Phase 2
N=47
A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
Hematological Malignancies · Leukemia · Lymphoma · Multiple Myeloma · Hodgkin's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01315132 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Patients With Overall Survival — 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Matched Sibling Allogeneic Transplantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Overall Survival |
41 | — |
| SECONDARY Graft Versus Host Disease (GVHD) |
6; 4; 36 | — |
Summary
This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to increase overall survival.
Eligibility Criteria
Inclusion Criteria
- Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. Patients will be considered high-risk if they have any of the following:
- Age > 50 years
- ECOG Performance status of 45%
- DLCO (adjusted for hemoglobin) >45% of predicted
- Adequate liver function as defined by a serum bilirubin 60 ml/min
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent
Exclusion Criteria
- ECOG performance status of 3 or 4.
- HIV positive
- Active involvement of the central nervous system with malignancy
- Psychiatric disorder that would preclude patients from signing an informed consent
- Pregnancy
- Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder.
Data sourced from ClinicalTrials.gov (NCT01315132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.