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A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell Collection/Attempts


Phase 2
18 Years
78 Years
Not Enrolling
Both
Autologous Stem Cell Transplantation

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Trial Information

A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell Collection/Attempts


This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have
enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who
would benefit from an autologous stem cell transplant, who have failed previous collections
or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor
(G-CSF) alone, chemotherapy and G-CSF, or any other conventional therapy including
cytokines, chemotherapy and cytokines and bone marrow harvests, and who meet the
inclusion/exclusion criteria are eligible to receive plerixafor as outlined in this
protocol. The only change to standard of care of a mobilization regimen that includes G-CSF
is the addition of a dose of plerixafor on the evening prior to each day of apheresis.

Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, plerixafor
(240 µg/kg) will be administered in the evening prior to the first apheresis and each
subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour
interval between dosing and the initiation of apheresis. Patients will continue to receive
G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7
aphereses or until ≥2*10^6 CD34+ cells/kg are collected, whichever occurs first. In
addition, the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of
plerixafor will be examined.

After the last apheresis has been completed, or after the patient has collected ≥2*10^6
CD34+ cells/kg, he/she will be treated with high-dose chemotherapy in preparation for
transplantation. Patients will be transplanted with cells obtained from the G-CSF with
plerixafor mobilization regimen. In the event that the minimum number of ≥2*10^6 cells for
transplantation are not obtained from the first mobilization with plerixafor, cells may be
retained and pooled for transplantation with those from a second mobilization with
plerixafor (or from prior mobilization with other agents), at the investigator's discretion.
If a second mobilization with plerixafor is attempted, a minimum rest interval of one week
should be allowed between the last apheresis of the first regimen and the first dose of
G-CSF of the second. The number of CD34+ cells mobilized in the peripheral blood (PB),
collected in the apheresis product, and the number of apheresis sessions performed will be
measured. Success of the transplantation will be evaluated by the time to engraftment of
polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be assessed for
durability of their transplant for 12 months after transplantation.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.


Inclusion Criteria:



- Eligible to undergo autologous transplantation

- Has failed previous collections or collection attempts with a mobilization regimen of
granulocyte colony-stimulating factor (G-CSF), chemotherapy and G-CSF or any other
conventional therapy including cytokines, chemotherapy and cytokines or bone marrow
harvest.

- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1

- ≥3 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade™
are not considered prior chemotherapy for the purpose of this study) NOTE: Although
thalidomide, dexamethasone, and Velcade™ are not considered prior chemotherapy for
the purpose of this study, none are to be administered within 7 days prior to the
first dose of G-CSF (see Exclusion Criteria).

- The patient has recovered from all acute toxic effects of prior chemotherapy

- White blood cell count (WBC) >2.5*10^9/L

- Absolute neutrophil count >1.5*10^9/L

- Platelet count >85*10^9/L

- Serum creatinine ≤1.5 mg/dl

- Creatinine clearance >60 ml/min

- Aspartate aminotransferase (AST), alanine transaminase (ALT) and total bilirubin <2x
upper limit of normal (ULN)

- Left ventricle ejection fraction >45% (by normal echocardiogram (ECHO) or multiple
gated acquisition (MUGA) scan)

- Forced expiratory volume in one minute (FEV1) >60% of predicted or diffusion lung
capacity for carbon monoxide (DLCO) ≥45% of predicted

- No active infection of hepatitis B or C

- Negative for HIV

- Signed informed consent

- Women of child-bearing potential agree to use an approved form of contraception

Exclusion Criteria:

- Once 70 patients have enrolled, patients with diagnoses other than lymphoma are not
eligible (eg, acute myeloid leukemia, chronic lymphocytic leukemia, or multiple
myeloma).

- A co-morbid condition which, in the view of the investigators, renders the patient at
high risk from treatment complications

- A residual acute medical condition resulting from prior chemotherapy

- Received Neupogen™, thalidomide, dexamethasone, and/or Velcade™ within 7 days prior
to the first dose of G-CSF

- Brain metastases or carcinomatous meningitis

- Acute infection

- Fever (temperature >38°C/100.4°F)

- Hypercalcaemia (>1 mg/dL above the ULN)

- Positive pregnancy test in female patients

- Lactating females

- Patients of child-bearing potential unwilling to implement adequate birth control

- Patients whose actual body weight exceeds 175% of their ideal body weight

- Patients who previously received experimental therapy within 4 weeks of enrolling in
this protocol or who are currently enrolled in another experimental protocol during
the Mobilization phase

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period

Outcome Description:

Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').

Outcome Time Frame:

Day 1 to approximately day 38

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD31002112

NCT ID:

NCT00396331

Start Date:

October 2005

Completion Date:

December 2009

Related Keywords:

  • Autologous Stem Cell Transplantation
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
  • autologous transplantation
  • AMD3100
  • stem cell mobilization
  • plerixafor

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Kansas City Cancer CentersKansas City, Missouri  64111
City of Hope National Medical Center`Duarte, California  91010
Blood & Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342
University of Mississippi Medical Center, Div of HematologyJackson, Mississippi  39216
Virginia Commonwealth University - Massey Cancer CenterRichmond, Virginia  23298-0037
University of Wisconsin, Blood and Bone Marrow TransplantMadison, Wisconsin  53792-5156