Unknown

Dataset Information

0

Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels.


ABSTRACT: Excessive adverse events were encountered in a Phase I/II study of cyclophosphamide (CY) dose deescalation in a fludarabine-based conditioning regimen for bone marrow transplantation from unrelated donors in patients with severe aplastic anemia. All patients received fixed doses of antithymocyte globulin, fludarabine, and low-dose total body irradiation. The starting CY dose was 150 mg/kg, with deescalation to 100 mg/kg, 50 mg/kg, or 0 mg/kg. CY dose level 0 mg/kg was closed due to graft failure in 3 of 3 patients. CY dose level 150 mg/kg was closed due to excessive organ toxicity (n = 6) or viral pneumonia (n = 1), resulting in the death of 7 of 14 patients. CY dose levels 50 and 100 mg/kg remain open. Thus, CY at doses of 150 mg/kg in combination with total body irradiation (2 Gy), fludarabine (120 mg/m(2)), and antithymocyte globulin was associated with excessive organ toxicity.

SUBMITTER: Tolar J 

PROVIDER: S-EPMC3677744 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

altmetric image

Publications

Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels.

Tolar Jakub J   Deeg H Joachim HJ   Arai Sally S   Horwitz Mitchell M   Antin Joseph H JH   McCarty John M JM   Adams Roberta H RH   Ewell Marian M   Leifer Eric S ES   Gersten Iris D ID   Carter Shelly L SL   Horowitz Mary M MM   Nakamura Ryotaro R   Pulsipher Michael A MA   Difronzo Nancy L NL   Confer Dennis L DL   Eapen Mary M   Anderlini Paolo P  

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20120427 7


Excessive adverse events were encountered in a Phase I/II study of cyclophosphamide (CY) dose deescalation in a fludarabine-based conditioning regimen for bone marrow transplantation from unrelated donors in patients with severe aplastic anemia. All patients received fixed doses of antithymocyte globulin, fludarabine, and low-dose total body irradiation. The starting CY dose was 150 mg/kg, with deescalation to 100 mg/kg, 50 mg/kg, or 0 mg/kg. CY dose level 0 mg/kg was closed due to graft failure  ...[more]

Similar Datasets

| S-EPMC8509585 | biostudies-literature
| S-EPMC4861234 | biostudies-literature
| S-EPMC5074865 | biostudies-literature
| S-EPMC5373094 | biostudies-literature
| S-EPMC5743624 | biostudies-literature
| S-EPMC4215312 | biostudies-literature
| S-EPMC5584518 | biostudies-literature
2021-03-31 | GSE165870 | GEO