CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Cladribine +13 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02756572
NCT02756572Phase 2Completed

A Feasibility Study of "Early" Allogeneic Hematopoietic Cell Transplantation for Relapsed or Refractory High-Grade Myeloid Neoplasms

University of Washington·interventional·Posted Apr 29, 2016·Updated Nov 8, 2021

In Brief

A Phase 2 clinical trial evaluating Cladribine, Cyclosporine, and 12 other interventions for Blasts 10 Percent or More of Bone Marrow Nucleated Cells and 8 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This clinical trial studies how well early stem cell transplantation works in treating patients with high-grade myeloid neoplasms that has come back after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor peripheral blood cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Early stem cell transplantation may result in more successful treatment for patients with high-grade myeloid neoplasms.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 29, 2016
Enrollment StartSep 22, 2016
Primary CompletionMar 1, 2020
Study CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Cladribinedrug

Given IV

Cyclosporinedrug

Given PO

Cytarabinedrug

Given IV

Filgrastimbiological

Given SC

Fludarabine Phosphatedrug

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic hematopoietic stem cell transplantation

Laboratory Biomarker Analysisother

Correlative studies

Melphalandrug

Given IV

Mitoxantrone Hydrochloridedrug

Given IV

Mycophenolate Mofetildrug

Given PO

Questionnaire Administrationother

Ancillary studies

Sirolimusdrug

Given PO

Total-Body Irradiationradiation

Undergo TBI

Melphalan Hydrochloridedrug

Given IV