Blinatumomab in Treating Patients with Pre B-Cell Acute Lymphoblastic Leukemia (ALL) and B-Cell Non-Hodgkin Lymphoma (NHL) Undergoing Stem Cell Transplant

Active:	Yes
Cancer Type:	Non-Hodgkin Lymphoma	NCT ID:	NCT03114865
Trial Phases:	Phase I Phase II	Protocol IDs:	J1713 (primary) NCI-2019-00402 CRMS-65830 IRB00125679
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Johns Hopkins University/Sidney Kimmel Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03114865

Summary

This phase Ib/II trial studies the side effects and how well blinatumomab works in treating patients with pre B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma (NHL) who undergo stem cell transplant. Blinatumomab is an antibody. Antibodies are made of proteins that the immune system uses to fight off foreign proteins such as the ones found in infectious organisms. Researchers have designed blinatumomab to engage body’s immune system to attack cells expressing CD19, a protein, which is commonly expressed on leukemia and lymphoma cells in patients with pre-B ALL or NHL. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:
I. Determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (acute lymphoblastic leukemia [ALL], non-Hodgkin’s lymphoma [NHL]). (Phase IB)
II. Determine if incorporating blinatumomab into the post-allogeneic (allo)HSCT maintenance setting for patients with B-cell (CD19+) malignancies (ALL, NHL) who were transplanted using posttransplant cyclophosphamide (Cy) platform (cyclophosphamide only on day +3 and +4 or cyclophosphamide on day +3 and +4, mycophenolate mofetil [MMF] day 1-35, tacrolimus or sirolimus from day +5) improves disease-free survival (DFS) in an expanded cohort of patients, separately for ALL and NHL cohorts. (Phase II)

SECONDARY OBJECTIVES:
I. Determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (acute lymphoblastic leukemia [ALL], non-Hodgkin’s lymphoma [NHL]). (Phase II)
II. To report non-relapse mortality (NRM). (Phase IB/II)
III. To report the progression-free survival (PFS), disease-free survival (DFS), and overall survival (OS) after transplant for all patients and according to disease type (B-precursor ALL versus NHL). (Phase IB/II)
IV. To report on minimal residual disease (MRD) status as measured by flow cytometry and/or molecular markers. The proportion of patients who convert from MRD to no MRD status after treatment will be reported. (Phase IB/II)

EXPLORATORY OBJECTIVE:
I. To examine the T cell subsets in the peripheral blood (PB) and bone marrow (BM) using multicolor flow cytometry and T cell repertoire sequencing before and after treatment with blinatumomab. (Phase IB/II)

OUTLINE:
Patients receive blinatumomab intravenously (IV) continuously on days 1-28. Patients with detectable leukemia or lymphoma before or after their stem cell transplant are eligible for a second cycle of blinatumomab IV continuously for 28 days, which begins no sooner than 42 days and no later than 70 days from day 1 of the first cycle.

After completion of study treatment, patients are followed up periodically for 2 years.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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