Clinical trial · Interventional
TevaGastrim for Stem Cell Mobilization Sibling Donors
TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
NCT01542944CI-TRIAL-00021846completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TevaGastrim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TevaGastrim
- description
- treatment with TevaGastrim for allogeneic stem cell collection
- interventionNames
- Drug: TevaGastrim
Primary outcomes (1)
- measure
- Mobilisation success rate
- timeFrame
- 4 weeks
- description
- Mobilisation success rate is defined as the mobilisation of a PBSC graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach \>2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching \>5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
Secondary outcomes (2)
- measure
- engraftment after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 70 years. 2. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation 3. Written informed consent. Exclusion Criteria: 1. Inability to tolerate PBPC harvest. 2. Peripheral venous access not possible. 3. Positive pregnancy test for female donors. 4. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR. 5. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study. 6. Treatment with other investigational drugs. 7. Known sensitivity to CHO derived products. 8. HIV positive. 9. History of malignant disease or current malignancy.
References
Publications (0)
Data not yet available
No reference posted for this study.