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A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant

Phase 2
18 Years
70 Years
Not Enrolling
Non-Hodgkin Lymphoma, Hodgkin Disease

Thank you

Trial Information

A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant

This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of
plerixafor when used in combination with rituximab (Rituxan®) and granulocyte
colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease
(HD) or non-Hodgkin lymphoma (NHL).

Participants will be assigned to one of 2 arms based on the immunophenotype of their

(A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.

(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and
plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv)
infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of

Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening)
for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240
µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10
to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice
daily and to receive the evening dose of plerixafor followed by apheresis the next morning
for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.

Participants with an adequate number of autologous peripheral blood stem cells (PBSCs)
collected by apheresis will be admitted to the study center for the administration of
high-dose chemotherapy and autologous transplantation. After transplantation, the times to
PMN, PLT, and lymphocyte engraftment will be measured. Participants will remain
hospitalized until they achieve an absolute granulocyte count of >500/µl in the peripheral
blood. Graft durability will be assessed at 100 days, and 6 and 12 months

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

Inclusion Criteria (abbreviated list):

- Histological diagnosis of diffuse large cell lymphoma, B-cell, T-cell or anaplastic
histologies; peripheral T-cell lymphoma; small non-cleaved Burkitt-like lymphoma; or
Hodgkin disease. NOTE: Participants diagnosed at a facility outside of Emory
University will have their diagnosis confirmed by Emory University pathologists prior
to being enrolled in this study.

- Eligible for autologous transplantation.

- History of relapse of lymphoma following initial treatment with an
anthracycline-containing regimen or disease that is refractory or progresses during
initial therapy with an anthracycline-containing regimen.

- Immunophenotyping of the lymphoma at the time of diagnosis or relapse using flow
cytometry or immunohistochemistry.

- Presence of clinically- and/or radiologically-documented, measurable, and/or
evaluable disease at the time of relapse.

- Received 2 cycles of salvage chemotherapy.

- Complete response (i.e., normal physical examination, lymph nodes, lymph node masses,
and bone marrow) or a partial response (i.e., decrease of ≧50% in the size of lymph
nodes or lymph node masses or decrease in size of liver/spleen on physical exam) to
at least one cycle of a salvage chemotherapy regimen.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

- Absolute granulocytes count ≧1.0*10^9/l.

- Platelet count ≧75*10^9/l.

- Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≦2.5 times the upper
limit of normal (ULN) or ≦5 times the ULN if liver involvement with lymphoma.

- Life expectancy of at least 3 months.

- >4 weeks since last cycle of chemotherapy.

- Patient has recovered from all acute toxic effects of prior chemotherapy.

- Signed informed consent.

Exclusion Criteria (abbreviated list):

- A second active malignancy (other than basal cell carcinoma of the skin).

- Uncontrolled central nervous system involvement by lymphoma.

- Positive/history of retroviral infection (HIV, HTLV-1).

- Active infection requiring antibiotics during planned lymphoma-related therapy.

- Previous treatment with high-dose chemotherapy or cytokine mobilization and
hematopoietic progenitor cell transplantation.

- Continued evidence by morphology and flow cytometry of bone marrow involvement after
at least one cycle of salvage chemotherapy.

- ≥3 cycles of salvage chemotherapy following documentation of lymphoma relapse or
disease progression.

- (In patients with CD20(+) lymphoma) History of severe hypersensitivity reactions to

- Positive pregnancy test in female patients.

- Lactating female patients.

- Previously received experimental therapy within 4 weeks of enrolling in this protocol
or currently enrolled in another experimental protocol during G-CSF Mobilization

- Creatinine >1.5 times the ULN.

- Bilirubin >1.5 times the ULN.

- Ejection fraction <45%.

- Diffusion capacity of the lung for carbon monoxide (DLCO) <50%.

- Patients of childbearing potential unwilling to implement adequate birth control.

- A co-morbid condition that renders the patient at high risk from treatment

- Residual acute medical condition resulting from prior chemotherapy.

- Documented history of ventricular arrhythmias during the last 3 years.

- Fever (temperature >38 °C/100.4 °F).

- Actual body weight exceeds 175% of ideal body weight.

- Participants who have deterioration of their clinical status or laboratory parameters
between the time of enrolment and transplant (such that they no longer meet entry
criteria) may be removed from study at the discretion of the treating physician,
principal investigator, or sponsor.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Summary of Adverse Events (AEs)

Outcome Description:

Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) 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 seriousness and relatedness to study treatment.

Outcome Time Frame:

Day 1 and up to Day 59 (maximum time before start of chemotherapy)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

June 2009

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • AMD3100
  • stem cell mobilization
  • autologous transplant
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Winship Cancer Institute Atlanta, Georgia  30322