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Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

ConditionsT-cell LymphomaGraft Versus Host DiseaseLymphoma, T-CellPeripheral T Cell LymphomaT-cell Prolymphocytic LeukemiaCutaneous T Cell LymphomaAdult T-cell Leukemia/LymphomaPrimary Cutaneous T-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonathan Brammer

About this trial

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with T-cell lymphoma [PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT

Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Adequate hematologic function defined by absolute neutrophil count (ANC) > 1000/mm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets > 50K/mm3 without transfusion for at least 3 days and hemoglobin (Hb) > 8.0 g/dL without transfusion for at least 3 days.

Adequate organ function defined by total Bilirubin < 1.5 x ULN, alanine aminotransferase (ALT) </= 3 x ULN, CKD-EPI eGFR ≥ 30 ml/min, SpO2 > 92% without supplemental oxygen.

Disqualifiers

Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (<2) in first complete remission.

Progressive disease or any other systemic therapy post-SCT (radiation allowed)

Disease progression to Ruxolitinib previously

GvHD requiring systemic therapy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ruxolitinib

    Drug

    Administered orally twice daily

  • Positron emission tomography-computed tomography

    Procedure/Surgery

    Undergo PET-CT Scan

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Treatment (ruxolitinib maintenance)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Cumulative Incidence (CI) of relapse

Relapse is defined as evidence of disease progression or recurrence based on Lugano criteria or confirmed by biopsy.

Time frame
at 1-year post-auto-SCT
2

GvHD and relapse free-survival (GRFS)

GRFS is a composite endpoint of survival without grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD (cGVHD), relapse, or death. Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to Center for International Blood and Marrow Transplant Research (CIBMTR) patients will use log-rank tests.

Time frame
at 1-year post-allo-SCT

Secondary outcomes

1

Progression-Free survival (PFS)

Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to CIBMTR patients will use log-rank tests

Time frame
At 1 and 2 years
2

Overall Survival (OS)

Will be evaluated using the Kaplan-Meier method, with median survival and probability of surviving to relevant time points reported with point estimates and 90% confidence intervals separately for each study cohort. Comparisons to CIBMTR patients will use log-rank tests.

Time frame
At 1 and 2 years
3

Cumulative incidence of grade II-IV acute GVHD (allo-SCT cohort)

Will be conducted using non-relapse mortality (NRM) as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.

Time frame
Up to 5 years
4

Cumulative incidence of chronic extensive GvHD (allo-SCT cohort)

Will be conducted using NRM as a competing risk, with estimates of cumulative incidence at various time points reported with 90% confidence intervals. Cumulative incidences will be compared to CIBMTR data using Fine-Gray analysis.

Time frame
at 1 year post-SCT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonathan Brammer

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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