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Report for Clinical Trial NCT02469974

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Ruxolitinib in Combination With High Dose Therapy and Autologous Stem Cell Transplantation for Myelofibrosis

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.

NCT02469974 Myelofibrosis MF
MeSH: Primary Myelofibrosis

3 Interventions

Name: RUXOLITINIB / INC 424

Description: 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).

Type: Drug

Ruxolitinib / INC 424

Name: Filgrastim

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

Type: Drug

Ruxolitinib / INC 424

Name: Busulfan

Description: 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

Type: Drug

Ruxolitinib / INC 424


Primary Outcomes

Description: Safety of this approach as measured by graft failure or death

Measure: Safety of combining ruxolitinib with autologous HSCT measured by graft failure or death

Time: 2 years

Secondary Outcomes

Description: Total CD34+ cell dose will be calculated based on results of flow cytometric analysis and patient's weight.

Measure: CD34 cells

Time: 4 years

Measure: The regimen related mortality (RRM)

Time: day 100

Measure: The regimen related mortality (RRM)

Time: day 365

Measure: Rate of engraftment/graft failure

Time: 4 years

Measure: Time of engraftment for neutrophils and platelets

Time: 4 years

Measure: The incidence of serious infectious complications

Time: up to 1 year post transplant

Description: The myelofibrosis score will be assessed as per the European Consensus Grading published by Thiele Grading Description at 365 days as compared to 180 days

Measure: Changes in marrow fibrosis score

Time: at 180 and 365 days post-transplant

Description: Changes in FISH abnormalities when present will be measured by cytogenetics.

Measure: Change in FISH allele

Time: at 365 days post-transplant

Description: Changes in Jak 2 V617F allele burden when present will be measured by quantitative RT-PCR

Measure: Change in JAK allele

Time: at 365 days post-transplant

Description: Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease

Measure: Rate of response

Time: at 6 months post-transplant

Description: Overall efficacy will be rated on a scale as complete remission, partial remission, clinical improvement, or stable disease

Measure: Rate of response

Time: at 1 year post-transplant

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V617F

Changes in Jak 2 V617F allele burden when present will be measured by quantitative RT-PCR. --- V617F ---



HPO Nodes