Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Apr 10, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a new drug called itacitinib can help prevent complications after a type of stem cell transplant known as a 'mini' transplant. This transplant uses stem cells from a related donor and is aimed at patients over the age of 60 with certain types of blood cancers, such as leukemia and multiple myeloma. The study will look at if giving itacitinib before and after the transplant can reduce a serious condition called cytokine release syndrome (CRS) and shorten the time patients need to take another medicine called MMF after the transplant.

To participate in this trial, patients must have a suitable related donor and meet specific health criteria, such as having certain types of blood cancer in remission and being at least 60 years old. Participants can expect to receive close monitoring during the trial to ensure their safety and to see how well the itacitinib works in combination with the transplant. This research is important because it could lead to improved treatment options for older patients with blood cancers, helping them have a better recovery experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor.
• * Eligible diagnoses:
• • 1. Acute leukemias in complete remission with minimal residual disease
• • 2. Myelodysplastic syndrome (MDS) with at least one poor-risk feature
• • 3. Chronic myelomonocytic leukemia with at least one poor-risk feature
• • 4. T-cell PLL in PR or better prior to transplantation.
• • 5. Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase.
• • 6. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
• • 7. Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen
• • Age ≥ 60 years.
• * Adequate end-organ function as measured by:
• • 1. Left ventricular ejection fraction ≥ 35% or shortening fraction \> 25%
• • 2. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST ≤ 5 x ULN
• • 3. FEV1 and FVC ≥ 40% of predicted
• • ECOG performance status ≤ 2 or Karnofsky score ≥ 60
• Exclusion Criteria:
• • No active extramedullary leukemia or known active CNS involvement by malignancy.
• • Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning.
• • No previous allogeneic HSCT.
• • Not pregnant or breast-feeding
• • No uncontrolled infection.
• • No known HIV infection.
• • No active replicating HBV or HCV infection detected by PCR that requires treatment or at risk for HBV reactivation (positive HBsAg)