Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT01016795
Eligibility Criteria:
Inclusion Criteria:
* Subjects with Hodgkin's disease and non-Hodgkin lymphomas (Real classification)
* in relapse
* refractory to initial chemotherapy
* with partial response after initial therapy
* Age \> 18 years and \< 65 years
* ECOG performance status 0, 1 or 2
* Life expectancy of \> 6 months with treatment
* ANC \> or equal to 1.5 x 109/L, Platelets \> or equal to 100 x 109/L
* Serum creatinine \< or equal to 150 µmol/L, bilirubin, aspartate aminotransferase (ASAT), and alanine aminotransferase (ALAT) less than twice the upper limit defined at the investigating laboratory
* Prior to mobilization chemotherapy subject has given written informed consent, personally dated
Exclusion Criteria:
* Prior DexaBEAM or miniBEAM therapy and prior bone marrow or PBPC transplant
* Any history of seasonal or recurrent asthma within the preceding 10 years.
* Any history of anaphylactic / anaphylactoid-type event manifested by disseminated urticaria, laryngeal oedema, and / or bronchospasm (example, food, insect bites, etc.). Subjects with drug allergies, manifested solely by rash and / or urticaria, are not excluded
* Any history of angioedema or recurrent urticaria
* Clinical or microbiological evidence of infection at the date of enrollment.
* Subjects with a concurrent malignancy
* Significant non-malignant disease including documented HIV infection, uncontrolled hypertension, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within six months, myocardial infarction within the last six months, or uncontrolled atrial or ventricular cardiac arrhythmias
* Pregnant or breast feeding subjects or those of child-bearing potential who are not using adequate contraceptive precautions
* Concurrent enrollment on any other protocol using an investigational drug
* Haematopoietic growth factors administered within one week of study entry
* Subjects with a psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
* Known sensitivity to E. coli derived products
* Concurrent use of beta adrenergic blocking agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01016795
Study Brief:
Protocol Section:
NCT01016795