Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Who can join
18 and older, any sex, with Hematological Malignancies. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Successful Engraftment Using Cyclophosphamide Post-TransplantPrimary· Through 100 days post-transplant
Successful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant:
ANC \>/= 0.5x10e9/L for at least 3 days. Platelet engraftment \>20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
Group
Value
95% CI
Myeloablative HSCT
1.00
1.00 – 1.00
Reduced Intensity HSCT
0.93
0.86 – 1.00
Cumulative Incidence of Grade III-IV GVHDSecondary· Through 100 days post-transplant
The cumulative incidence of Grade III-IV graft-versus-host disease (GVHD) within 100 days post-transplant will be estimated; goal is less than 10%. The cumulative incidence represents the probability that a participant experiences Grade III-IV GVHD by day 100. Results will be reported as proportion/percentage/probability.
Group
Value
95% CI
Myeloablative HSCT
0.5152
0.3312 – 0.6716
Reduced Intensity HSCT
0.3111
0.1820 – 0.4493
Incidence of GVHD Unresponsive to Corticosteroids and PhotopheresisSecondary· Through 100 days post-treatment
This outcome will estimate the cumulative incidence (probability) of graft-versus-host disease (GVHD) that is considered unresponsive to corticosteroids and photopheresis within 100 days after treatment; goal is less than 15%. The cumulative incidence will be calculated as the number of participants meeting these criteria. Results will be reported as a proportion/percentage.
Group
Value
95% CI
Myeloablative HSCT
0.0625
0.0107 – 0.1838
Reduced Intensity HSCT
0.0233
0.00177 – 0.1072
Transplant-Related MortalitySecondary· 100 days post-transplant
The cumulative incidence of transplant related mortality (TRM) by day 100 post-transplant will be estimated. Assess day 100 transplant-related mortality; goal is less than 15%. TRM is defined as death that results from medical treatment rather than from the underlying disease itself. The cumulative incidence reflects the probability of TRM by day 100. The result will be reported as a proportion/percentage/probability, not an incidence rate.
Group
Value
95% CI
Myeloablative HSCT
0.0909
0.0226 – 0.2192
Reduced Intensity HSCT
0.1951
0.0904 – 0.3292
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were recorded for 100 days following transplant..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Myeloablative HSCT
Serious: 5/33 (15%)
Deaths: 3/33
Reduced Intensity HSCT
Serious: 5/45 (11%)
Deaths: 8/45
Serious adverse events (98 terms)
Reaction
System
Myeloablative HSCT
Reduced Intensity HSCT
Acute Kidney Injury - Grade 4
Renal and urinary disorders
—
—
Hypoxia - Grade 3
Respiratory, thoracic and mediastinal disorders
—
—
Hypotension - Grade 4
Cardiac disorders
—
—
Pneumonitis - Grade 3
Infections and infestations
—
—
Syncope - Grade 3
Nervous system disorders
—
—
Hyperbilirubinemia - Grade 4
Hepatobiliary disorders
—
—
Hypoxia - Grade 4
Respiratory, thoracic and mediastinal disorders
—
—
increased creatinine - Grade 4
Renal and urinary disorders
—
—
Respiratory Failure - Grade 4
Respiratory, thoracic and mediastinal disorders
—
—
Diarrhea - Grade 3
Gastrointestinal disorders
—
—
Pulmonary Infiltrates - Grade 4
Respiratory, thoracic and mediastinal disorders
—
—
Respiratory Failure - Grade 5
Respiratory, thoracic and mediastinal disorders
—
—
Sepsis - Grade 4
Infections and infestations
—
—
Acute Kidney Injury - Grade 3
Renal and urinary disorders
—
—
Adenovirus - Grade 3
Infections and infestations
—
—
altered mental status - grade 4
Psychiatric disorders
—
—
Angioedema - Grade 4
Skin and subcutaneous tissue disorders
—
—
Arterial Thrombosis - Grade 3
Vascular disorders
—
—
Atrial Fibrillation - Grade 2
Cardiac disorders
—
—
Atrial Fibrillation - Grade 3
Cardiac disorders
—
—
Atrioventricular block complete - grade 4
Cardiac disorders
—
—
BK Viremia - Grade 3
Infections and infestations
—
—
Blood bilirubin increased - Grade 3
Hepatobiliary disorders
—
—
Candidemia - Grade 3
Infections and infestations
—
—
Cardiomyopathy - Grade 3
Cardiac disorders
—
—
Other adverse events (661 terms — click to expand)
It is hypothesized that engraftment when administering cyclophosphamide post the stem cell infusion will increase, the incidence of graft versus host disease (GVHD) and day 100 mortality will decrease, and the use of cyclophosphamide post stem cell infusion with alternative donors will be as safe and as effective as traditional matched transplants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Last refreshed: 15 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01349101.