Trials / Withdrawn
WithdrawnNCT01652014
Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies
Hematopoietic Stem Cell Transplantation Using Alternate Donor Umbilical Cord Blood Options
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Medicine and Dentistry of New Jersey · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine the safety and applicability of experimental forms of umbilical cord blood (UCB) transplantation for patients with high risk hematologic malignancies who might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a standard donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated donor (MUD)), or single UCB unit with adequate cell number and HLA-match).
Conditions
- 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 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
- Angioimmunoblastic T-cell Lymphoma
- Blastic Phase Chronic Myelogenous Leukemia
- Cutaneous B-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Noncutaneous Extranodal Lymphoma
- Peripheral T-cell Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- 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 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
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hairy Cell Leukemia
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Testicular Lymphoma
- Waldenström Macroglobulinemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cyclophosphamide | Given IV over 1 hour on Day -6; after pre-hydration |
| DRUG | fludarabine phosphate | Given IV daily over 30 minutes for 5 days (Days -6 to -2) |
| DRUG | mycophenolate mofetil | Given PO 1.0 g BID Day 1-30 |
| PROCEDURE | allogeneic hematopoietic stem cell transplantation | Undergo double-unit allogeneic UCB transplant |
| PROCEDURE | umbilical cord blood transplantation | Undergo single allogeneic UCB transplant |
| PROCEDURE | double-unit umbilical cord blood transplantation | Undergo double-unit allogeneic UCB transplant |
| RADIATION | total-body irradiation | Undergo TBI |
| DRUG | tacrolimus | Given IV 0.03 mg/kg/d as continuous infusion over 24 hours starting Day -3 with dose adjustments to maintain level of 8-20 mg/ml |
| PROCEDURE | allogeneic hematopoietic stem cell transplantation | Undergo single allogeneic UCB transplant |
| PROCEDURE | peripheral blood stem cell transplantation | Undergo irradiated allogeneic peripheral blood stem cell transplant |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2012-07-27
- Last updated
- 2016-07-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01652014. Inclusion in this directory is not an endorsement.