Stem Cell TransplantationPhase 1/2NCT00822770
Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin
A Phase 1/2 study testing Plerixafor, Filgrastim and Fludarabine in people with Stem Cell Transplantation and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stem Cell Transplantation, Leukemia
- What is being tested?
- Plerixafor, Filgrastim and Fludarabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age >/=18 to </= 65 years.
- 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.
- White Blood Count (CBC) </= 20 * 10^9/l.
- 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.
- Zubrod performance status 0 or 1, or Karnofsky performance status 90-100%.
- Left ventricular ejection fraction >/= 45 %. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
Show all 11Show fewer
- 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.
- Serum creatinine </=1.5 mg/dl.
- Serum glutamic pyruvic transaminase (SGPT) </= 200 IU/ml unless related to the malignancy.
- Total serum bilirubin </=1.5 mg/dl (unless Gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (ULN).
- Patient or patient's legal representative able to sign informed consent.
Who cannot join
- History of HIV positive.
- 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.
- Pleural/pericardial effusion or ascites estimated >/= 1 liter.
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- History of acute hepatitis, chronic active hepatitis or cirrhosis.
- Patients with class 3 or 4 angina (New York Heart Association (NYHA) criteria).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias
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).
Read the 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.
- Conditions
- Stem Cell Transplantation, Leukemia
- Being tested
- Plerixafor, Filgrastim, Fludarabine, Busulfan, Allogeneic blood stem cell transplant
- Keywords
- Blood Stem Cell Transplantation, Bone Marrow Transplantation, Bone Marrow Cell Transplantation, Stem Cell Transplantation, Allogeneic Hematopoietic Transplantation, Advanced Myeloid Leukemia, Acute Myeloid Leukemia, AML, Myelodysplastic syndrome, MDS, Chronic Myeloid Leukemia, CML, Graft Versus Host Disease, GVHD, ATG, Busulfan, Busulfex™, Myleran®, Filgrastim, Neupogen
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called AMD3100
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
FilgrastimDrug
Also called G-CSF, Neupogen
Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.
BusulfanDrug
Also called Busulfex™, Myleran®
Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.
Allogeneic blood stem cell transplantProcedure or surgery
Also called Bone Marrow Transplantation, Blood Stem Cell Transplantation
Stem Cell Infusion (Bone marrow or PBPC)
ATG (Thymoglobulin)Drug
Also called Antithymocyte globulin
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Receives: Drug: Plerixafor; Drug: Filgrastim; Drug: Fludarabine; Drug: Busulfan; Procedure: Allogeneic blood stem cell transplant; Drug: ATG (Thymoglobulin) |
| Phase II | Experimental | ATG + MTD Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Receives: Drug: Plerixafor; Drug: Filgrastim; Drug: Fludarabine; Drug: Busulfan; Procedure: Allogeneic blood stem cell transplant; Drug: ATG (Thymoglobulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor
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).
Measured: 28 day cycle (Plerixafor Day -7 to Day -4)
Secondary outcomes (2)
Number of Participants Alive With no Disease Progression at Time of Allo Transplant
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.
Measured: Baseline till transplant, Day -9 to Day 0, to 10 days
Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30
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.
Measured: 30 Days post engraftment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Marina Konopleva, MD, PhD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822770
- Sponsor's protocol ID
- 2007-0772
- Status last verified
- Sep 2020
- First submitted
- 13 Jan 2009
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias
- ClinicalTrials.gov ID
- NCT00822770
- Acronym / sponsor ID
- 2007-0772
- Conditions
- Stem Cell Transplantation, Leukemia
- Keywords
- Blood Stem Cell Transplantation, Bone Marrow Transplantation, Bone Marrow Cell Transplantation, Stem Cell Transplantation, Allogeneic Hematopoietic Transplantation, Advanced Myeloid Leukemia, Acute Myeloid Leukemia, AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Jan 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: Plerixafor, Drug: Filgrastim, Drug: Fludarabine, Drug: Busulfan, Procedure: Allogeneic blood stem cell transplant, Drug: ATG (Thymoglobulin)ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant |
| Phase II | Experimental | Drug: Plerixafor, Drug: Filgrastim, Drug: Fludarabine, Drug: Busulfan, Procedure: Allogeneic blood stem cell transplant, Drug: ATG (Thymoglobulin)ATG + MTD Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients age >/=18 to </= 65 years.
- 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.
- White Blood Count (CBC) </= 20 * 10^9/l.
- 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.
- Zubrod performance status 0 or 1, or Karnofsky performance status 90-100%.
Key exclusion criteria (6 listed)
- History of HIV positive.
- 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.
- Pleural/pericardial effusion or ascites estimated >/= 1 liter.
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- History of acute hepatitis, chronic active hepatitis or cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlerixaforAlso: AMD3100Phase 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 | Drug | Phase I, Phase II |
| FilgrastimAlso: G-CSF, NeupogenDose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days. | Drug | Phase I, Phase II |
| FludarabineAlso: Fludarabine Phosphate, FludaraDose of 40 mg/m^2 beginning on Day -6 for four consecutive days. | Drug | Phase I, Phase II |
| BusulfanAlso: Busulfex™, Myleran®Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine. | Drug | Phase I, Phase II |
| Allogeneic blood stem cell transplantAlso: Bone Marrow Transplantation, Blood Stem Cell TransplantationStem Cell Infusion (Bone marrow or PBPC) | Procedure or surgery | Phase I, Phase II |
| ATG (Thymoglobulin)Also: Antithymocyte globulinDose(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. | Drug | Phase I, Phase II |
Primary outcome
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor
Time frame: 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).
2 secondary outcomes
Number of Participants Alive With no Disease Progression at Time of Allo Transplant
Time frame: Baseline till transplant, Day -9 to Day 0, to 10 days
Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30
Time frame: 30 Days post engraftment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Konopleva, MD, PhD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plerixafor, Filgrastim and Fludarabine in people with Stem Cell Transplantation and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor (time frame: 28 day cycle (Plerixafor Day -7 to Day -4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.