Feasibility and Efficiency Study of Leukemic Cell Mobilization With Plerixafor Injection

NCT01141543 | Completed DMC

• 1 other identifier: 09-0756-C
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted as a single center Phase I/II study to evaluate the safety of administering Plerixafor administered as part of a myeloablative preparative regimen (Institutional Protocol:Fludarabine 50mg/m2/da x 4 days, Busulfan 3.2mg/kg/day x 4 days, TBI 400cGy in divided fractions) for stem cell transplant recipients with AML and to determine whether or not residual leukemic stem cells can be mobilized. Three patients will be enrolled into each of 4 sequential cohorts. Patients in the first cohort will receive 1 dose of Plerixafor (240mcg/kg sc) prior to administration of the first dose of Fludarabine and Busulfan. If tolerated it is planned to escalate the number of Plerixafor doses in the subsequent cohorts to 2. 3. and 4 to be administered before the respective 2nd, 3rd, and 4th dose of chemotherapy.

Conditions

Acute Myeloid Leukemia

Keywords

Plerixafor injection

Outcome Measures

Primary Outcomes (1)

• Adverse events as a measure of safety and tolerability using Plerixafor in conjunction with a myeloablative preparative regimen for a patients with AML undergoing an allogenic stem cell transplantation.

  As primary endpoint the study is to establish whether or not the administration of Plerixafor during administration of a myeloablative preparative regimen for recipients of allografts can be tolerated.we will complete full protocol with a follow up period of 30 days for first patient than futher patients will be enrolled.Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be evaluated in the study.

  one year

Secondary Outcomes (6)

• Quantification of leukemic progenitor cells after administration of Plerixafor as a myeloablative preparative regimen for a patient with AML undergoing a stem cell transplantation.

  one year

• Quantification of leukemic progenitor cells after administration of Plerixafor as a myeloablative preparative regimen for a patient with AML undergoing a stem cell transplantation.

  One Year

• Quantification of leukemic progenitor cells after administration of Plerixafor as a myeloablative preparative regimen for a patient with AML undergoing a stem cell transplantation.

  one year

• Quantification of leukemic progenitor cells after administration of Plerixafor as a myeloablative preparative regimen for a patient with AML undergoing a stem cell transplantation.

  one year

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be evaluated in the study.

  one year

Study Arms (4)

cohort 1

Patients in Cohort 1 will be followed with daily Flowcytometric studies to quantify CXCR4 positive cells.The samples will be obtained before the following doses of FLUDARABINE and BUSULFAN. Eighteen hrs (range 18 -20 hrs) after start of the last dose of FUDARABINE andBUSULFAN and before the first dose of TBI a PB sample as well as bone marrow aspirate and biopsy will be obtained to repeat the studies as conducted prior to the first dose of PLERIXAFOR

Drug: Plerixafor (mozobil)

Cohort 2

Patients in Cohort 2 will receive the second dose of PLERIXAFOR 24 hrs after the first dose. A PB sample for a CBS and Flowcytometry will be drawn prior to the dose. Nine hrs later a further study sample for Flowcytometry will be obtained prior to administration of the second dose of FLUARABINE and BUSULFAN. Flowcytometric studies will be repeated on day 3 and 4. Eighteen hrs (range 18 - 20 hrs) after start of the last dose of FLUDARABINE and BUSULFAN and before the first dose of TBI a PB sample as well as bone marrow aspirate and biopsy will be obtained to repeat the studies as conducted prior to the first dose of PLERIXAFOR.

Drug: Plerixafor (mozobil)

cohort 3

Cohort 3: Administration of PLERIXAFOR (240mcg/kg sc) before the first, second, and third dose of FLUARABINE and BUSULFAN

Drug: Plerixafor (mozobil)

Cohort 4

Administration of PLERIXAFOR (240mcg/kg sc) before all four doses of FLUDARABINE and BUSULFAN

Drug: Plerixafor (mozobil)

Interventions

Plerixafor (mozobil) DRUG

Cohort 1: Administration of PLERIXAFOR (240mcg/kg sc) before the first dose of FLUDARABINE and BUSULFAN Cohort 2: Administration of PLERIXAFOR (240mcg/kg sc) before the first and second dose of FLUDARABINE and BUSULFAN. Cohort 3: Administration of PLERIXAFOR (240mcg/kg sc) before the first, second, and third dose of FLUARABINE and BUSULFAN Cohort 4: Administration of PLERIXAFOR (240mcg/kg sc) before all four doses of FLUDARABINE and BUSULFAN

Also known as: Mozobil

Cohort 2; Cohort 4; cohort 1; cohort 3

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will be performed on patients undergoing myeloablative allogeneic stem cell transplants (PBSC or BM) from related or unrelated donors for the treatment of patients with AML in remission.

You may qualify if:

• Patients with AML in remission.
• Availability of a suitably matched related or unrelated donor
• Age 18-60 years
• Eligibility for a myeloablative transplant using the Institutional protocols R-FBT(400)-CSMF as preparative regimen for related donors and U-FBT(400)-CP(30)CS for unrelated donors.
• Eligible subjects who are illiterate will be offered participation in the study

You may not qualify if:

• Patients aged 61years or older
• Patients not eligible for the preparative regimens R-FBT(400)-CSMF or U-FBT(400)-CP(30)CS
• Pregnant or lactating females
• Creatinine of .\>2x normal
• Bilirubin, AST, ALT \> 2x normal
• MUGA of \<50%

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Michelis FV, Hedley DW, Malhotra S, Chow S, Loach D, Gupta V, Kim DD, Kuruvilla J, Lipton JH, Viswabandya A, Messner HA. Mobilization of Leukemic Cells Using Plerixafor as Part of a Myeloablative Preparative Regimen for Patients with Acute Myelogenous Leukemia Undergoing Allografting: Assessment of Safety and Tolerability. Biol Blood Marrow Transplant. 2019 Jun;25(6):1158-1163. doi: 10.1016/j.bbmt.2019.01.014. Epub 2019 Jan 14.

  PMID: 30654137 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

plerixafor

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hans Messner, Ph.D

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

CA (1)