Phase 3
Completed N=87
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
leukemia · Non-Hodgkin's Lymphoma · Diffuse Large B-Cell Lymphoma · Hematopoietic and Lymphoid Cell Neoplasm
Source: ClinicalTrials.gov NCT00075478 ↗
Enrolled (actual)
87
Serious AEs
15.3%
Results posted
May 2014
Primary outcomePrimary: Overall Survival — 65; 54 percentage of participants — p=.09
Summary
This randomized phase III trial is studying total-body irradiation (TBI) and fludarabine phosphate to see how it works compared with TBI alone followed by donor stem cell transplant in treating patients with hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening. It is not yet known whether TBI followed by donor stem cell transplant is more effective with or without fludarabine phosphate in treating hematologic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
65; 54 | .09 |
| SECONDARY Incidence of Non-relapse Mortality |
7; 9 | 0.59 |
| SECONDARY Incidence of Relapse/Progression |
40; 55 | 0.06 |
| SECONDARY Incidence of Relapse-related Mortality |
28; 37 | 0.09 |
| SECONDARY Incidence of Grades II-IV Acute GVHD |
46; 32 | 0.16 |
| SECONDARY Incidence of Chronic Extensive GVHD |
72; 48 | 0.14 |
| SECONDARY Incidence of Graft Rejection |
0; 2 | — |
| SECONDARY Progression-free Survival |
53; 36 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Patients must be not eligible for conventional allogeneic hematopoietic cell transplantation (HCT) and must have disease expected to be stable for at least 100 days without chemotherapy
- An autograft immediately prior (less than 6 months) to nonmyeloablative HCT (tandem approach) is not permitted
- Patients with hematologic malignancies treatable with HCT or with a B cell malignancy except those curable with autologous transplant will be included
- Aggressive non-Hodgkin lymphomas (NHLs) and other histologies such as diffuse large B cell NHL: patients are eligible IF they are not eligible for autologous hematopoietic stem cell transplantation (HSCT), not eligible for conventional myeloablative HSCT, or have failed an autologous HSCT
- Low grade NHL with 20% risk of disease recurrence
- Fungal infections with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than 1 month
- Patients with active bacterial or fungal infections unresponsive to medical therapy
- Karnofsky score 50 years or there is a history of anthracycline exposure or history of cardiac disease
- Poorly controlled hypertension on multiple antihypertensives
- Pulmonary: diffusion capacity of carbon monoxide (DLCO) 3 mg/dL, and symptomatic biliary disease
- DONOR: Age less than 12 years
- DONOR: Identical twin
- DONOR: Pregnancy
- DONOR: Infection with HIV
- DONOR: Known allergy to filgrastim
- DONOR: Current serious systemic illness that would result in increased risk for filgrastim mobilization and harvest of PBSC
Data sourced from ClinicalTrials.gov (NCT00075478). 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.