# A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies

> **NCT00343798** · PHASE1 · COMPLETED · sponsor: **Fred Hutchinson Cancer Center** · enrollment: 23 (actual)

## Conditions studied

- Accelerated Phase Chronic Myelogenous Leukemia
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- 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 Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Burkitt Lymphoma
- Childhood Chronic Myelogenous Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia
- Contiguous Stage II Adult Burkitt Lymphoma
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 3 Follicular Lymphoma
- Contiguous Stage II Mantle Cell Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Prolymphocytic Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic 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 Small Lymphocytic Lymphoma
- Refractory Anemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Chronic Lymphocytic Leukemia
- Refractory Multiple Myeloma
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Splenic Marginal Zone Lymphoma
- Stage I Adult Burkitt Lymphoma
- Stage I Adult Diffuse Large Cell Lymphoma
- Stage I Adult Diffuse Mixed Cell Lymphoma
- Stage I Adult Immunoblastic Large Cell Lymphoma
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Childhood Lymphoblastic Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage II Childhood Lymphoblastic Lymphoma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Stage III Adult Diffuse Mixed Cell Lymphoma
- Stage III Adult Immunoblastic Large Cell Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Stage III Childhood Lymphoblastic Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Mantle Cell Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Childhood Lymphoblastic Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma

## Interventions

- **DRUG:** cyclophosphamide
- **DRUG:** fludarabine phosphate
- **DRUG:** cyclosporine
- **DRUG:** mycophenolate mofetil
- **OTHER:** ex-vivo umbilical cord blood expansion
- **PROCEDURE:** double-unit umbilical cord blood transplantation
- **PROCEDURE:** biopsy
- **OTHER:** immunologic technique
- **OTHER:** diagnostic laboratory biomarker analysis

## Key facts

- **NCT ID:** NCT00343798
- **Lead sponsor:** Fred Hutchinson Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-04
- **Primary completion:** 2013-07
- **Final completion:** —
- **Target enrollment:** 23 (ACTUAL)
- **Last updated:** 2015-02-11

## Collaborators

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- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00343798

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00343798, "A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies". Retrieved via AI Analytics 2026-07-26 from https://api.ai-analytics.org/clinical/NCT00343798. Licensed CC0.

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