Randomized Double Cord Blood Transplant Study
Study Details
Study Description
Brief Summary
The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Cord blood is a source of blood forming cells that can be used for transplantation. The major problem with this type of transplant is the small number of blood forming cells available in each cord unit, which may delay the "take" of the graft in the recipient. Two strategies may be used to try to overcome this problem. One method is the combination of 2 units of cord blood and the other is the growing of the cord blood cells in the laboratory before they are transplanted in order to increase their number.
Participants will be randomly assigned (as in the toss of a coin) to one of two groups. If you are assigned to Study Arm 1, you will receive two cord blood units combined without growing the cells in the laboratory. If you are assigned to Study Arm 2, you will receive one cord blood unit combined with one cord blood unit which will be grown in the laboratory for two weeks before you receive it. Neither you nor your doctors will know in advance to which arm you will be assigned.
Placement of central venous catheter for collection of "back-up" stem cells:
Before you have back-up stem cell collected or you receive chemotherapy, you will require placement of a hollow plastic tube (catheter) into a large vein inside your body. This catheter will be used to draw blood and to give medications and fluids. The catheter is inserted through the skin in the upper chest and extends into the right side of your heart. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for it.
Collection of back up stem cells:
Because collecting additional cells from the donor of the cord blood will not be possible if the transplant with cord blood fails, a back up blood or bone marrow sample will be collected from you and frozen before the high dose chemotherapy begins.
Peripheral blood progenitor cell collection (Leukapheresis):
Before collection of the blood stem cells, you will be treated with a drug called granulocyte colony stimulating factor (G-CSF), which will cause the important stem cells in the marrow to move the peripheral blood where they will be collected. This medication is given as a shot under the skin once a day for 3 - 7 days, at which time your blood stem cells will be collected from your central catheter during a 3-4 hour out-patient procedure. In some cases where a "good vein" cannot be accessed, a silicone venous catheter may be needed to collect your blood.
Bone Marrow Collection:
If the leukapheresis cannot be performed successfully, you will receive general anesthesia in the operating room and will have multiple needle sticks of the hip bones in order to collect bone marrow. Only a small part of your bone marrow (<5%) will be taken.
Selection of another donor as the alternate source of stem cells:
If your bone marrow or back-up blood stem cells cannot be collected, a family member whose bone marrow is the closest match will be chosen as the back up donor. The potential donor would have testing performed to assure that he/she is eligible to donate.
High-dose therapy:
Your bone marrow transplant doctors will give you one of four chemotherapy treatments, which are discussed below. If you have acute lymphoblastic leukemia, lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, acute myelogenous leukemia, myelodysplastic syndrome, chronic eosinophilic leukemia or chronic myelogenous leukemia, are less than 61 years old, and can receive high-dose chemotherapy, you may be assigned to Treatment Regimen #1 - fludarabine-thiotepa-melphalan. Patients with ALL may be assigned to Treatment Regimen #1 or #3, depending on your doctor's evaluation, age and physical fitness.
You will receive melphalan as a single dose on Day -8, thiotepa as a single dose on Day -7, followed by fludarabine given once a day for 4 days in a row (Days -6 through -3. Rituximab may be given on Day -9 if appropriate for your disease. Day 0 is the day of transplantation, so the negative day numbers are used to label the treatment days before transplant.
If you have any of the diseases listed above, have had a bone marrow transplant in the past, or have a physical that makes you less likely to tolerate high-dose therapy well, you will be in the less aggressive Treatment Regimen #2, Fludarabine, Cyclophosphamide and low dose total body irradiation. The fludarabine will be given on Days -6, -5, -4, and -3. The cyclophosphamide will be given on Day -6. Irradiation will be given on day -1. Rituxan may be given on Day -7 if appropriate for your disease.
If you have acute lymphoblastic leukemia, are 50 years old or younger, and your doctors have decided that full-dose Total body irradiation is the best treatment for you, you will be assigned to Treatment Regimen #3 - total body irradiation-VP16. You will receive total body irradiation on Days -7,-6, -5 and -4, followed by VP16 (also known as etoposide) as a single dose on Day -3. Rituximab may be given on Day -8 if appropriate for your disease.
All chemotherapy, fluids and other medications that must be given by vein will be infused through your catheter. Once the backup stem cells are collected, all patients will be admitted to the hospital on Day -9 to begin receiving fluids. Chemotherapy may be stopped if intolerable side effects occur.
Expansion of expanded cord blood:
On Day -14, if you are in Treatment Group 2, one of your two cord blood units will be thawed and treated in the MD Anderson Stem Cell Laboratory with vitamin-like growth factors for 2 weeks before they are given back to you on day zero as described below. A small amount of cord blood cells (less than 3%) will be used for laboratory procedures that measure the quality of the product.
The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.
Transplantation of cord blood:
If you are in Treatment Group 1, two days following completion of high-dose therapy (Day 0), both units of cord blood will be thawed and infused (one at a time) through your catheter. Each unit will take about 30 minutes to infuse. Patients in Treatment Group 2 will receive one unit of cord blood that did not go through expansion of cells, followed by infusion of the unit that was grown in the laboratory for 14 days.
Graft versus host disease (GVHD) preventive therapy:
GVHD results from a reaction of the transplanted cord blood cells against certain tissues in your body. In an attempt to prevent or decrease the severity of GVHD, you will receive two drugs.
Mycophenolate mophetyl (MMF) pills will be given starting three days before your transplant, and will be continued until day 30 after the cord blood transplant. If you cannot take pills, the drug can be given through your catheter. If you develop GVHD, the use of MMF may be prolonged.
Tacrolimus will be given as a 24 hour continuous infusion over 3-6 weeks. Around Day 30 or 40 (after engraftment), the tacrolimus will be changed to pills given daily for 6-9 months. The number of tacrolimus pills may vary according to the blood levels of the drug, but usually are between 1 - 5. This medicine is used for 6-9 months (longer if chronic GVHD occurs).
You will remain on study as long as your disease does not return. If your disease returns, you will be taken off study and you may be offered participation in another study or be treated outside of this study.
Follow-up after transplant:
After you leave the hospital, you will be seen regularly in the Department of Blood and Marrow Transplantation at MD Anderson. The frequency of the visits may vary, but may be as often as daily. Blood (1-2 tablespoons) and urine tests will be performed. The frequency of blood tests may also vary, but may be performed daily. Patients will need a bone marrow sample collected before transplant and at 1 month, 3-4 months, and 5-7 months after transplant. After that, bone marrow samples will be collected once a year, indefinitely. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anaesthetic and a small amount of bone marrow is withdrawn through a large needle. Patients with lymphomas and Hodgkin's disease will need CT scan of the thorax, abdomen, and pelvis performed before transplant and then at 1 month, 3-4 months, and 5-7 months after the transplant. After that it will be done yearly.
This is an investigational study. All treatment drugs are FDA approved and commercially available.
A total of 110 patients may take part in this study. All will be enrolled at MD Anderson.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Double Cord Blood Transplant Group Two Unmanipulated Cord Blood units. Rituxan 375 mg/m2 by vein for patients with CD20 + malignancies. Melphalan 140 mg/m2 by vein on Day -8. Thiotepa 5 mg/Kg by vein on Day -7. Fludarabine 40 mg/m2 by vein on Days -6 to -3. |
Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units.
Other Names:
Drug: Rituxan
375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
Other Names:
Drug: Melphalan
140 mg/m2 by vein on Day -8.
Other Names:
Drug: Thiotepa
5 mg/Kg by vein on Day -7.
Drug: Fludarabine
40 mg/m2 by vein on Days -6 to -3.
Other Names:
|
| Experimental: One Expanded Cord Blood Transplant Group One Unmanipulated and One Expanded Cord Blood Unit. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Cyclophosphamide 50 mg/kg by vein on Day -6. Mesna 10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). Total body irradiation (TBI) given on Day -1 at 2 Gy. |
Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
Other Names:
Drug: Rituxan
375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
Other Names:
Drug: Fludarabine
40 mg/m2 by vein on Days -6 to -3.
Other Names:
Drug: Cyclophosphamide
50 mg/kg by vein on Day -6.
Other Names:
Drug: Mesna
10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
Other Names:
Radiation: Total body irradiation (TBI)
Total body irradiation (TBI) given on Day -1 at 2 Gy.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time To Neutrophil Engraftment [First 100 days, evaluation and blood tests twice weekly]
Engraftment is defined as a sustained ANC > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) >/= 0.5 x 10^9/L.
- Number of Participants With Engraftment [First 100 days, evaluation and blood tests twice weekly]
Engraftment defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC <500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination.
Secondary Outcome Measures
- Rate of Acute Graft Versus Host Disease (GVHD) [Review over first 100 days]
Number of participants who display features of acute GVHD within 100 days of transplant.
- Rate of Chronic GVHD [Up to one year]
Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD.
- Number of Participants Severity of Acute GVHD by Treatment Arm [Following first 100 days, up to one year]
The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Disease-Specific Eligibility Requirements: Patients must have one of the following hematologic malignancies: 1. Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) 2. Acute Lymphoblastic Leukemia (ALL) 3. Chronic Myelogenous Leukemia (CML) 4. Non-Hodgkin's Lymphoma (NHL) 5. Hodgkin's Disease (HD) 6. Chronic Lymphocytic Leukemia (CLL) 7. Chronic eosinophilic leukemia or Philadelphia chromosome negative CML.
-
Greater than 1 month old and <=60 years old for full myeloablative therapy.
-
Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each cord must contain at least 1E7 total nucleated cells/Kg recipient body weight in the pre-thawed fraction.
-
Patient must be willing to undergo bone marrow harvest or peripheral blood progenitor cell (PBPC) collection for use in case of engraftment failure. If the patient is unable or fails to successfully undergo the collection, a family member must be identified to donate hematopoietic stem cells for haploidentical transplant in case of engraftment failure. If autologous hematopoietic stem cells cannot be procured due to marrow contamination by malignancy, or due to harvest failure, and a haploidentical relative is not available or not willing to donate, two cord blood units can be used as the back-up graft.
-
Continuation to Criteria # 4: These units will be identified prior to enrollment in this study.
-
Regimen 1 (Myeloablative mel/thiotepa/fludarabine): 1.Patients with ALL, HD, NHL, AML, MDS, CML, CLL and Chronic eosinophilic leukemia who are candidates for full myeloablative therapy. 2.Performance score of at least 60% by Karnofsky (age >= 12 years), or Lansky Play-Performance Scale (age <12 years). 3.Age >=1 month <=60 years (high-dose).
-
Continuation to Criteria # 6: 4.Adequate major organ system function as demonstrated by:a. Left ventricular ejection function of at least 40%. b.Pulmonary function test demonstrating a diffusion capacity of at least 50%. predicted (high-dose). c.Creatinine < 1.6 mg/dL. d.serum glutamate pyruvate transaminase (SGPT)/bilirubin <= to 2.0 x normal (high-dose).
-
Eligibility for Regimen 2 (Non-myeloablative Cy-Flu-TBI): 1. Patients with ALL, AML, MDS, CML, NHL, CLL, Chronic eosinophilic leukemia and HD who are not candidates for full myeloablative therapy. All patients who received a prior autologous transplant are eligible. 2. Performance score of at least 60% by Karnofsky or PS < 3 (ECOG) (age
= 12 years), or Lansky Play-Performance Scale (age <12 years) 3. Age >= 1 month <=80 years
-
Continuation to Criteria # 8: 4. Left ventricular ejection function of at least 30%;
-
Pulmonary function test demonstrating a diffusion capacity of at least 40% predicted; 6. Creatinine < 3.0 mg/dL; 7. SGPT <= to 4.0 x normal.
-
Regimen 3 (Myeloablative VP16-TBI): 1. Patients with ALL who are candidates for myeloablative therapy, and require a TBI-containing regimen. 2. Performance score of at least 60% by Karnofsky or PS < 2 (ECOG) (age >= 12 years), or Lansky Play-Performance Scale (age <12 years). 3. Age >= 1 month <=50 years. 4. Organ function requirements: a. Left ventricular ejection function of at least 50%. b. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted.
- Creatinine < 1.6 mg/dL. d. SGPT <= 2.0 x normal.
Exclusion Criteria:
-
HIV positive.
-
Pregnancy.
-
Serious medical Condition.
-
Patients with signs & symptoms leading to positive lumbar puncture (malignant cells in the CSF) or to documented metastatic parenchymal disease are ineligible for this study.
-
Availability of appropriate, willing, HLA-matched related donor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 770030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- Cellgenix
Investigators
- Principal Investigator: Simrit Parmar, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ID02-407
- CA061508
- NCI-2012-01299
Study Results
Participant Flow
| Recruitment Details | Recruitment Period: April 10, 2003 to October 3, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center. |
|---|---|
| Pre-assignment Detail | Of the 110 participants registered, five were excluded prior to assignment to groups. |
| Arm/Group Title | Double Cord Blood Transplant Group (Un-Manipulated) | One Expanded Cord Blood Transplant Group (Expanded) |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated Cord Blood (CB) units. Rituxan 375 mg/m2 by vein (IV) Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. Expanded allogeneic cord blood (CB): Transplantation of Two Unmanipulated Cord Blood Units. | One Unmanipulated and One Expanded Cord Blood Unit. Rituxan: 375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Cyclophosphamide 50 mg/kg by vein on Day -6. Mesna 10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). Total body irradiation (TBI) given on Day -1 at 2 Gy. |
| Period Title: Overall Study | ||
| STARTED | 52 | 53 |
| COMPLETED | 45 | 44 |
| NOT COMPLETED | 7 | 9 |
Baseline Characteristics
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm | Total |
|---|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. | Total of all reporting groups |
| Overall Participants | 52 | 53 | 105 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
42
|
44
|
43
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
18
34.6%
|
12
22.6%
|
30
28.6%
|
| Male |
34
65.4%
|
41
77.4%
|
75
71.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
34
65.4%
|
33
62.3%
|
67
63.8%
|
| Not Hispanic or Latino |
8
15.4%
|
10
18.9%
|
18
17.1%
|
| Unknown or Not Reported |
10
19.2%
|
10
18.9%
|
20
19%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
42
80.8%
|
43
81.1%
|
85
81%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
10
19.2%
|
10
18.9%
|
20
19%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
52
100%
|
53
100%
|
105
100%
|
Outcome Measures
| Title | Time To Neutrophil Engraftment |
|---|---|
| Description | Engraftment is defined as a sustained ANC > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) >/= 0.5 x 10^9/L. |
| Time Frame | First 100 days, evaluation and blood tests twice weekly |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. |
| Measure Participants | 52 | 53 |
| Median (Full Range) [Days] |
17
|
15
|
| Title | Number of Participants With Engraftment |
|---|---|
| Description | Engraftment defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC <500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination. |
| Time Frame | First 100 days, evaluation and blood tests twice weekly |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. |
| Measure Participants | 52 | 53 |
| Count of Participants [Participants] |
45
86.5%
|
44
83%
|
| Title | Rate of Acute Graft Versus Host Disease (GVHD) |
|---|---|
| Description | Number of participants who display features of acute GVHD within 100 days of transplant. |
| Time Frame | Review over first 100 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Acute GVHD percentage calculated using engrafted participants only (n=89; expanded 44; un-manipulated 45) |
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. |
| Measure Participants | 45 | 44 |
| Count of Participants [Participants] |
29
55.8%
|
24
45.3%
|
| Title | Rate of Chronic GVHD |
|---|---|
| Description | Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD. |
| Time Frame | Up to one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Chronic GVHD percentage calculated using engrafted patients and alive after 100 days (n=77; expanded 40; unmanipulated 37) |
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. |
| Measure Participants | 37 | 40 |
| Overall Chronic GVHD |
16
30.8%
|
20
37.7%
|
| Limited |
10
19.2%
|
14
26.4%
|
| Extensive |
9
17.3%
|
13
24.5%
|
| Title | Number of Participants Severity of Acute GVHD by Treatment Arm |
|---|---|
| Description | The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. |
| Time Frame | Following first 100 days, up to one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Acute GVHD the analysis was performed on patients with GVHD in the first 100 days. |
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm |
|---|---|---|
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. |
| Measure Participants | 45 | 44 |
| Grade ≤ 2 |
20
38.5%
|
15
28.3%
|
| Grade ≥ 3 |
6
11.5%
|
2
3.8%
|
| No GVHD |
19
36.5%
|
27
50.9%
|
Adverse Events
| Time Frame | Adverse event collection through first 100 days following transplant. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Un-Manipulated CB Arm | Expanded CB Arm | ||
| Arm/Group Description | Transplantation of Two Unmanipulated CB units. Rituxan 375 mg/m2 IV Day -9 for participants with CD20 + malignancies. Melphalan 140 mg/m2 IV on Day -8. Thiotepa 5 mg/Kg IV on Day -7. Fludarabine 40 mg/m2 IV on Days -6 to -3. | Transplantation One Unmanipulated and One Expanded CB Unit. Rituxan: 375 mg/m2 IV on Day - 9 for CD20 + malignancies. Fludarabine 40 mg/m2 IV on Days -6 to -3. Cyclophosphamide 50 mg/kg IV on Day -6. Mesna 10 mg/kg IV before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg). TBI Day -1 at 2 Gy. | ||
All Cause Mortality |
||||
| Un-Manipulated CB Arm | Expanded CB Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Un-Manipulated CB Arm | Expanded CB Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/52 (17.3%) | 4/53 (7.5%) | ||
| Blood and lymphatic system disorders | ||||
| Multi-Organ Failure | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Neutrophils (Absolute Neutrophil Count (ANC)) Decreased | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Hepatobiliary disorders | ||||
| Hepatic Changes (Other: Unknown) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Infections and infestations | ||||
| Infection | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Infection without Neutropenia | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Investigations | ||||
| Bilirubin Increase | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Alanine aminotransferase increased | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Elevevated aspartate aminotransferase (SGOT) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Nervous system disorders | ||||
| Altered Mental State | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Renal and urinary disorders | ||||
| Renal Failure | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Distress Syndrome (ARDS) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Dyspnea | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hemorrhage, Pulmonary | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Pneumonitis | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hypoxia | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Un-Manipulated CB Arm | Expanded CB Arm | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 52/52 (100%) | 53/53 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Blood Bone Marrow hypocellular | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Coagulation (Other, Disseminated intravascular coagulation) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Edema, Facial | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Edema: Head And Neck | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Edema: Limb | 4/52 (7.7%) | 4 | 9/53 (17%) | 9 |
| Lymphatics (Other) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Neutrophils (Absolute Neutrophil Count (ANC)) Decreased | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Cardiac disorders | ||||
| Atrial Fibrillation | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Cardiac General (Other chest pain) | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Hypertension | 8/52 (15.4%) | 8 | 5/53 (9.4%) | 5 |
| Hypotension | 4/52 (7.7%) | 4 | 5/53 (9.4%) | 5 |
| Pain (Chest Wall) | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Palpitations | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Restrictive cardiomyopathy | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Sinus Tachycardia | 6/52 (11.5%) | 6 | 3/53 (5.7%) | 3 |
| Ear and labyrinth disorders | ||||
| Pain (External Ear) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Eye disorders | ||||
| Blurred Vision | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 |
| Cataract | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Dry Eyes | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Ocular/Visual (Other vision change) | 2/52 (3.8%) | 2 | 3/53 (5.7%) | 3 |
| Pain (Eye) | 3/52 (5.8%) | 3 | 0/53 (0%) | 0 |
| Vitreous Hemorrhage | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdomen Distension | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Abdomen Pain | 4/52 (7.7%) | 4 | 5/53 (9.4%) | 5 |
| Ascites | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Colitis | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Constipation | 9/52 (17.3%) | 9 | 4/53 (7.5%) | 4 |
| Diarrhea | 26/52 (50%) | 26 | 26/53 (49.1%) | 26 |
| Distension/Bloating | 3/52 (5.8%) | 3 | 1/53 (1.9%) | 1 |
| Dysphagia | 3/52 (5.8%) | 3 | 5/53 (9.4%) | 5 |
| Epistaxis | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Esophagitis | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 |
| Flatulence | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Gastritis | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Gastrointestinal (other, unknown) | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Heartburn | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 |
| Hematemesis | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Hemorrhage, GI (Lower) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hemorrhoids | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Indigestion | 5/52 (9.6%) | 5 | 5/53 (9.4%) | 5 |
| Mucositis (Clinical exam) | 10/52 (19.2%) | 10 | 12/53 (22.6%) | 12 |
| Nausea | 27/52 (51.9%) | 27 | 27/53 (50.9%) | 27 |
| Nausea Alone | 4/52 (7.7%) | 4 | 6/53 (11.3%) | 6 |
| Pain (Abdomen Nos) | 8/52 (15.4%) | 8 | 8/53 (15.1%) | 8 |
| Pain (Oral Cavity) | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 |
| Rectal Bleeding | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Stomatitis | 8/52 (15.4%) | 8 | 7/53 (13.2%) | 7 |
| Vomiting | 19/52 (36.5%) | 19 | 20/53 (37.7%) | 20 |
| General disorders | ||||
| Constitutional Symptoms (General pain) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Edema | 5/52 (9.6%) | 5 | 2/53 (3.8%) | 2 |
| Fatigue | 23/52 (44.2%) | 23 | 17/53 (32.1%) | 17 |
| Fever Unknown Origin | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hemorrhage (Other) | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 |
| Hemorrhage/Bleeding | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Insomnia | 10/52 (19.2%) | 10 | 9/53 (17%) | 9 |
| Pain (Nos) | 10/52 (19.2%) | 10 | 8/53 (15.1%) | 8 |
| Pain (Other) | 2/52 (3.8%) | 2 | 3/53 (5.7%) | 3 |
| Rigors/Chills | 16/52 (30.8%) | 16 | 12/53 (22.6%) | 12 |
| Hepatobiliary disorders | ||||
| Hepatic (Other: Failure) | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Hepatobiliary/Pancrease | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Jaundice | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Immune system disorders | ||||
| Allergic Reaction | 2/52 (3.8%) | 2 | 5/53 (9.4%) | 5 |
| Allergy/Immunology (Other: allergeric reaction) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Cytokine Release Syndrome | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Graft versus Host Skin | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Graft versus host disease (GVHD), Acute | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Rhinorrhea | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Infections and infestations | ||||
| Febrile Neutropenia | 11/52 (21.2%) | 11 | 11/53 (20.8%) | 11 |
| Fever, Neutropenic | 2/52 (3.8%) | 2 | 5/53 (9.4%) | 5 |
| Fever Without Neutropenia | 8/52 (15.4%) | 8 | 0/53 (0%) | 0 |
| Infection | 7/52 (13.5%) | 7 | 1/53 (1.9%) | 1 |
| Infection (Other) | 6/52 (11.5%) | 6 | 11/53 (20.8%) | 11 |
| Infection Clinical | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Infection Neutropenic | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 |
| Infection With Normal Absolute Neutrophil Count (ANC) | 6/52 (11.5%) | 6 | 8/53 (15.1%) | 8 |
| Infection Without Neutropenia | 1/52 (1.9%) | 1 | 3/53 (5.7%) | 3 |
| Injury, poisoning and procedural complications | ||||
| Bruising | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Bruising (No Thromboysis) | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Burn | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Drug Fever | 13/52 (25%) | 13 | 8/53 (15.1%) | 8 |
| Fever Post-Op | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Investigations | ||||
| Alkaline Phosphate Increase | 5/52 (9.6%) | 5 | 2/53 (3.8%) | 2 |
| Alanine transaminase (ALT) | 6/52 (11.5%) | 6 | 1/53 (1.9%) | 1 |
| Bilirubin Increase | 6/52 (11.5%) | 6 | 6/53 (11.3%) | 6 |
| Creatinine Increased | 7/52 (13.5%) | 7 | 3/53 (5.7%) | 3 |
| Weight Gain | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Weight Loss | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 2/52 (3.8%) | 2 | 6/53 (11.3%) | 6 |
| Cholesterol | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Dehydration | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 |
| Elevevated aspartate aminotransferase (SGOT) | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 |
| Elevevated Lactate dehydrogenase (LDH) | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Hemoglobinuria | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Hypercalcaemia | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hyperglycemia | 7/52 (13.5%) | 7 | 3/53 (5.7%) | 3 |
| Hyperkalemia | 6/52 (11.5%) | 6 | 2/53 (3.8%) | 2 |
| Hypermagnesemia | 3/52 (5.8%) | 3 | 2/53 (3.8%) | 2 |
| Hypernatremia | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Hyperuricemia | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Hypoalbuminemia | 6/52 (11.5%) | 6 | 3/53 (5.7%) | 3 |
| Hypocalcemia | 7/52 (13.5%) | 7 | 5/53 (9.4%) | 5 |
| Hypokalemia | 7/52 (13.5%) | 7 | 5/53 (9.4%) | 5 |
| Hypomagnesemia | 8/52 (15.4%) | 8 | 8/53 (15.1%) | 8 |
| Hyponatremia | 4/52 (7.7%) | 4 | 3/53 (5.7%) | 3 |
| Hypophosphatemia | 2/52 (3.8%) | 2 | 2/53 (3.8%) | 2 |
| Metabolic/Laboratory (Other: Abnormal blood level) | 6/52 (11.5%) | 6 | 6/53 (11.3%) | 6 |
| Proteinuria | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle Weakness | 14/52 (26.9%) | 14 | 8/53 (15.1%) | 8 |
| Muscle Weakness (Whole body/generalized) | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 |
| Musculoskeletal (Other general pain) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Pain (Back) | 13/52 (25%) | 13 | 4/53 (7.5%) | 4 |
| Pain (Bone) | 4/52 (7.7%) | 4 | 4/53 (7.5%) | 4 |
| Pain (Buttock) | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Pain (Extremity-Limb) | 3/52 (5.8%) | 3 | 6/53 (11.3%) | 6 |
| Pain (Joint) | 5/52 (9.6%) | 5 | 3/53 (5.7%) | 3 |
| Pain (Muscle) | 4/52 (7.7%) | 4 | 3/53 (5.7%) | 3 |
| Pain (Neck) | 4/52 (7.7%) | 4 | 3/53 (5.7%) | 3 |
| Nervous system disorders | ||||
| Extrapyramidal | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Headache | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Involuntary Movement | 1/52 (1.9%) | 1 | 3/53 (5.7%) | 3 |
| Mood Alteration (Agitation) | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Mood Alteration (Anxiety) | 16/52 (30.8%) | 16 | 14/53 (26.4%) | 14 |
| Mood Alteration (Depression) | 4/52 (7.7%) | 4 | 2/53 (3.8%) | 2 |
| Neurology (Other) | 3/52 (5.8%) | 3 | 6/53 (11.3%) | 6 |
| Neuropathy: Sensory | 3/52 (5.8%) | 3 | 2/53 (3.8%) | 2 |
| Pain (Head/Headache) | 13/52 (25%) | 13 | 16/53 (30.2%) | 16 |
| Pain Neuropathic | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Psychosis | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Somnolence | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Tremors | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 |
| Psychiatric disorders | ||||
| Altered Mental State | 1/52 (1.9%) | 1 | 3/53 (5.7%) | 3 |
| Anxiety | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Confusion | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Dizziness | 9/52 (17.3%) | 9 | 4/53 (7.5%) | 4 |
| Renal and urinary disorders | ||||
| Bladder Spasms | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Blood urea nitrogen (BUN) Increase | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Cystitis | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Dysuria | 6/52 (11.5%) | 6 | 1/53 (1.9%) | 1 |
| Hematuria | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Incontinence, Urinary | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Pain (Bladder) | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Renal Failure | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Renal/Genitourinary (Other: out change) | 4/52 (7.7%) | 4 | 2/53 (3.8%) | 2 |
| Urinary Frequency | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Urinary Tract Infection | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Hot Flashes | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Pain (Penis) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Pain (Scrotum) | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Vaginal Bleeding | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Vaginitis | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic Rhinitis | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Acute Respiratory Distress Syndrome (ARDS) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Bronchospasm | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Cough | 12/52 (23.1%) | 12 | 6/53 (11.3%) | 6 |
| Dyspnea | 11/52 (21.2%) | 11 | 11/53 (20.8%) | 11 |
| Hemoptysis | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Hemorrhage, Pulmonary | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hemorrhage, Pulmonary | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Hiccoughs | 3/52 (5.8%) | 3 | 2/53 (3.8%) | 2 |
| Hypoxia | 1/52 (1.9%) | 1 | 2/53 (3.8%) | 2 |
| Nasal/Paranasal Sinus Reactions | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Pain (Chest/Thorax) | 0/52 (0%) | 0 | 2/53 (3.8%) | 2 |
| Pain (Throat/Pharynx) | 2/52 (3.8%) | 2 | 7/53 (13.2%) | 7 |
| Pleural Effusion | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Pneumonitis | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Pulmonary (Other: infection) | 3/52 (5.8%) | 3 | 3/53 (5.7%) | 3 |
| Respiratory Symptoms | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Voice Changes | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Alopecia | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Decubitus Ulcer | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Dermatology/Skin (irritation) | 4/52 (7.7%) | 4 | 6/53 (11.3%) | 6 |
| Erythema Multiforme | 9/52 (17.3%) | 9 | 6/53 (11.3%) | 6 |
| Facial Flushing | 2/52 (3.8%) | 2 | 0/53 (0%) | 0 |
| Flushing | 1/52 (1.9%) | 1 | 1/53 (1.9%) | 1 |
| Hematoma | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Hyperpigmentation | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Pain (Skin) | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Petechiae | 5/52 (9.6%) | 5 | 3/53 (5.7%) | 3 |
| Pruritus | 5/52 (9.6%) | 5 | 3/53 (5.7%) | 3 |
| Pruritus/Itching | 16/52 (30.8%) | 16 | 8/53 (15.1%) | 8 |
| Rash Erythema Mult | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
| Rash/Desquamation | 7/52 (13.5%) | 7 | 10/53 (18.9%) | 10 |
| Sweating | 0/52 (0%) | 0 | 1/53 (1.9%) | 1 |
| Urticaria | 2/52 (3.8%) | 2 | 1/53 (1.9%) | 1 |
| Vascular disorders | ||||
| Thrombosis/Embolism | 1/52 (1.9%) | 1 | 0/53 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Simrit Parmar, MD/Associate Professor, Stem Cell Transplantation |
|---|---|
| Organization | UT MD Anderson Cancer Center |
| Phone | 713-792-7734 |
| SParmar@mdanderson.org |
- ID02-407
- CA061508
- NCI-2012-01299