Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical Hypothesis:

It is expected that by removing chemotherapy and adding ancestim to the mobilization scheme in most of the subjects sufficient PBPC will be harvested with a minimum of toxicity and side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg Universitetshospital; Aalborg University Hospital
• Collaborators: Amgen; Helsinki University Central Hospital; Herlev Hospital; Nordic Lymphoma Group; Oslo University Hospital; Rigshospitalet, Denmark; Turku University Hospital; Umeå University; University Hospital, Linkoeping
• Treatments: Lenograstim

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