cord blood transplant study.
Arm/Group Title Umbilical Cord Blood Transplantation
Hide Arm/Group Description
  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
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Umbilical Cord Blood Transplantation
Hide Arm/Group Description
  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 Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
35.8  (9.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Number of Participants With 100 Day Transplant-related Mortality (TRM)
Hide Description 100 Day TRM is death within 100 days from transplant related complications
Time Frame 100 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
Hide Description Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
3.Secondary Outcome
Title Percentage of Donor and Host Chimerism of Each Cord Blood Unit
Hide Description 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.
Time Frame day 30, day 60, day 90
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early. No participants were analyzed.
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.
Hide Description Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early. No participants were analyzed.
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Patients Who Experience Disease Relapse Post-transplant
Hide Description 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.
Time Frame Day 100, 6 months, 1 year, 18 months, 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early. No participants were analyzed.
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Patients Who Survive Following Treatment on This Protocol
Hide Description Patients will be followed until death
Time Frame Through Death
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early. No participants were analyzed.
Arm/Group Title Umbilical Cord Blood Transplant
Hide Arm/Group Description:
High dose conditioning with Fludarabine & Melphalan
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Umbilical Cord Blood Transplantation
Hide Arm/Group Description
  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
All-Cause Mortality
Umbilical Cord Blood Transplantation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Umbilical Cord Blood Transplantation
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Umbilical Cord Blood Transplantation
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Decreased Hemoglobin  1  4/5 (80.00%)  4
Decreased Leukocytes (total WBC)  1  4/5 (80.00%)  4
Decreased Neutrophils/Granulocytes (ANC/AGC)  1  4/5 (80.00%)  4
Elevated AST  1  2/5 (40.00%)  2
Thrombocytopenia  1  3/5 (60.00%)  3
Cardiac disorders   
Hypertension  1  3/5 (60.00%)  3
Pain - Cardiovascular (chest pain) * 1  1/5 (20.00%)  1
Ventricular arrhythmia - tachycardia  1  1/5 (20.00%)  1
Eye disorders   
Ocular/Visual - Itching eyes * 1  1/5 (20.00%)  1
Ocular/Visual - tearing eyes * 1  1/5 (20.00%)  1
Ocular/visual - dilated pupils  1  1/5 (20.00%)  1
Ocular/visual - stinging eyes * 1  2/5 (40.00%)  2
Watery eye  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Anorexia  1  4/5 (80.00%)  4
Constipation  1  2/5 (40.00%)  2
Dehydration  1  1/5 (20.00%)  1
Diarrhea  1  5/5 (100.00%)  5
Esophagitis  1  1/5 (20.00%)  1
Gastrointestinal - abdominal tenderness  1  2/5 (40.00%)  2
Gastrointestinal - tickle in throat * 1  1/5 (20.00%)  1
Gastrointestinal-other (early satiety) * 1  1/5 (20.00%)  1
Heartburn/dyspepsia * 1  2/5 (40.00%)  2
Hemorrhage - oral cavity  1  1/5 (20.00%)  1
Mucositis  1  4/5 (80.00%)  4
Nausea  1  5/5 (100.00%)  5
Pain - Gastrointestinal (throat pain) * 1  2/5 (40.00%)  2
Vomiting  1  3/5 (60.00%)  3
General disorders   
Constitutional Symptoms - weakness * 1  2/5 (40.00%)  2
Fatigue * 1 [1]  4/5 (80.00%)  4
Fever  1  5/5 (100.00%)  5
Pain - General (pain NOS) * 1  3/5 (60.00%)  3
Pain - Neurology (headache) * 1  5/5 (100.00%)  5
Rigors/chills * 1  4/5 (80.00%)  4
Hepatobiliary disorders   
Elevated ALT  1  2/5 (40.00%)  2
Infections and infestations   
Infection - general bacteria  1  1/5 (20.00%)  1
Infection - BK virus  1  2/5 (40.00%)  2
Infection - CMV  1  3/5 (60.00%)  3
Infection - Clostridium Difficile  1  1/5 (20.00%)  1
Infection - HHV6  1  1/5 (20.00%)  1
Infection - MRSA  1  1/5 (20.00%)  1
Infection - MRSE  1  1/5 (20.00%)  1
Infection - corynebacterium  1  1/5 (20.00%)  1
Infection - enterococcus faecium  1  1/5 (20.00%)  1
Infection - pneumonia  1  1/5 (20.00%)  1
Infection - strep mitis  1  1/5 (20.00%)  1
Infection - strep viridans  1  1/5 (20.00%)  1
Infection - thrush  1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Elevated ALK PHOS * 1  1/5 (20.00%)  1
Elevated PTT  1  1/5 (20.00%)  1
Hyperbilirubinemia  1  1/5 (20.00%)  1
Hypercalcemia  1  1/5 (20.00%)  1
Hyperglycemia  1  4/5 (80.00%)  4
Hyperkalemia  1  2/5 (40.00%)  2
Hypermagnesemia  1  1/5 (20.00%)  1
Hypernatremia  1  1/5 (20.00%)  1
Hypoalbuminemia  1  4/5 (80.00%)  4
Hypocalcemia  1  4/5 (80.00%)  4
Hypokalemia  1  3/5 (60.00%)  3
Hypomagnesemia  1  5/5 (100.00%)  5
Hyponatremia  1  4/5 (80.00%)  4
Hypophosphatemia  1  2/5 (40.00%)  2
Musculoskeletal and connective tissue disorders   
Edema  1  1/5 (20.00%)  1
Extremity - lower (unsteady gait)  1  1/5 (20.00%)  1
Lymphatics - spongiosis  1  1/5 (20.00%)  1
Musculoskeletal/Soft Tissue - Myalgia * 1  1/5 (20.00%)  1
Musculoskeletal/soft tissue - aching in legs * 1  1/5 (20.00%)  1
Musculoskeletal/soft tissue - arhthralgia * 1  2/5 (40.00%)  2
Pain - musculoskeletal (back pain) * 1  1/5 (20.00%)  1
Nervous system disorders   
Cognitive Disturbance - unable to verbalize  1  2/5 (40.00%)  2
Cognitive disturbance - incomprehensible speech  1  2/5 (40.00%)  2
Confusion  1  2/5 (40.00%)  2
Extrapyramidal/involuntary movement/restlessness  1  1/5 (20.00%)  1
Memory impairment - short attention span  1  1/5 (20.00%)  1
Memory impairment - short term memory loss  1  1/5 (20.00%)  1
Mood alteration - aggitated/restless  1  3/5 (60.00%)  3
Mood alteration - anxiety  1  2/5 (40.00%)  2
Mood alteration - depression  1  2/5 (40.00%)  2
Mood alteration - flat affect  1  1/5 (20.00%)  1
Mood alteration - tearful  1  2/5 (40.00%)  2
Mood alteration - withdrawn  1  1/5 (20.00%)  1
Neuropathy - sensory (peripheral neuropathy)  1  1/5 (20.00%)  1
Seizure  1  1/5 (20.00%)  1
Tremor  1  1/5 (20.00%)  1
Psychiatric disorders   
Insomnia * 1  1/5 (20.00%)  1
Neurology (hallucinations) * 1  1/5 (20.00%)  1
Renal and urinary disorders   
Elevated creatinine  1  1/5 (20.00%)  1
Hemorrhage - GU (hemorrhagic cystitis)  1  1/5 (20.00%)  1
Renal/Genitourinary - difficulty urinating * 1  1/5 (20.00%)  1
Renal/Genitourinary - dysuria * 1  3/5 (60.00%)  3
Renal/Genitourinary - prostate enlargement  1  1/5 (20.00%)  1
Renal/Genitourinary - sphincter spasms  1  1/5 (20.00%)  1
Renal/Genitourinary - urinary hesitancy * 1  1/5 (20.00%)  1
Urinary frequency/urgency * 1  2/5 (40.00%)  2
Urinary retention * 1  2/5 (40.00%)  2
Reproductive system and breast disorders   
Hemorrhage - GU (vaginal bleeding)  1  1/5 (20.00%)  1
Pain - sexual/reproductive function (vaginal pain)  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/5 (40.00%)  2
Dyspnea  1  2/5 (40.00%)  2
Hiccoughs  1  2/5 (40.00%)  2
Hypotension  1  2/5 (40.00%)  2
Hypoxia  1  1/5 (20.00%)  1
Pulmonary/Upper Respiratory - Respiratory Failure  1  1/5 (20.00%)  1
Pulmonary/Upper Respiratory - sinus congestion  1  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Nail slough * 1  1/5 (20.00%)  1
Dermatology/Skin - nail burning * 1  1/5 (20.00%)  1
Dermatology/Skin - skin sensitivity * 1 [2]  2/5 (40.00%)  2
Dermatology/skin - "cut on skin"  1  1/5 (20.00%)  1
Dermatology/skin - clubbing of fingernails  1  2/5 (40.00%)  2
Dermatology/skin - discoloration of fingernails * 1  1/5 (20.00%)  1
Dermatology/skin - irritation * 1  2/5 (40.00%)  2
Dermatology/skin- burning palms * 1  1/5 (20.00%)  1
Dry skin * 1  1/5 (20.00%)  1
Flushing  1  2/5 (40.00%)  2
Pruritis/itching * 1  4/5 (80.00%)  4
Rash  1  4/5 (80.00%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
fatigue & drowsiness
[2]
including soles of feet
This study was terminated early, therefore no additional data measures or outcomes are available.
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: Scott R. Solomon, MD
Organization: Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT00827099     History of Changes
Other Study ID Numbers: CDR0000632453
BMTGG-NSH-801
First Submitted: January 21, 2009
First Posted: January 22, 2009
Results First Submitted: July 28, 2011
Results First Posted: August 3, 2011
Last Update Posted: March 23, 2012