Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00733824
First received: August 11, 2008
Last updated: February 8, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma.
We hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin Hodgkin Disease |
Drug: AMD3100 Drug: G-CSF Procedure: Apheresis |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- To determine the maximum tolerated dose of IV AMD3100 + G-CSF in mobilization of peripheral blood stem cell in patients with lymphoma [ Time Frame: 7 days from first dose of IV AMD3100 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the kinetics of stem cell mobilization using IV AMD3100 in this patient population [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine whether the pharmacodynamic response to a dose of SC AMD3100, as measured by circulating CD34+ cell count, correlates with stem cell mobilization with G-CSF and with G-CSF + IV AMD3100. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine the toxicity and efficacy of the combination IV AMD3100 and G-CSF to mobilize ≥ 2 x 106 CD34+ cells/kg from patients with lymphoma (Hodgkin and non-Hodgkin) who are undergoing autologous stem cell transplantation [ Time Frame: Toxicity=30 days post transplant, Efficacy = 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
240 µg/kg SC AMD3100 Day -5, 10 µg/kg SC G-CSF Day -4 thru Day -1, 160 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1, Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Drug: AMD3100
Other Name: Plerixafor
Drug: G-CSF
G-CSF 10 µg/kg SQ qd from day -4 and continuing daily until apheresis is complete
Other Names:
Procedure: Apheresis
Apheresis will be performed 4 hours after the administration of AMD3100 on day 0. The procedure will be repeated for up to 3 additional consecutive days of apheresis in order to collect an adequate number of cells for transplantation.
Other Name: Leukopheresis
|
|
Experimental: Cohort 2
240 µg/kg SC AMD3100 Day -5, 10 µg/kg SC G-CSF Day -4 thru Day -1, 240 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1, Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Drug: AMD3100
Other Name: Plerixafor
Drug: G-CSF
G-CSF 10 µg/kg SQ qd from day -4 and continuing daily until apheresis is complete
Other Names:
Procedure: Apheresis
Apheresis will be performed 4 hours after the administration of AMD3100 on day 0. The procedure will be repeated for up to 3 additional consecutive days of apheresis in order to collect an adequate number of cells for transplantation.
Other Name: Leukopheresis
|
|
Experimental: Cohort 3
240 µg/kg SC AMD3100 Day -5, 10 µg/kg SC G-CSF Day -4 thru Day -1, 320 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1, Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Drug: AMD3100
Other Name: Plerixafor
Drug: G-CSF
G-CSF 10 µg/kg SQ qd from day -4 and continuing daily until apheresis is complete
Other Names:
Procedure: Apheresis
Apheresis will be performed 4 hours after the administration of AMD3100 on day 0. The procedure will be repeated for up to 3 additional consecutive days of apheresis in order to collect an adequate number of cells for transplantation.
Other Name: Leukopheresis
|
|
Experimental: Cohort 4
240 µg/kg SC AMD3100 Day -5, 10 µg/kg SC G-CSF Day -4 thru Day -1, 400 µg/kg IV AMD3100 and 10 µg/kg SC G-CSF Day 1, Pheresis (this will be repeated on Day 2 through Day 4 until target of ≥5X106 CD34+ cell/kg is reached)
|
Drug: AMD3100
Other Name: Plerixafor
Drug: G-CSF
G-CSF 10 µg/kg SQ qd from day -4 and continuing daily until apheresis is complete
Other Names:
Procedure: Apheresis
Apheresis will be performed 4 hours after the administration of AMD3100 on day 0. The procedure will be repeated for up to 3 additional consecutive days of apheresis in order to collect an adequate number of cells for transplantation.
Other Name: Leukopheresis
|
|
Experimental: Phase II
MTD as determined in Phase I
|
Drug: AMD3100
Other Name: Plerixafor
Drug: G-CSF
G-CSF 10 µg/kg SQ qd from day -4 and continuing daily until apheresis is complete
Other Names:
Procedure: Apheresis
Apheresis will be performed 4 hours after the administration of AMD3100 on day 0. The procedure will be repeated for up to 3 additional consecutive days of apheresis in order to collect an adequate number of cells for transplantation.
Other Name: Leukopheresis
|
Detailed Description:
Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse after a chemotherapy-induced complete remission. For these patients, as for other patients undergoing autologous transplantation, the number of CD34+ cells collected is a reliable predictor of neutrophil and platelet (PLT) engraftment after transplantation.
AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis, which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34+ cell count, so that the drug can be administered the same day as apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the number of CD34+ cells collected via apheresis.
This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 to 75 years
- Diagnosis of HL or NHL eligible for autologous transplantation
- 30 days since last cycle of chemotherapy
- ECOG performance status of 0 or 1
- The patient has recovered from all acute toxic effects of prior chemotherapy
- WBC >3.0 X 109/l
- Absolute PMN count >1.5 X 109/l
- PLT count >100 X 109/l
- Serum creatinine ≤ 2.2 mg/dl
- AST (SGOT), ALT (SGPT) and total bilirubin < 2X upper limit of normal (ULN)
- Left ventricle ejection fraction > 45% (by ECHO or MUGA scan)
- FEV1 > 60% of predicted or DLCO > 45% of predicted
- Negative for HIV on standard transplant workup
- Signed informed consent
Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
- Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
- Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
Exclusion Criteria:
- 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
- Acute infection
- Fever (temp >38C/100.4F) on the day of start of treatment
- 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 150% of their ideal body weight
- History of ventricular arrhythmias
- 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 phase
- Patients who have deterioration of their clinical status or laboratory parameters between the time of enrollment and transplantation such that they no longer meet entry criteria may be removed from study at the discretion of the treating physician, principal investigator, or sponsor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733824
Locations
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Amanda F. Cashen, M.D. | Washington Univerisity |
More Information
Additional Information:
Publications:
DiPersio JF, Micallef I, Stiff PJ, et al. A Phase III, Multicenter, Randomized, Double-Blind, Placebo Controlled, Comparative Trial of AMD3100 (Plerixafor)+G-CSF vs. Placebo+G-CSF in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Hematopoietic Stem Cell (aHSC) Transplantation. ASH Annual Meeting Abstracts. November 16, 2007 2007;110(11):601-.
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00733824 History of Changes |
| Other Study ID Numbers: | 08-0897 / 201105349 |
| Study First Received: | August 11, 2008 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Washington University School of Medicine:
|
Plerixafor Lymphoma Hematopoietic Stem Cell Mobilization Transplantation, Autologous Receptors, CXCR4 |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases JM 3100 Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013