Hematologic NeoplasmsPhase 2NCT00914849
Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
A Phase 2 study testing AMD3100, Leukopheresis and Stem cell transplant in people with Hematologic Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- AMD3100, Leukopheresis and Stem cell transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2012
- Phase
- Phase 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
- Donor Eligibility
- Donor is 18 to 70 years of age inclusive.
- If female and of child-bearing age: must be non-pregnant, not breast feeding and agree to use adequate contraception.
- Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
- Donor must be willing to provide written informed consent.
- Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
Show all 42Show fewer
- Adequate renal function as defined by a calculated serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
- Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
- Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
- Donor must be HIV-1\&2 antibody and HTLV-I\&II antibody sero-negative, by Food and Drug Administration (FDA) licensed test.
- Donor must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Donor must demonstrate ability to be compliant with study regimen.
- Donor must not have an active infection at the time of study entry.
- Donor does not have active alcohol or substance abuse within 6 months of study entry.
- Donor is not currently enrolled on another investigational agent study.
- Donor does not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.
- Recipient Eligibility
- Recipient must have available the successful collection of an AMD3100 mobilized product. When an adequate collection cannot be obtained using G-CSF, some recipients may need to receive a combined product of mobilized cells with AMD3100 and g granulocyte-colony stimulating factor (G-CSF). Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after two days of IV AMD3100 will not be considered "eligible" but followed per protocol for safety purposes only.
- Patient is 18 to 65 years of age inclusive.
- Patient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
- Patient must provide signed informed consent.
- If female and of child-bearing age: must be non-pregnant, not breast feeding, and uses adequate contraception.
- Patient must have one of the following diagnoses:
- Acute myelogenous leukemia (AML) in 1st or subsequent remission or in relapse,
- Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission or in relapse,
- Myelodysplastic syndrome either intermediate 1 or 2, or high risk by the International Prognostic Scoring System,
- Chronic myelogenous leukemia (CML) in accelerated or second chronic phase,
- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or refractory relapse,
- Chronic lymphocytic leukemia (CLL), Rai Stage 2-4, failing at least 2 prior regimens, OR
- Multiple myeloma (MM), Stage 2-3.
- Adequate cardiac function with a left ventricular ejection fraction ≥ 40%.
- Adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50% of predicted and a DLCO ≥40% of predicted, corrected for hemoglobin.
- Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation).
- Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
- Adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system (CNS) tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain.
- No evidence of active infection at the time of the transplant preparative regimen or at time of transplantation.
- Patient must be HIV-1\&2 antibody and HTLV-I \& II antibody sero-negative, by FDA licensed test.
- Patient has an ECOG performance status of 0 or 1.
- Patient must demonstrate ability to be compliant with medical regimen.
- Patient must not have active alcohol or substance abuse within 6 months of study entry.
- Patient must not be enrolled on another investigational agent concurrently.
- Patient must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient.
Who cannot join
- See Inclusion criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase II Study Evaluating the Safety and Efficacy of Intravenous AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.
Read the detailed description
- To reduce the number of donors treated with intravenous (IV) AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplantation when compared to our historic group who received 240ug SC AMD3100 from 33% (8 in 24) to 11% (3 in 27).
- To estimate with 95% confidence intervals the proportion of human leukocyte antigen (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following one or two intravenous infusions.
- To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and to determine if peripheral blood stem cell products collected after mobilization with IV AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched recipients as measured by neutrophil engraftment by day +21.
- To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation.
- To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells.
- Conditions
- Hematologic Neoplasms
- Being tested
- AMD3100, Leukopheresis, Stem cell transplant
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMD3100Drug
Also called Mozobil, Plerixafor
LeukopheresisProcedure or surgery
Stem cell transplantProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Donor | Experimental | * Day 1
* AMD3100 320 ug/kg IV
* Leukopheresis
* Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)
* AMD3100 320 ug/kg IV
* Leukopheresis Receives: Drug: AMD3100; Procedure: Leukopheresis |
| Arm 2 - Recipient | Experimental | Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM
Day 0 = Stem Cell Transplant Receives: Procedure: Stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant
Measured: Completion of enrollment of all donors (17 months)
Secondary outcomes (13)
Number of Donors Who Experience Grade 3-4 Infusional Toxicity
Measured: Up to Day 2
Number of Recipients Who Have Neutrophil Engraftment
Measured: Day 21
Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)
-Blood samples for pharmacokinetics were drawn on the following schedule:
- prior to IV infusion
- 15 minutes after start of infusion
- 30 minutes after start of infusion
- 1 hour after start of infusion
- 4 hours after start of infusion
- 6 hours after start of infusion
- 9 hours after start of infusion
- 24 hours after start of infusion
Measured: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Half Life
-Blood samples for pharmacokinetics were drawn on the following schedule:
- prior to IV infusion
- 15 minutes after start of infusion
- 30 minutes after start of infusion
- 1 hour after start of infusion
- 4 hours after start of infusion
- 6 hours after start of infusion
- 9 hours after start of infusion
- 24 hours after start of infusion
Measured: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)
Measured: Day 1 and Day 2
Rate of Acute GVHD (Grade II-IV) in Recipients
Measured: Day 0-Day 100 (acute)
Rate of Acute GVHD (Grade III-IV) in Recipients
Measured: Day 0-Day 100 (acute)
Time to Neutrophil Engraftment for Recipients
Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.
Measured: Up through Day 100
Time to Platelet Engraftment for Recipients
Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.
Measured: Up to Day 100
Transplant Related Mortality Rate for Recipients
Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.
Measured: Day 100
Grade 3-4 Toxicity for Recipients
Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.
Measured: 1 year
Rate of Chronic GVHD in Recipients
Measured: Day 101-1 year
Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionFeb 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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John DiPersio, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914849
- Sponsor's protocol ID
- 09-0713 / 201103429
- Status last verified
- Apr 2017
- First submitted
- 1 Jun 2009
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Levesque JP, Hendy J, Takamatsu Y, Simmons PJ, Bendall LJ. Disruption of the CXCR4/CXCL12 chemotactic interaction during hematopoietic stem cell mobilization induced by GCSF or cyclophosphamide. J Clin Invest. 2003 Jan;111(2):187-96. doi: 10.1172/JCI15994.
PubMed 12531874Peled A, Petit I, Kollet O, Magid M, Ponomaryov T, Byk T, Nagler A, Ben-Hur H, Many A, Shultz L, Lider O, Alon R, Zipori D, Lapidot T. Dependence of human stem cell engraftment and repopulation of NOD/SCID mice on CXCR4. Science. 1999 Feb 5;283(5403):845-8. doi: 10.1126/science.283.5403.845.
PubMed 9933168Broxmeyer HE, Hangoc G, Cooper S, Bridger G. Interference of the SDF-1/CXCR4 axis in mice with AMD3100 induces rapid high level mobilization of hematopoietic progenitor cells, and AMD3100 acts synergistically with G-CSF and MIP-1 alpha to mobilize progenitors. Blood. 2001;96:3371a
Broxmeyer HE, Hangoc G, Cooper S, Li X, Bridger G, Clapp DW. AMD3100, an antagonist of CXCR4 and mobilizer of myeloid progenitor cells, is a potent mobilizer of competitive repopulating long term marrow self renewing stem cells in mice. Blood. 2002;98:2397a
Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15;102(8):2728-30. doi: 10.1182/blood-2003-02-0663. Epub 2003 Jul 10.
PubMed 12855591Devine S, Adkins D, Khoury H, Vij R, Goodnough LT, Graubert T, Tomasson M, Blum W, DiPersio J, Brown R. Mobilization of donors with GM-CSF plus G-CSF or GM-CSF alone results in significantly different graft composition compared to G-CSF alone. Blood. 2002;100:825a
Devine SM, Vij R, Rettig M, Todt L, McGlauchlen K, Fisher N, Devine H, Link DC, Calandra G, Bridger G, Westervelt P, Dipersio JF. Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction. Blood. 2008 Aug 15;112(4):990-8. doi: 10.1182/blood-2007-12-130179. Epub 2008 Apr 21.
PubMed 18426988Broxmeyer HE, Orschell CM, Clapp DW, Hangoc G, Cooper S, Plett PA, Liles WC, Li X, Graham-Evans B, Campbell TB, Calandra G, Bridger G, Dale DC, Srour EF. Rapid mobilization of murine and human hematopoietic stem and progenitor cells with AMD3100, a CXCR4 antagonist. J Exp Med. 2005 Apr 18;201(8):1307-18. doi: 10.1084/jem.20041385.
PubMed 15837815Hess DA, Bonde J, Craft TP, Wirthlin L, Hohm S, Lahey R, Todt LM, Dipersio JF, Devine SM, Nolta JA. Human progenitor cells rapidly mobilized by AMD3100 repopulate NOD/SCID mice with increased frequency in comparison to cells from the same donor mobilized by granulocyte colony stimulating factor. Biol Blood Marrow Transplant. 2007 Apr;13(4):398-411. doi: 10.1016/j.bbmt.2006.12.445.
PubMed 17382247Schroeder MA, Rettig MP, Lopez S, Christ S, Fiala M, Eades W, Mir FA, Shao J, McFarland K, Trinkaus K, Shannon W, Deych E, Yu J, Vij R, Stockerl-Goldstein K, Cashen AF, Uy GL, Abboud CN, Westervelt P, DiPersio JF. Mobilization of allogeneic peripheral blood stem cell donors with intravenous plerixafor mobilizes a unique graft. Blood. 2017 May 11;129(19):2680-2692. doi: 10.1182/blood-2016-09-739722. Epub 2017 Mar 14.
PubMed 28292947
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Safety and Efficacy of Intravenous AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
- ClinicalTrials.gov ID
- NCT00914849
- Acronym / sponsor ID
- 09-0713 / 201103429
- Conditions
- Hematologic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.
Detailed description
- To reduce the number of donors treated with intravenous (IV) AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplantation when compared to our historic group who received 240ug SC AMD3100 from 33% (8 in 24) to 11% (3 in 27).
- To estimate with 95% confidence intervals the proportion of human leukocyte antigen (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following one or two intravenous infusions.
- To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and to determine if peripheral blood stem cell products collected after mobilization with IV AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched recipients as measured by neutrophil engraftment by day +21.
- To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation.
- To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Donor | Experimental | Drug: AMD3100, Procedure: Leukopheresis* Day 1 * AMD3100 320 ug/kg IV * Leukopheresis * Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient) * AMD3100 320 ug/kg IV * Leukopheresis |
| Arm 2 - Recipient | Experimental | Procedure: Stem cell transplantStandard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM Day 0 = 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 (42 listed)
- Donor Eligibility
- Donor is 18 to 70 years of age inclusive.
- If female and of child-bearing age: must be non-pregnant, not breast feeding and agree to use adequate contraception.
- Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
- Donor must be willing to provide written informed consent.
Key exclusion criteria (1 listed)
- See Inclusion criteria above
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 |
|---|---|---|
| AMD3100Also: Mozobil, Plerixafor | Drug | Arm 1 - Donor |
| Leukopheresis | Procedure or surgery | Arm 1 - Donor |
| Stem cell transplant | Procedure or surgery | Arm 2 - Recipient |
Primary outcome
Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant
Time frame: Completion of enrollment of all donors (17 months)
13 secondary outcomes
Number of Donors Who Experience Grade 3-4 Infusional Toxicity
Time frame: Up to Day 2
Number of Recipients Who Have Neutrophil Engraftment
Time frame: Day 21
Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)
Time frame: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Half Life
Time frame: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)
Time frame: Day 1 and Day 2
Rate of Acute GVHD (Grade II-IV) in Recipients
Time frame: Day 0-Day 100 (acute)
Rate of Acute GVHD (Grade III-IV) in Recipients
Time frame: Day 0-Day 100 (acute)
Time to Neutrophil Engraftment for Recipients
Time frame: Up through Day 100
Time to Platelet Engraftment for Recipients
Time frame: Up to Day 100
Transplant Related Mortality Rate for Recipients
Time frame: Day 100
Grade 3-4 Toxicity for Recipients
Time frame: 1 year
Rate of Chronic GVHD in Recipients
Time frame: Day 101-1 year
Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure
Time frame: Up to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12531874Levesque JP, Hendy J, Takamatsu Y, Simmons PJ, Bendall LJ. Disruption of the CXCR4/CXCL12 chemotactic interaction during hematopoietic stem cell mobilization induced by GCSF or cyclophosphamide. J Clin Invest. 2003 Jan;111(2):187-96. doi: 10.1172/JCI15994.
- Background: PubMed 9933168Peled A, Petit I, Kollet O, Magid M, Ponomaryov T, Byk T, Nagler A, Ben-Hur H, Many A, Shultz L, Lider O, Alon R, Zipori D, Lapidot T. Dependence of human stem cell engraftment and repopulation of NOD/SCID mice on CXCR4. Science. 1999 Feb 5;283(5403):845-8. doi: 10.1126/science.283.5403.845.
- BackgroundBroxmeyer HE, Hangoc G, Cooper S, Bridger G. Interference of the SDF-1/CXCR4 axis in mice with AMD3100 induces rapid high level mobilization of hematopoietic progenitor cells, and AMD3100 acts synergistically with G-CSF and MIP-1 alpha to mobilize progenitors. Blood. 2001;96:3371a
- BackgroundBroxmeyer HE, Hangoc G, Cooper S, Li X, Bridger G, Clapp DW. AMD3100, an antagonist of CXCR4 and mobilizer of myeloid progenitor cells, is a potent mobilizer of competitive repopulating long term marrow self renewing stem cells in mice. Blood. 2002;98:2397a
- Background: PubMed 12855591Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15;102(8):2728-30. doi: 10.1182/blood-2003-02-0663. Epub 2003 Jul 10.
- BackgroundDevine S, Adkins D, Khoury H, Vij R, Goodnough LT, Graubert T, Tomasson M, Blum W, DiPersio J, Brown R. Mobilization of donors with GM-CSF plus G-CSF or GM-CSF alone results in significantly different graft composition compared to G-CSF alone. Blood. 2002;100:825a
- Background: PubMed 18426988Devine SM, Vij R, Rettig M, Todt L, McGlauchlen K, Fisher N, Devine H, Link DC, Calandra G, Bridger G, Westervelt P, Dipersio JF. Rapid mobilization of functional donor hematopoietic cells without G-CSF using AMD3100, an antagonist of the CXCR4/SDF-1 interaction. Blood. 2008 Aug 15;112(4):990-8. doi: 10.1182/blood-2007-12-130179. Epub 2008 Apr 21.
- Background: PubMed 15837815Broxmeyer HE, Orschell CM, Clapp DW, Hangoc G, Cooper S, Plett PA, Liles WC, Li X, Graham-Evans B, Campbell TB, Calandra G, Bridger G, Dale DC, Srour EF. Rapid mobilization of murine and human hematopoietic stem and progenitor cells with AMD3100, a CXCR4 antagonist. J Exp Med. 2005 Apr 18;201(8):1307-18. doi: 10.1084/jem.20041385.
- Background: PubMed 17382247Hess DA, Bonde J, Craft TP, Wirthlin L, Hohm S, Lahey R, Todt LM, Dipersio JF, Devine SM, Nolta JA. Human progenitor cells rapidly mobilized by AMD3100 repopulate NOD/SCID mice with increased frequency in comparison to cells from the same donor mobilized by granulocyte colony stimulating factor. Biol Blood Marrow Transplant. 2007 Apr;13(4):398-411. doi: 10.1016/j.bbmt.2006.12.445.
- Derived from this study: PubMed 28292947Schroeder MA, Rettig MP, Lopez S, Christ S, Fiala M, Eades W, Mir FA, Shao J, McFarland K, Trinkaus K, Shannon W, Deych E, Yu J, Vij R, Stockerl-Goldstein K, Cashen AF, Uy GL, Abboud CN, Westervelt P, DiPersio JF. Mobilization of allogeneic peripheral blood stem cell donors with intravenous plerixafor mobilizes a unique graft. Blood. 2017 May 11;129(19):2680-2692. doi: 10.1182/blood-2016-09-739722. Epub 2017 Mar 14.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
John DiPersio, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMD3100, Leukopheresis and Stem cell transplant in people with Hematologic Neoplasms, run by Washington University School of Medicine 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 42 inclusion and 1 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 17 May 2017. 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 phase mean?
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 24 Aug 2016). 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 Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant (time frame: Completion of enrollment of all donors (17 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00914849, which also lists 10 linked publications.
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 17 May 2017.