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Leukemia, Myeloid, AcutePhase 1/2NCT00241358

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies

A Phase 1/2 study testing AMD3100 and Stem Cell Transplant in people with Leukemia, Myeloid, Acute and Leukemia, Myelogenous, Chronic, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
AMD3100 and Stem Cell Transplant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteUnited States
Study dates
May 2004to Feb 2010
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

  • Donor criteria:
  • Donor is 18 to 70 years of age inclusive
  • If female and of child-bearing age, must be:
  • non-pregnant,
  • not breast feeding and
  • using adequate contraception
Show all 51Show fewer
  • Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell 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.
  • 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.
  • No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication
  • Must be HIV-1 \& 2 antibody, HIV-1 antigen, and HTLV-I \& II antibody sero-negative, by FDA licensed test.
  • Must have an ECOG performance status of 0 or 1
  • Must demonstrate ability to be compliant with study regimen.
  • Must not have an active infection at the time of study entry
  • Not have active alcohol or substance abuse within 6 months of study entry
  • Not currently enrolled in another investigational agent study
  • Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation
  • Recipient criteria:
  • 18 to 65 years of age inclusive
  • Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant
  • Provide signed informed consent
  • If female and of child-bearing age, must be:
  • non-pregnant,
  • not breast feeding, and
  • using adequate contraception
  • Patient must have one of the following diagnoses:
  • AML in 1st or subsequent remission or in relapse
  • ALL in 1st or subsequent remission or in relapse
  • MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System
  • CML in accelerated or second chronic phase
  • NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse
  • CLL Rai Stage 2-4, failing at least 2 prior regimens
  • 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 forced expiratory volume at 1 second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide (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 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 the time of transplantation
  • Patient must be HIV-1 \& 2 antibody, HIV-1 antigen, and HTLV-I \& II antibody sero-negative, by FDA licensed test
  • ECOG performance status of 0 or 1
  • Must demonstrate ability to be compliant with medical regimen
  • Not have active alcohol or substance abuse within 6 months of study entry
  • Not be concurrently enrolled on another study involving an investigational agent
  • Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Read the detailed description

This study will determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Being tested
AMD3100, Stem Cell Transplant
Keywords
Plerixafor, Stem cell transplantation, Stem cells, Mobilization
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Myelodysplastic Syndromes, Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMD3100Drug

    Also called Plerixafor

  • Stem Cell TransplantProcedure or surgery

Study groups in NCT00241358
Study groupRoleWhat they receive
Subcutaneous (SC) Treatment Plan - DonorActive comparator* Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
Receives: Drug: AMD3100
Intravenous (IV) Treatment Plan - DonorExperimental* Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
Receives: Drug: AMD3100
RecipientsOther* Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis *Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
Receives: Procedure: Stem Cell Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)

    -Defined as the proportion of donors collecting >2.0x106 CD34+ cells/kg [recipient weight]

    Measured: Day 1-3

  2. Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)

    -Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria

    Measured: By Day 100 after transplant

  3. Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)

    -Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir

    Measured: Day +21

Secondary outcomes (6)

  1. Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)

    -Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria

    Measured: Between Day +100 and +365 post-transplant

  2. Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)

    -Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause

    Measured: 100 days after transplant

  3. Quality of Life During Stem Cell Mobilization (Recipients Only)

    Measured: 48-72 hours after last dose of AMD3100

  4. Proportion of Donors Who Experience Infusional Toxicity (Donor Only)

    -Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion

    Measured: Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)

  5. To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax

    -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion

    Measured: 0 to 24 hours after dose of IV AMD3100

  6. To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity

    -Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion

    Measured: 0 to 24 hours after dose of IV AMD3100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionDec 2009
  4. Study completionFeb 2010

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00241358
Sponsor's protocol ID
03-0349
Status last verified
Jun 2017
First submitted
17 Oct 2005
Last updated
6 Jun 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 18426988

  • Devine SM, Flomenberg N, Vesole DH, Liesveld J, Weisdorf D, Badel K, Calandra G, DiPersio JF. Rapid mobilization of CD34+ cells following administration of the CXCR4 antagonist AMD3100 to patients with multiple myeloma and non-Hodgkin's lymphoma. J Clin Oncol. 2004 Mar 15;22(6):1095-102. doi: 10.1200/JCO.2004.07.131.

    PubMed 15020611

  • Flomenberg N, Devine SM, Dipersio JF, Liesveld JL, McCarty JM, Rowley SD, Vesole DH, Badel K, Calandra G. The use of AMD3100 plus G-CSF for autologous hematopoietic progenitor cell mobilization is superior to G-CSF alone. Blood. 2005 Sep 1;106(5):1867-74. doi: 10.1182/blood-2005-02-0468. Epub 2005 May 12.

    PubMed 15890685

  • Schroeder 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMD3100 and Stem Cell Transplant in people with Leukemia, Myeloid, Acute and Leukemia, Myelogenous, Chronic, 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 51 inclusion and 0 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 6 Jun 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 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 6 Jun 2017). 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?

Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only) (time frame: Day 1-3). The study lists 3 primary outcomes in all. 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 NCT00241358, which also lists 4 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 6 Jun 2017.

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