Phase 2
N=34
Reduced Intensity Haploidentical Transplant for Hematological Malignancies
Hematological Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT01162096 ↗Enrolled (actual)
34
Serious AEs
41.2%
Results posted
Jan 2015
Primary outcome: Primary: Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Haploidentical Allogeneic Transplantation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning |
22 | — |
| SECONDARY Number of Participants With Successful Engraftment |
31 | — |
| SECONDARY Immune Reconstitution |
35.945; 104.540; 26.50; 119.2 | — |
Summary
Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option for most patients but has been associated with poor outcomes. This study was designed to test whether using an exact amount of a donor's lymphocytes (white cells) and dividing the transplant process into 2 steps, would increase overall survival by decreasing complications. The therapy is reduced intensity so it is targeted, but not limited to, patients over the age of 65 or those who have had previous transplants.
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 must have a related donor who is a two or more allele mismatch at the HLA-A;B; C; DR loci.
- Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
- Patients must adequate organ function:
- LVEF of >45%
- DLCO >45% of predicted corrected for hemoglobin
- Adequate liver function as defined by a serum bilirubin 40 ml/min
- Performance status > 70% (Karnofsky)
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent
Exclusion Criteria
- Performance status of 2 µgm/ml.
- Patients who cannot receive cyclophosphamide
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Data sourced from ClinicalTrials.gov (NCT01162096). 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.