Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00822770
Collaborator
Genzyme, a Sanofi Company (Industry)
47
Enrollment
1
Location
2
Arms
45
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).

Condition or DiseaseIntervention/TreatmentPhase
Phase 1/Phase 2

Detailed Description

The Study Treatment:

Fludarabine is a chemotherapy drug that is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.

Busulfan is a chemotherapy drug that is designed to bind to DNA, which may cause cancer cells to die. It is commonly used in stem cell transplants.

Plerixafor and filgrastim are designed to cause cancer cells to move from the bone marrow into the blood stream. This may help to make the cancer cells more sensitive to being killed by the chemotherapy.

An "allogeneic" (from a donor) stem cell transplant is designed to help the recipient's body attack the cancer cells that may remain in the body after chemotherapy.

Study Groups and Plerixafor Dose Levels:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 4 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 48 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of plerixafor you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of plerixafor. Each new group will receive a higher dose of plerixafor than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of plerixafor is found.

If you are enrolled in Phase II, you will receive plerixafor at the highest dose that was tolerated in the Phase I portion.

In this study, plerixafor is the only study drug where different dose levels are being tested and compared.

Drug Administration Before the Transplant:

You will receive your first dose of filgrastim on Day -9. (Day -9 means 9 days before the stem cell transplant, which will occur on Day 0).

Filgrastim is injected under the skin once a day from Day -9 through Day -4. Plerixafor is injected under the skin once a day from Day -7 through Day -4. The plerixafor injections will occur 8 hours before the fludarabine and busulfan chemotherapy.

The fludarabine and busulfan will be given by vein through a central venous catheter (CVC). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.

Fludarabine is given once a day from Day -6 through Day -3, over 1 hour each time. On these same days, busulfan will be given after the fludarabine, over 3 hours.

You will also receive tacrolimus in order to lower the risk of graft vs. host disease (GVHD). GVHD is a disease that occurs when the donor's immune cells react against the recipient's body, attacking the recipient's cells and tissues.

Starting on Day -2, tacrolimus will be given as a continuous (non-stop) infusion through the CVC. When the study doctor decides it seems safe, you will begin taking tacrolimus by mouth instead, for as long as the study doctor decides is necessary.

If your stem cell donor is not someone who is related to you, you will receive antithymocyte globulin (ATG) through the CVC once a day from Day -3 through Day -1. On Day -3, it will be given over at least 6 hours. On Days -2 and -1, it will be given over at least 4 hours. This drug is given in order to weaken your immune system in order to lower the risk of your immune system rejecting the transplanted cells.

Blood Tests Before the Transplant:

If you are in the Phase I part of this study, the following blood samples will be drawn and are not optional. Eight total blood samples (about 1 1/2 teaspoons each) will be drawn daily with your routine morning labs beginning before your first dose of study therapy (or Day -9) through Day -3. These samples will be used for research purposes, to study how the chemotherapy drugs and transplant may affect your normal cells and cancerous cells.

If you are in the Phase II part of the study the following blood samples are optional and if you agree, eight total blood samples (about 1 1/2 teaspoons each) will be drawn daily beginning before your first dose of study therapy (or Day -9) through Day -3. These samples will be used for research purposes, to study how the chemotherapy drugs and transplant may affect your normal cells and cancerous cells.

Stem Cell Transplant:

On Day 0, after 2 days of rest from chemotherapy, the donor's stem cells will be given to you by vein (through the CVC). This should take about 30-60 minutes.

Drug Administration After the Transplant:

In addition to continuing to receive tacrolimus to lower the risk of GVHD (as described above), after the transplant you will also receive methotrexate to lower the risk of GVHD. Methotrexate will be given by vein, through the CVC, over 15 minutes on Days 1, 3, and 6. It will also be given on Day 11 if your stem cell donor is someone who is not related to you.

Once a day, starting at 1 week after the transplant, you will receive filgrastim as an injection under your skin. These daily injections will continue until your blood counts recover.

Reasons for Stopping the Study Treatment Early:

If you experience intolerable side effects or the disease gets worse during study treatment, you will be taken off the study treatment.

Other Procedures After the Transplant:

You will remain in the hospital until your blood counts recover (usually about 4 weeks after the transplant). You will continue being monitored for any infections and transplant-related side effects for at least 100 days after the transplant.

At 1, 3, 6, and 12 months after the transplant, you will have blood tests (about 3 tablespoons) and bone marrow biopsies performed to check the status of the disease.

Length of Study Participation:

Your active participation in this study will be over at 12 months after the transplant. The study staff will continue to contact your local doctor regularly from then on. The purpose is to check the status of the disease and see how you are doing.

Up to 72 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson.

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: Phase I

ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

Drug: Plerixafor
Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses. Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I
Other Names:
  • AMD3100
  • Drug: Filgrastim
    Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
    Other Names:
  • G-CSF
  • Neupogen
  • Drug: Fludarabine
    Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
    Other Names:
  • Fludarabine Phosphate
  • Fludara
  • Drug: Busulfan
    Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
    Other Names:
  • Busulfex™
  • Myleran®
  • Procedure: Allogeneic blood stem cell transplant
    Stem Cell Infusion (Bone marrow or PBPC)
    Other Names:
  • Bone Marrow Transplantation
  • Blood Stem Cell Transplantation
  • Drug: ATG (Thymoglobulin)
    Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
    Other Names:
  • Antithymocyte globulin
  • Experimental: Phase II

    ATG + MTD Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant

    Drug: Plerixafor
    Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses. Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I
    Other Names:
  • AMD3100
  • Drug: Filgrastim
    Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
    Other Names:
  • G-CSF
  • Neupogen
  • Drug: Fludarabine
    Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
    Other Names:
  • Fludarabine Phosphate
  • Fludara
  • Drug: Busulfan
    Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
    Other Names:
  • Busulfex™
  • Myleran®
  • Procedure: Allogeneic blood stem cell transplant
    Stem Cell Infusion (Bone marrow or PBPC)
    Other Names:
  • Bone Marrow Transplantation
  • Blood Stem Cell Transplantation
  • Drug: ATG (Thymoglobulin)
    Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.
    Other Names:
  • Antithymocyte globulin
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor [28 day cycle (Plerixafor Day -7 to Day -4)]

      Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).

    Secondary Outcome Measures

    1. Number of Participants Alive With no Disease Progression at Time of Allo Transplant [Baseline till transplant, Day -9 to Day 0, to 10 days]

      In Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0.

    2. Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30 [30 Days post engraftment]

      Number of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients age >/=18 to </= 65 years.

    2. Diagnosis of AML in first or greater remission, first or subsequent relapse, or primary induction failure; MDS with intermediate or high risk International Prognostic Scoring System (IPSS) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; AML arising from MDS; or CML which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had

    5% blasts in the blood or bone marrow. Patients receiving second transplants after relapse are considered in the relapse group.

    1. White Blood Count (CBC) </= 20 * 10^9/l.

    2. Patients should have a histocompatible, related or unrelated volunteer donor available. A histocompatible donor is defined as HLA matched related donor or an unrelated donor matched for HLA- A, B, C, and DR antigens by high-resolution DNA techniques.

    3. Zubrod performance status 0 or 1, or Karnofsky performance status 90-100%.

    4. Left ventricular ejection fraction >/= 45 %. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.

    5. No symptomatic pulmonary disease. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC) and diffusion capacity of carbon monoxide (DLCO) >/= 50 % of expected, corrected for hemoglobin.

    6. Serum creatinine </=1.5 mg/dl.

    7. Serum glutamic pyruvic transaminase (SGPT) </= 200 IU/ml unless related to the malignancy.

    8. Total serum bilirubin </=1.5 mg/dl (unless Gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (ULN).

    9. Patient or patient's legal representative able to sign informed consent.

    Exclusion Criteria:
    1. History of HIV positive.

    2. Positive Beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.

    3. Pleural/pericardial effusion or ascites estimated >/= 1 liter.

    4. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.

    5. History of acute hepatitis, chronic active hepatitis or cirrhosis.

    6. Patients with class 3 or 4 angina (New York Heart Association (NYHA) criteria).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UT MD Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • Genzyme, a Sanofi Company

    Investigators

    • Principal Investigator: Marina Konopleva, MD, PhD, UT MD Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00822770
    Other Study ID Numbers:
    • 2007-0772
    First Posted:
    Jan 14, 2009
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Sep 1, 2020

    Study Results

    Participant Flow

    Recruitment DetailsRecruitment Period: January 2, 2009 to February 1, 2012. All recruitment done at the University of Texas MD Anderson Cancer Center.
    Pre-assignment Detail
    Arm/Group TitlePhase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSF
    Arm/Group DescriptionPlerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
    Period Title: Overall Study
    STARTED1829
    COMPLETED1528
    NOT COMPLETED31

    Baseline Characteristics

    Arm/Group TitlePhase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSFTotal
    Arm/Group DescriptionPlerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.Total of all reporting groups
    Overall Participants182947
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    58
    53
    55
    Sex: Female, Male (Count of Participants)
    Female
    9
    50%
    17
    58.6%
    26
    55.3%
    Male
    9
    50%
    12
    41.4%
    21
    44.7%
    Region of Enrollment (participants) [Number]
    United States
    18
    100%
    29
    100%
    47
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor
    DescriptionPhase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).
    Time Frame28 day cycle (Plerixafor Day -7 to Day -4)

    Outcome Measure Data

    Analysis Population Description
    Two participants of 18 registered left the study without receiving Plerixafor treatment and there were not available for MTD analysis.
    Arm/Group TitlePhase I Plerixafor + G-CSF
    Arm/Group DescriptionATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC) Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days. Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days. ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors. Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine. Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
    Measure Participants16
    0 mcg/kg daily
    1
    5.6%
    80 mcg/kg daily
    4
    22.2%
    160 mcg/kg daily
    7
    38.9%
    240 mcg/kg daily
    4
    22.2%
    2. Secondary Outcome
    TitleNumber of Participants Alive With no Disease Progression at Time of Allo Transplant
    DescriptionIn Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0.
    Time FrameBaseline till transplant, Day -9 to Day 0, to 10 days

    Outcome Measure Data

    Analysis Population Description
    Participants treated in the Phase 1 portion of the trial at the selected MTD dose were counted toward the maximum subgroup sample in Phase 2, therefore four of Phase I participants were included having received the MTD Plerixafor dose; however, one late participant in Phase 2 was not evaluable for the outcome.
    Arm/Group TitleOverall Study: Plerixafor + G-CSF
    Arm/Group DescriptionPlerixafor escalating doses 0, 80, 160, 240 mcg/kg or MTD 240 mcg/kg given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)
    Measure Participants32
    Participants in
    16
    88.9%
    Participants not in Complete Remission
    16
    88.9%
    3. Secondary Outcome
    TitleEngraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30
    DescriptionNumber of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.
    Time Frame30 Days post engraftment

    Outcome Measure Data

    Analysis Population Description
    There were 39 participants receiving first transplants for acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) of both Phase I and Phase II who received MTD dose and allo transplant thus were evaluable for outcome.
    Arm/Group TitleOverall Study: Plerixafor + G-CSF
    Arm/Group DescriptionPlerixafor escalating doses 0, 80, 160, 240 mcg/kg or MTD 240 mcg/kg given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)
    Measure Participants39
    Count of Participants [Participants]
    32
    177.8%

    Adverse Events

    Time FrameThe active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
    Adverse Event Reporting Description
    Arm/Group TitlePhase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSF
    Arm/Group DescriptionATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant: Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; & 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
    All Cause Mortality
    Phase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSF
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    Phase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSF
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total8/18 (44.4%) 6/29 (20.7%)
    General disorders
    Death1/18 (5.6%) 11/29 (3.4%) 1
    Infections and infestations
    Neutropenic fever1/18 (5.6%) 10/29 (0%) 0
    Infection3/18 (16.7%) 44/29 (13.8%) 4
    Musculoskeletal and connective tissue disorders
    Fall1/18 (5.6%) 20/29 (0%) 0
    Nervous system disorders
    Central Nervous System (CNS) hemorrhage0/18 (0%) 01/29 (3.4%) 1
    Renal and urinary disorders
    Hemorrhagic cyctitis1/18 (5.6%) 10/29 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure1/18 (5.6%) 10/29 (0%) 0
    Pneumonia1/18 (5.6%) 10/29 (0%) 0
    Skin and subcutaneous tissue disorders
    Graft versus Host Disease, Skin Rash1/18 (5.6%) 12/29 (6.9%) 2
    Other (Not Including Serious) Adverse Events
    Phase I Plerixafor + G-CSFPhase II Plerixafor 240 mcg/kg + G-CSF
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total17/18 (94.4%) 29/29 (100%)
    Blood and lymphatic system disorders
    Elevated White Blood Count8/18 (44.4%) 811/29 (37.9%) 12
    Cardiac disorders
    High Blood Pressure5/18 (27.8%) 64/29 (13.8%) 4
    Change in cardiac function1/18 (5.6%) 10/29 (0%) 0
    Gastrointestinal disorders
    Gastrointestinal disorders9/18 (50%) 255/29 (17.2%) 5
    Nausea7/18 (38.9%) 915/29 (51.7%) 16
    Dysphagia8/18 (44.4%) 914/29 (48.3%) 14
    Diarrhea5/18 (27.8%) 56/29 (20.7%) 6
    General disorders
    Flu-like Symptoms12/18 (66.7%) 1715/29 (51.7%) 15
    Infections and infestations
    Infections16/18 (88.9%) 3611/29 (37.9%) 17
    Injury, poisoning and procedural complications
    Graft versus Host Disease4/18 (22.2%) 41/29 (3.4%) 1
    Investigations
    Alkaline phosphatase Increase14/18 (77.8%) 144/29 (13.8%) 4
    Alanine aminotransferase increased0/18 (0%) 02/29 (6.9%) 2
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders: Changes within blood level3/18 (16.7%) 30/29 (0%) 0
    Musculoskeletal and connective tissue disorders
    Bone Pain6/18 (33.3%) 72/29 (6.9%) 2
    Nervous system disorders
    Nervous system disorders8/18 (44.4%) 103/29 (10.3%) 3
    Renal and urinary disorders
    Urinary changes1/18 (5.6%) 10/29 (0%) 0
    Hemoglobinuria1/18 (5.6%) 13/29 (10.3%) 3
    Genitourinary disorders5/18 (27.8%) 62/29 (6.9%) 2
    Respiratory, thoracic and mediastinal disorders
    Respiratory Infection, Pneumonitis2/18 (11.1%) 21/29 (3.4%) 1
    Skin and subcutaneous tissue disorders
    Skin rash9/18 (50%) 1610/29 (34.5%) 13

    Limitations/Caveats

    [Not Specified]

    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/TitleMarina Konopleva, MD, PhD / Associate Professor
    OrganizationThe University of Texas (UT) MD Anderson Cancer Center
    Phone713-794-1628
    Emailmkonople@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00822770
    Other Study ID Numbers:
    • 2007-0772
    First Posted:
    Jan 14, 2009
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Sep 1, 2020