Phase 2
N=25
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
Hematologic Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT01341301 ↗Enrolled (actual)
25
Serious AEs
100.0%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT) — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Total Body Irradiation (Radiation); Donor Lymphocyte Infusion (DLI) (Biological); Cyclophosphamide (Drug); Tacrolimus (Drug); Mycophenolate mofetil (Drug); Allogeneic hematopoietic stem cell transplantation (Procedure); Laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT) |
5 | — |
| SECONDARY Pace of T-cell and B-cell Immune Recovery |
— | — |
| SECONDARY Regimen Related Toxicities Graded According to the National Cancer Institute (NCI) Common Toxicity Criteria, Version 3.0 |
— | — |
| SECONDARY Incidence and Severity of GVHD, Graded According to Standard Criteria |
— | — |
Summary
The purpose of this research study is to examine the survival of patients undergoing partially matched hematopoietic stem cell transplant (HSCT) on a new type of treatment approach, which has been developed specifically for patients who have evidence of their disease at the time of transplant. In this research study, a way of strengthening the response of the donor cells against the disease has been developed. Patients will undergo one additional day between the two steps of the transplant which may allow their donor's cells to fight the disease more effectively.
Eligibility Criteria
Inclusion Criteria
- Any patient with a hematologic malignancy with residual disease after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely or who is in 3rd or greater complete remission (CR).
Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (ie 50 %
- Diffusion capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) >50 % of predicted
- Adequate liver function as defined by a serum bilirubin 60 ml/min
- Karnofsky Performance Status of > 80% on the modified KPS tool
- Patients must be willing to use contraception if they have childbearing potential.
- Able to give informed consent
Exclusion Criteria
- Modified Karnofsky performance status (KPS) of 5 Comorbidity Points on the hematopoietic cell transplantation comorbidity index (HCT-CI) Index
- Untreated class I or II antibodies against donor HLA antigens
- HIV positive
- Active involvement of the central nervous system with malignancy
- Psychiatric disorder that would preclude patients from signing an informed consent
- Pregnancy, or unwillingness to use contraception if they have child bearing potential
- Patients with life expectancy of 2 ugm/ml
- Patients with active inflammatory processes including Tmax >101 or active tissue inflammation are excluded
- Inability to tolerate cyclophosphamide or undergo total body irradiation at the doses specified in the treatment plan
Data sourced from ClinicalTrials.gov (NCT01341301). 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.