A Phase 2 interventional study of Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant in Hematologic Malignancies, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:
Primary Objective:
The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.
Secondary Objectives:
Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 10 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Acute Leukemias.
Exclusion Criteria:
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Drug: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Overall Survival
180 days after transplantation
Time frame: Day 180
| Milestone | cyclophosphamide post BMT |
|---|---|
| Started | 10 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Screen failure | 1 |
180 days after transplantation
| Participants | cyclophosphamide post BMT |
|---|---|
| Overall Survival | 3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| cyclophosphamide post BMT | 5/8 (62.5%) | 5/8 (62.5%) | 8/8 (100%) |
| Event | cyclophosphamide post BMT |
|---|---|
| Renal FailureRenal and urinary disorders | 1/8 |
| CMVImmune system disorders | 1/8 |
| AdenovirusImmune system disorders | 1/8 |
| Acute GVHDImmune system disorders | 1/8 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/8 |
| Event | cyclophosphamide post BMT |
|---|---|
| acute GVHDImmune system disorders | 2/8 |
| Cytokine stormBlood and lymphatic system disorders | 2/8 |
| Clostridioides difficile or C-diffInfections and infestations | 2/8 |
| Human herpesvirus 6 (HHV-6)Immune system disorders | 1/8 |
| Enterococcus Faecalis UTIInfections and infestations | 1/8 |
| BC (+) Rothia mucilaginosa septicemiaInfections and infestations | 1/8 |
| CMVImmune system disorders | 1/8 |
| aspergillosisImmune system disorders | 1/8 |
| stenotrophomomas pneumoniaRespiratory, thoracic and mediastinal disorders | 1/8 |
| vancomycin-resistant enterococcus (VRE)Infections and infestations | 1/8 |
| Age, Categorical(Participants) | Cyclophosphamide Post BMT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Cyclophosphamide Post BMT |
|---|---|
| Female | 3 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Cyclophosphamide Post BMT |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Cyclophosphamide Post BMT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 2 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Cyclophosphamide Post BMT |
|---|---|
| United States | 8 |
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University of California, San Diego