Clinical trial · Interventional
Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma
A Randomized Study of Peripheral Blood Progenitor Cell Priming Comparing a Combination of r-metHuSCF and Filgrastim or Chemotherapy and Filgrastim on Mobilization and Engraftment in Patients With Relapsed or Refractory Lymphomas
NCT01016795CI-TRIAL-00018372SCF980266terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed Nov 2000 by Amgen, who stopped drug delivery
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy plus Filgrastim | Drug | — | UNRESOLVED |
| r-metHuSCF and Filgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- r-metHuSCF and Filgrastim
- description
- Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
- interventionNames
- Drug: r-metHuSCF and Filgrastim
- Drug: Chemotherapy plus Filgrastim
- type
- ACTIVE_COMPARATOR
- label
- Cyclophosphamide and Filgrastim
- description
- Patients were randomized in a 1:1 ratio to either chemotherapy combined with 10 µg/kg/d Filgrastim (control arm B), administered by subcutaneous injection for 14 days, or the combination of 10 µg/kg/d Filgrastim and SCF administered subcutaneously at a dose of 20 µg/kg/d (experimental arm A) for 8 days. Different injection sites were used for each cytokine.
- interventionNames
- Drug: r-metHuSCF and Filgrastim
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.