Clinical trial · Interventional
GM-CSF With Post-Transplant Cyclophosphamide
Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide
- 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)
Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.
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 |
|---|---|---|---|
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Arm | Other | — | UNRESOLVED |
| Sargramostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-CSF post-transplant
- description
- Sargramostim (GM-CSF) will start on Day +5 and continue until ANC \>1000 x3 days or \>1500 x1 day. GM-CSF will be administered not less than 24 hours after the last dose of cyclophosphamide and will be given at a dose of 250mcg/m2/day as an infusion over 2 hours.
- interventionNames
- Drug: Sargramostim
- Other: Control Arm
Primary outcomes (1)
- measure
- The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.
- timeFrame
- 3 months after initial treatment
- description
- The aim of the study is to establish equivalent effectiveness of Sargramostim to a matched control cohort of G-CSF treated patients in time to achieve neutrophil (ANC \>500 x3 days) post infusion of HLA-mismatched peripheral blood haploidentical stem cells with post-transplant cyclophosphamide. Patients will be followed for 3 months following the initiation of treatment to see engraftment numbers at 20 days after initial treatment.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * Availability of 5/10 to 8/10 matched related donor * KPS \>/= 70% * CML, AML, MDS, ALL, CLL, HD, NHL, MPS/CMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center Exclusion Criteria: * Poor cardiac, pulmonary, liver, and renal function * HIV-positive * Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent * History of severe or serious allergic reaction to human GM-CSF or yeast-derived products
References
Publications (0)
Data not yet available