Clinical trial · Interventional
A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT
An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation
NCT00616954CI-TRIAL-00017600terminatedPhase 3ClinicalTrials.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): low recruitment
Summary
Brief summary (as posted)
This study is planned to evaluated whether ATG is needed in haploidentical 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 |
|---|---|---|---|
| Allogeneic Haplo-Stem Cell Transplatation (SCT) | — | UNRESOLVED | — |
| Graft Versus Host Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG-F | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- with ATG-F
- interventionNames
- Drug: ATG-F
- type
- NO_INTERVENTION
- label
- 2
- description
- control
Primary outcomes (2)
- measure
- Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
- timeFrame
- 30 days
- measure
- Day of platelet engraftment >25x10^9/L
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age 3-70 years old with a disease necessitating allogeneic SCT. 2. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching). 3. Each patient / patient's guardian must sign written informed consent. 4. Patients must have an ECOG PS ≤ 2; Creatinine \<2.0 mg/dl; Ejection fraction \>40%; DLCO \>50% of predicted; Serum bilirubin \<3 gm/dl; elevated GPT or GOT \>3 x normal values. Exclusion Criteria: 1. Not fulfilling any of the inclusion criteria. 2. Active life-threatening infection. 3. Overt untreated infection. 4. Known hypersensitivity to ATG. 5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis. 6. Pregnant or lactating women. 7. Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition). 8. Inability to comply with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.