Phase 2
N=25
Reduced Intensity Conditioning Transplant Using Haploidentical Donors
Chronic Myelogenous Leukemia · Acute Myelogenous Leukemia · Myelodysplastic Syndrome · Acute Lymphocytic Leukemia · Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02581007 ↗Enrolled (actual)
25
Serious AEs
92.0%
Results posted
Apr 2023
Primary outcome: Primary: Graft Rejection — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Melphalan (Drug); Cyclophosphamide (Drug); peripheral blood stem cell transplant (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Graft Rejection |
3 | — |
| SECONDARY Overall Survival |
68; 56 | — |
| SECONDARY Relapse Incidence |
24; 36 | — |
| SECONDARY GVHD Incidence |
20; 8; 16; 12 | — |
Summary
This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The primary objective of the study is to estimate the incidence of graft rejection and acute GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS, chronic GVHD and EFS.
Eligibility Criteria
Inclusion Criteria
- No available matched related or unrelated donor, OR a matched related or unrelated donor will not be available in time frame necessary to perform potentially curative transplant
- Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor (donor must have negative HLA cross-match in host vs. graft direction)
- Karnofsky status ≥70%
- One of the following high-risk malignancies:
- Chronic Myelogenous Leukemia: Chronic myelogenous leukemia in chronic phase, resistant or intolerant to available tyrosine kinase inhibitors; Chronic myelogenous leukemia in accelerated phase; Chronic myelogenous leukemia with blast crisis that has entered into a second chronic phase following induction chemotherapy
- Acute Myelogenous Leukemia in first or greater remission
- Myelodysplastic Syndrome at least one of the following: treatment-related; monosmy 7, complex cytogenetics or other high risk karyotype; IPSS score of 1.0 or greater; neutropenia or cytopenia requiring transfusion not responding to therapy; peripheral or BM blast count of 2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy)
- poor renal function: Creatinine >2.0mg/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
- prior allogeneic transplant
- women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up
Data sourced from ClinicalTrials.gov (NCT02581007). 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.