AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

NCT00396201 | Completed Phase 2 Results

• 1 other identifier: AMD3100-2106
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

Conditions

Hodgkin's Disease

Keywords

Hodgkin's Disease; Stem cell mobilization; apheresis

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF

  The proportion of total participants who mobilized ≥5\*10\^6 CD34+ cells/kg based on data from local laboratories.

  Day 5 up to Day 9

Secondary Outcomes (13)

• Overall Participant Counts of Adverse Events During the Treatment Period

  Day 0 - approximately day 38

• Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF

  Day 5 up to day 9

• Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL

  Days 4-5 (first dose of plerixafor to apheresis)

• Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg

  Day 5 up to day 9

• Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment

  Up to Month 13 (up to 12 months post transplant)

Study Arms (1)

Participants with Hodgkin's Disease (HD)

EXPERIMENTAL

Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation.

Drug: G-CSF Plus Plerixafor

Interventions

G-CSF Plus Plerixafor DRUG

Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

Also known as: Mozobil, AMD3100

Participants with Hodgkin's Disease (HD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HD eligible for autologous transplantation
• No more than 3 prior regimens of chemotherapy (Rituximab is not considered chemotherapy for the purpose of this study.)
• weeks since last cycle of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• The patient has recovered from all acute toxic effects of prior chemotherapy
• White blood cell count (WBC) \>3.0\*10\^9/L
• Absolute polymorphonuclear cells (PMN) count \>1.5\*10\^9/L
• Platelet (PLT) count \>100\*10\^9/L
• Serum creatinine ≤2.2 mg/DL
• Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin \<2 x upper limit of normal (ULN)
• Left ventricle ejection fraction \>45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
• Forced expiratory volume of the lung in the first second (FEV1) \>60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) \>45% of predicted
• Negative for human immunodeficiency virus (HIV)

You may not qualify if:

• A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
• Patients who have failed previous collections
• A residual acute medical condition resulting from prior chemotherapy
• Hodgkin's disease involving the central nervous system
• Acute infection
• Fever (temp \>38°C/100.4°F)
• Patients whose actual body weight exceeds 150% of their ideal body weight
• History of ventricular arrhythmias
• History of paresthesias
• Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

Washington University School of Medicine,Division of Bone Marrow Transplantation & Leukemia

St Louis, Missouri, 63110-1093, United States

Location

Related Publications (1)

• Cashen A, Lopez S, Gao F, Calandra G, MacFarland R, Badel K, DiPersio J. A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma. Biol Blood Marrow Transplant. 2008 Nov;14(11):1253-61. doi: 10.1016/j.bbmt.2008.08.011.

  PMID: 18940680 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Granulocyte Colony-Stimulating Factor; plerixafor

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Genzyme Medical Information
• Organization: Genzyme Corporation

800-745-4447

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: November 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: January 1, 2008
• Last Updated: March 13, 2014
• Results First Posted: October 6, 2010

Record last verified: 2014-02

Locations

US (1)