EUCTR2006-004247-29-DE进行中（未招募）不适用
A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients with Non-Hodgkin’s Lymphoma (NHL), Hodgkin’s Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 18 to 78 years.
- •2. Eligible to undergo autologous transplantation.
- •3. Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias, including chronic lymphocytic leukemia (CLL), are excluded].
- •4. In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8X10E6 cells/kg in at least 2 apheresis sessions or 2X10E6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF.
- •NOTE: The complete history of the failed collection and/or collection attempts, including the mobilization regimen, apheresis yield(s), and/or peripheral blood (PB) CD34+ cell count(s) will be documented and submitted to Genzyme prior to enrollment and randomization.
- •5. A minimum of a 7-day interval between last collection attempt and randomization.
- •6. Performance status, Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (see Appendix E).
- •7. Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant.
- •8. =/> 21 days between the last cycle of chemotherapy (e.g. cyclophosphamide) and randomization (thalidomide, dexamethasone, and other corticosteroids, Rituxan and Velcade are not considered prior chemotherapy for the purpose of this study).
- •9. The patient has recovered from all acute toxic effects of prior chemotherapy.
- •10. WBC > 2.5X10E9/l.
- •11. Absolute neutrophil count >1.5X10E9/l.
- •12. Platelet count > 75X10E9/l.
- •13. Adequate renal function as demonstrated by serum creatinine 60 ml/min.
- •14. Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT) and total bilirubin < 2.5 X upper limit of normal (ULN).
- •15. No active Hepatitis A, B or C infection.
- •16. Signed informed consent.
- •17. All patients must agree to use a highly effective method of contraception (including both female patients of child-bearing potential and male patients with child-bearing potential partners). Effective birth control includes: a) birth control pills, depot progesterone, or an IUD PLUS one barrier method, or b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interaction of AMD3100 with hormonal contraceptives is not known.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications.
- •2. A residual acute medical condition resulting from prior chemotherapy.
- •3. Received thalidomide, dexamethasone or corticosteroids, Rituxan and Velcade within 7 days prior to randomization.
- •4. Brain metastases or carcinomatous meningitis.
- •5. Active acute or chronic infection or anti-infective therapy within 7 days of randomization.
- •6. Fever (temperature > 38°C).
- •7. Hypercalcaemia (> 1 mg/dl above the ULN).
- •8. Known to be HIV-positive.
- •9. Pregnant and nursing females.
- •10. Patient unwilling to implement adequate birth control (including both femalepatients of child-bearing potential and male patients with child-bearing potential partners).
- •11. Patients who previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the Mobilization phase.
- •12. Patients who have failed a previous collection attempt within 7 days or less from randomization.
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