PTCy and Ruxolitinib GVHD Prophylaxis in Myelofibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A number of groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical and unrelated allogeneic stem cell transplantation (SCT). Still the relapse of the underlining malignancy is a problem after this prophylaxis. Ruxolitinib is currently one of the most promising drugs in the treatment of steroid-refractory GVHD. On the other hand, its primary indication is myelofibrosis, and it was demonstrated that ruxolitinib before allogeneic SCT might improve the outcome. This pilot trial evaluates whether the combination of PTCy and ruxolitinib facilitates adequate GVHD control, and decreases the risk of graft failure and disease progression in myelofibrosis patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT

NCT02627573

Leukemia, Chronic Myeloid Myelodysplastic Syndromes Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

TERMINATED PHASE2

PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity

NCT06199427

Inborn Errors of Immunity

RECRUITING PHASE2

PTCy and Ruxolitinib vs PTCy, Tacrolimus and MMF in MUD and Haploidentical HSCT

NCT04669210

Graft-versus-host-disease Stem Cell Transplant Complications Acute Myeloid Leukemia +1 more

COMPLETED PHASE2

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

NCT05622318

Graft-versus-host Disease

SUSPENDED PHASE2

Optimizing PTCy Dose and Timing

NCT03983850

Graft Versus Host Disease Hematologic Neoplasms

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Myelofibrosis Myeloproliferative Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PTCy and ruxolitinib

Group Type EXPERIMENTAL

Allogeneic hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Day 0: Infusion of unmanipulated graft

Busulfan

Intervention Type DRUG

Days -5 through -3: Busulfan 1 mg/kg po qid №10

Fludarabine monophosphate

Intervention Type DRUG

Days -7 through -2: 30 mg/m2/day iv qd x 6 days

Cyclophosphamide

Intervention Type DRUG

Day +3 and +4: 50 mg/kg/day iv qd

Ruxolitinib

Intervention Type DRUG

Days -8 through -2 15 mg tid

Ruxolitinib

Intervention Type DRUG

Days +5 through +100: 7.5 mg bid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allogeneic hematopoietic stem cell transplantation

Day 0: Infusion of unmanipulated graft

Intervention Type PROCEDURE

Busulfan

Days -5 through -3: Busulfan 1 mg/kg po qid №10

Intervention Type DRUG

Fludarabine monophosphate

Days -7 through -2: 30 mg/m2/day iv qd x 6 days

Intervention Type DRUG

Cyclophosphamide

Day +3 and +4: 50 mg/kg/day iv qd

Intervention Type DRUG

Ruxolitinib

Days -8 through -2 15 mg tid

Intervention Type DRUG

Ruxolitinib

Days +5 through +100: 7.5 mg bid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HSCT Cytoxan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have an indication for allogeneic hematopoietic stem cell transplantation
* Diagnosis:

Primary myelofibrosis Secondary myelofibrosis

* Signed informed consent
* Matched related, 8-10/10 HLA-matched unrelated or haploidentical donor available. The HLA typing is performed by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* No second tumors
* No severe concurrent illness

Exclusion Criteria

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No