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Ruxolitinib in Combination With Autotransplant

NCT02469974 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-08-12

No results posted yet for this study

Summary

To determine the safety of the approach of giving RUXOLITINIB before and after an autologous stem cell transplant, as measured by graft failure or death.

Conditions

Interventions

DRUG

RUXOLITINIB / INC 424

Administered orally 5-20 mg twice daily x 16 weeks of therapy prior to attempted peripheral blood stem cells (PBSC) collection, during the collection and rest period and 3 months of therapy after high dose chemotherapy (HDC).

DRUG

Filgrastim

Peripheral blood stem cells (PBSC) will be mobilized with filgrastim 10 mcg/kg/day IV

DRUG

Busulfan

Conditioning for autologous Hematopoeitic Stem Cell Transplantation (HSCT) will consist of IV busulfan 2.0 mg/KBW once daily x 4 for days -5 to -2

Sponsors & Collaborators

Principal Investigators

  • Marina Kremyanskaya, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469974 on ClinicalTrials.gov