Clinical trial · Interventional
G-CSF PMRD: Granulocyte Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome
Feasibility Study of Using G-CSF Stimulated Bone Marrow and In Vivo T-Cell Depletion in Patients With Hematologic Malignancies or Bone Marrow Failure Syndrome With Partially Mismatched Related Donors
NCT00228813CI-TRIAL-00029465G-CSF PMRDterminatedN/AResults postedClinicalTrials.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): lack of enrollment
Summary
Brief summary (as posted)
The purposes of this study are: * To examine the engraftment rate in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors. * To evaluate the incidence and severity of acute and chronic graft-versus-host disease in patients receiving in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donors.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte Colony Stimulating Factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Granulocyte Colony Stimulating Factor (G-CSF) stimulation
- description
- Participants will receive bone marrow from donors who undergo Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
- interventionNames
- Drug: Granulocyte Colony Stimulating Factor
Primary outcomes (3)
- measure
- Engraftment Rate
- timeFrame
- Day 45
- description
- The number of participants who received in vivo T-cell-depleted G-CSF stimulated bone marrow from partially mismatched related donor who reached engraftment by Day 45.
- measure
- Incidence of Acute Graft-versus-host Disease
- timeFrame
- Day 100
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies or bone marrow failure syndrome who are candidates for allogeneic bone marrow transplantation are eligible for this study. Hematologic malignancies indicated for transplantation: * Acute lymphoblastic leukemia (ALL) in first remission (with high risk feature), 2nd or greater remission. * Acute myeloid leukemia (AML) in first remission (with high risk feature), 2nd or greater remission. * Chronic myeloid leukemia (CML) in 2nd chronic phase or accelerated phase. * Juvenile myelomonocytic leukemia (JMML). * Myelodysplastic syndrome. * Biphenotypic leukemia in first (with high risk feature), 2nd or greater remission. * Induction failure leukemia. * Refractory relapsed leukemia. * Bone marrow failure syndrome. * Severe aplastic anemia failed immunotherapy. * Patients who do not have a 6 out of 6 matched related or unrelated donor or 4/6 and 5/6 matched cord blood will be eligible for this study. * Partially mismatched related donor availability as defined by molecular typing with 3 to 5 HLA matches. * Patients who are under 22 years of age. Exclusion Criteria: * Patients will not be excluded based on sex, racial, or ethnic background. * Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with successful outcome following bone marrow transplant utilizing the following guidelines. * Evidence of active, deep-seated, life-threatening infections for which there is no known effective therapy (certain fungal species, HIV, etc.). * Patients who have been treated for infections must have appropriate responses as documented by 2 (two) consecutive negative cultures and/or stable radiographic examinations. * Patients who have active central nervous system (CNS) leukemic disease. * Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-HCG+) or who are not practicing adequate contraception. * Patients who have had a previous hematopoietic stem cell transplant will be excluded. * Donors will be excluded if they are sensitive to E. coli-derived protein.
References
Publications (0)
Data not yet available
No reference posted for this study.