# Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

> **NCT01529827** · PHASE2 · COMPLETED · sponsor: **Roswell Park Cancer Institute** · enrollment: 94 (actual)

## Conditions studied

- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- 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)
- Adult Grade III Lymphomatoid Granulomatosis
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Aplastic Anemia
- Burkitt Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Chronic Myelogenous Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Grade III Lymphomatoid Granulomatosis
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Chronic Myelomonocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Congenital Amegakaryocytic Thrombocytopenia
- Diamond-Blackfan Anemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Juvenile Myelomonocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Paroxysmal Nocturnal Hemoglobinuria
- Peripheral T-cell Lymphoma
- Polycythemia Vera
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- Primary Myelofibrosis
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hairy Cell Leukemia
- Refractory Multiple Myeloma
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Secondary Myelofibrosis
- Severe Combined Immunodeficiency
- Severe Congenital Neutropenia
- Shwachman-Diamond Syndrome
- Splenic Marginal Zone Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Waldenstrom Macroglobulinemia
- Wiskott-Aldrich Syndrome

## Interventions

- **DRUG:** fludarabine phosphate
- **DRUG:** melphalan
- **RADIATION:** total-body irradiation
- **DRUG:** tacrolimus
- **DRUG:** mycophenolate mofetil
- **DRUG:** methotrexate
- **OTHER:** laboratory biomarker analysis
- **PROCEDURE:** allogeneic hematopoietic stem cell transplantation
- **PROCEDURE:** peripheral blood stem cell transplantation

## Key facts

- **NCT ID:** NCT01529827
- **Lead sponsor:** Roswell Park Cancer Institute
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-02-28
- **Primary completion:** 2015-05-28
- **Final completion:** 2019-08-29
- **Target enrollment:** 94 (ACTUAL)
- **Last updated:** 2019-09-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01529827

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01529827, "Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01529827. Licensed CC0.

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