# Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

> **NCT00008177** · PHASE1 · COMPLETED · sponsor: **Fred Hutchinson Cancer Center** · enrollment: 79 (actual)

## Conditions studied

- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Chronic Myelomonocytic Leukemia
- de Novo Myelodysplastic Syndromes
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Myeloid Leukemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Anemia With Ringed Sideroblasts
- Refractory Cytopenia With Multilineage Dysplasia
- Secondary Myelodysplastic Syndromes
- Untreated Adult Acute Myeloid Leukemia

## Interventions

- **RADIATION:** iodine I 131 monoclonal antibody BC8
- **RADIATION:** total-body irradiation
- **PROCEDURE:** allogeneic hematopoietic stem cell transplantation
- **PROCEDURE:** peripheral blood stem cell transplantation
- **DRUG:** fludarabine phosphate
- **DRUG:** cyclosporine
- **DRUG:** mycophenolate mofetil
- **OTHER:** laboratory biomarker analysis

## Key facts

- **NCT ID:** NCT00008177
- **Lead sponsor:** Fred Hutchinson Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 1999-07-27
- **Primary completion:** 2009-03-21
- **Final completion:** 2010-12-15
- **Target enrollment:** 79 (ACTUAL)
- **Last updated:** 2019-11-13

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00008177

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00008177, "Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT00008177. Licensed CC0.

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