NCT00241358 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2017-06-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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)

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)

→

outcome · POSTED

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

→

outcome · POSTED

Quality of Life During Stem Cell Mobilization (Recipients Only)

→

outcome · POSTED

Proportion of Donors Who Experience Infusional Toxicity (Donor Only)

→

outcome · POSTED

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

→

outcome · POSTED

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

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: 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
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
* 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.
intervention Names
Drug: AMD3100
label
Subcutaneous (SC) Treatment Plan - Donor
type
ACTIVE_COMPARATOR
description
* 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.
intervention Names
Drug: AMD3100
label
Intravenous (IV) Treatment Plan - Donor
type
EXPERIMENTAL
description
* 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
intervention Names
Procedure: Stem Cell Transplant
label
Recipients
type
OTHER

interventions

arm Group Labels
Intravenous (IV) Treatment Plan - Donor
Subcutaneous (SC) Treatment Plan - Donor
name
AMD3100
other Names
Plerixafor
type
DRUG
arm Group Labels
Recipients
name
Stem Cell Transplant
type
PROCEDURE

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 92
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
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
description
-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria
measure
Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)
time Frame
By Day 100 after transplant
description
-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir
measure
Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
time Frame
Day +21

secondary Outcomes

description
-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
measure
Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)
time Frame
Between Day +100 and +365 post-transplant
description
-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
measure
Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
time Frame
100 days after transplant
measure
Quality of Life During Stem Cell Mobilization (Recipients Only)
time Frame
48-72 hours after last dose of AMD3100
description
-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
measure
Proportion of Donors Who Experience Infusional Toxicity (Donor Only)
time Frame
Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)
description
-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
measure
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax
time Frame
0 to 24 hours after dose of IV AMD3100
description
-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
measure
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity
time Frame
0 to 24 hours after dose of IV AMD3100

Full study description

brief 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.
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.

Source references

references

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.
pmid
18426988
type
BACKGROUND
citation
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.
pmid
15020611
type
BACKGROUND
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. doi: 10.1182/blood-2005-02-0468. Epub 2005 May 12.
pmid
15890685
type
BACKGROUND
citation
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.
pmid
28292947
type
DERIVED