Phase 2
Completed N=303
Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Blood Cancer · leukemia
Source: ClinicalTrials.gov NCT00185640 ↗
Enrolled (actual)
303
Serious AEs
45.5%
Results posted
Oct 2017
Primary outcomePrimary: Acute Graft vs Host Disease (GvHD) — 2.7 percentage of participants
Summary
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Graft vs Host Disease (GvHD) |
2.7 | — |
| SECONDARY Acute Graft vs Host Disease (GvHD), All Evaluable |
11 | — |
| SECONDARY Incidence of Relapse |
53 | — |
| SECONDARY Overall Survival (OS) |
70; 64 | — |
| SECONDARY Event-free Survival (EFS) |
44; 38 | — |
| SECONDARY Transplant-related Mortality |
6 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include:
- Indolent advanced stage non-Hodgkin lymphomas
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Hodgkin disease (Hodgkin's lymphoma)
- Acute leukemias in complete remission
- Aplastic anemia
- Paroxysmal nocturnal hemoglobinuria
- Myelodysplastic or myeloproliferative syndromes.
- Other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.
- Age > 50 years, or if 3 mg/dL
- Transaminases > 4 x the upper limit of normal
- Creatinine clearance < 50 cc/min (24-hour urine collection)
- Karnofsky performance score < 60%
- Poorly controlled hypertension on multiple antihypertensives
- Documented fungal disease that is progressive despite treatment
- HIV-positive. Other viral infections, ie, Hepatitis B- and C- positive, evaluated on a case-by-case basis
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Data sourced from ClinicalTrials.gov (NCT00185640). 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. Informational only — not medical advice.