drugset
drugset / Trial / NCT01652014

Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies

NCT01652014 ↗

Phase 2 Withdrawn University of Medicine and Dentistry of New Jersey National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2014-01
Primary completion
2017-01
Completion
2017-01

Outcome

Outcome not reported

Stopped (Business): “Funding unavailable”

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule 1 g Oral
Background Tacrolimus Small molecule 0.03 mg/kg Intravenous

Indications

Burkitt lymphoma Hodgkins lymphoma MALT lymphoma T-cell large granular lymphocyte leukemia Waldenstrom macroglobulinemia acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) acute myeloid leukemia with multilineage dysplasia acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, t(16;16)(p13.1;q22) adult T-cell leukemia/lymphoma adult acute lymphoblastic leukemia anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma blast phase chronic myelogenous leukemia, BCR-ABL1 positive chronic lymphocytic leukemia/small lymphocytic lymphoma extranodal nasal NK/T cell lymphoma grade III lymphomatoid granulomatosis hepatosplenic T-cell lymphoma intraocular lymphoma large-cell immunoblastic lymphoma leukemia, myeloid, accelerated-phase mantle cell lymphoma mycosis fungoides and variants myelodysplastic syndrome myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma peripheral T-cell lymphoma, not otherwise specified plasma cell myeloma post-transplant lymphoproliferative disease primary cutaneous B-cell lymphoma refractory hairy cell leukemia small intestine lymphoma splenic marginal zone lymphoma testicular lymphoma