COLUMBUS, Ohio – A new three-drug combination could help patients with aggressive forms of blood cancer achieve longer cancer remission after undergoing allogeneic (from a donor) stem cell transplantation, according to preliminary clinical trial results presented by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

For this phase I/II clinical trial, researchers evaluated a new stem cell transplant conditioning regimen designed to overcome the challenges of treating T-cell acute lymphocytic leukemia (ALL) and T-cell lymphomas. Initial study results showed that 88% of patients remained in remission one year post-treatment completion, a dramatic increase in relapse-free survival compared to the expected 45%.

“This is a critical time when the patient’s immune system is rebuilding strength to stop abnormal cell growth. What is really promising is that the addition of the drug romidepsin as maintenance post-transplant appears to both reduce cancer relapse and activate natural killer (NK) cells in the immune system to eliminate any residual cancer cells,” says Jonathan Brammer, MD, study principal investigator and a hematologist at the OSUCCC – James.

He presented these initial study results Dec. 12 at the annual meeting of the American Society of Hematology.

Study design and results

In this OSUCCC – James investigator-initiated clinical trial, hematologists enrolled 21 patients with T-cell ALL or T-cell lymphoma who were in full or partial remission but required treatment with an allogeneic stem cell transplant. All patients were under age 70 with a matched sibling or unrelated donor and were treated at either Ohio State (15 patients) or MD Anderson Cancer Center (six patients) in Houston, Texas.

Patients were given the drug romidepsin (pronounced roe-mi-dep-sin and marketed as Isotodax) in addition to the standard conditioning chemotherapy agents busulfan (pronounced bue-sul-fan and marketed as Busulfex and Myleran) and fludarabine (pronounced floo-DARE-a-been and marketed as Fludera). All patients continued to receive a maintenance dose of romidepsin every two weeks for one year post-stem cell transplant to decrease the chance of a relapse while their immune system regained strength.

T-ALL and T-cell lymphomas are rare but aggressive forms of blood cancer, and patients often relapse within a year of treatment. Dr. Brammer notes that, while stem cell transplant is the most effective treatment option available, many patients either do not reach full remission prior to undergoing the transplant or experience relapse within one year of completing transplant.

Knowing that residual disease can drive relapse, researchers designed the current clinical trial to close the window of opportunity for residual cancer cells that escaped treatment to take hold after stem cell transplantation is completed.

“We know that even when people achieve full remission, there are likely some residual cancer cells that escape treatment and allow the cancer to recur. It is very exciting to see that the addition of romidepsin as a conditioning and maintenance medication appears to dramatically decrease risk for relapse in the first year after stem cell transplantation,” says Dr. Brammer, who also is a member of the OSUCCC – James Leukemia Research Program and an associate professor in The Ohio State University College of Medicine.

Accrual for this study is nearly complete, and final results are expected in early 2023 when all patients have reached one-year follow-up.

About stem cell transplantation

Treatment with bone marrow transplant involves collecting stem cells — which are produced in the bone marrow — either from the cancer patient (autologous) or from a donor (allogeneic). Traditionally, these stem cells are then infused back into the patient after high-dose chemotherapy is completed to help restore the bone marrow’s ability to produce red and white blood cells that fight infection. T-ALL and T-cell lymphoma are forms of blood cancer that affect the body’s ability to produce healthy blood cells.To learn more about blood cancer treatment and research at the OSUCCC – James, visit cancer.osu.edu//hematology.

-30-

Media Contact: Amanda Harper
OSUCCC – James Media Relations
614-685-5420
Amanda.Harper2@osumc.edu