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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00241358
Other study ID # 03-0349
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 17, 2005
Last updated June 5, 2017
Start date May 2004
Est. completion date February 2010

Study information

Verified date June 2017
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date February 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AMD3100

Procedure:
Stem Cell Transplant


Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2005 May 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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] Day 1-3
Primary 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 By Day 100 after transplant
Primary Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only) -Defined as neutrophil count = 500/ul following conditioning regimen induced nadir Day +21
Secondary Proportion of Recipients Who Experience Chronic GVHD (Recipient Only) -Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria Between Day +100 and +365 post-transplant
Secondary 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 100 days after transplant
Secondary Quality of Life During Stem Cell Mobilization (Recipients Only) 48-72 hours after last dose of AMD3100
Secondary 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 Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)
Secondary 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 0 to 24 hours after dose of IV AMD3100
Secondary 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 0 to 24 hours after dose of IV AMD3100
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