Phase 2
Completed N=25
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
Lymphoma, Non-Hodgkin · Hodgkin Disease
Source: ClinicalTrials.gov NCT00733824 ↗
Enrolled (actual)
25
Serious AEs
4.9%
Results posted
Oct 2016
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only) — 400 micrograms/kilograms
Summary
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.
The investigators 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only) |
400 | — |
| PRIMARY Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study |
0; 0; 0; 0 | — |
| SECONDARY Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration |
2.1 | — |
| SECONDARY Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype |
49.0 | — |
| SECONDARY Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event |
3; 2; 4; 4; 20; 4 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00733824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.