Phase 2
N=30
Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases
Chronic Leukemia · Acute Leukemia · Hodgkin's Disease · Non-Hodgkin's Lymphoma · Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01336712 ↗Enrolled (actual)
30
Serious AEs
43.3%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant — 30 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peripheral Blood Stem Cell Transplant (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant |
30 | — |
| SECONDARY Survival |
78 | — |
| SECONDARY Percentage of Participatns With Donor Chimerism Post-transplant |
100 | — |
| SECONDARY Disease Free Survival (DFS) Percentage |
73 | — |
| SECONDARY Non-relapsed Mortality (NRM) Percentage |
3 | — |
| SECONDARY Relapse Rate |
24 | — |
| SECONDARY Cumulative Incidence of Chronic Graft-versus-host Disease |
56 | — |
Summary
In this study, patients will receive a myeloablative preparative regimen consisting of fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All patients will receive post-transplant Cy in addition to standard post transplant immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially identical to the prior study, with the exception of the substitution of TBI for Busulfan. The investigators hypothesize that this change will significantly reduce the risk of HC, while maintaining the efficacy of the transplant.
Eligibility Criteria
Inclusion Criteria
- No available matched related or unrelated donor OR a matched related or unrelated donor that is unavailable in the time frame necessary
- Availability of a 3/6 or 5/6 matched (HLA-A, B, DR) related donor
- Donor must have a negative HLA cross-match in the host vs. graft direction
- Donor must be willing to donate mobilized peripheral blood stem cells
- Age 18 to /= 70%
- Must have one of the following high-risk malignancies
- Chronic Myelogenous Leukemia (CML) in chronic phase, resistant and/or intolerant to TKI
- CML in accelerated phase
- CML blast crisis that has entered into 2nd Chronic phase following induction
- Acute Myelogenous Leukemia (AML) in 2nd or subsequent complete remission (CR)
- AML primary induction failure but subsequently in CR
- AML in 1st CR with poor risk cytogenetics or arising from preceding hematologic disease
- AML with marrow blasts /= 10%
- Platelets /= 2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT > 3x ULN
- Poor renal function: Creatinine >/= 2.0 mg/dl or creatinine clearance (calculated creatinine clearance is permitted) < 40 mL/min based on Traditional Cockcroft-Gault formula: 140-age (yrs) x smaller of actual weight vs ideal body weight (kg)/72 x serum creatinine (mg/dl)
- HIV positive
- Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
- Prior irradiation therapy rendering patient ineligible for TBI
Data sourced from ClinicalTrials.gov (NCT01336712). 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.