A Phase 1 interventional study of Blinatumomab and Pembrolizumab in Leukemia, B-cell and Lymphoma, B-Cell, sponsored by Children's Hospital Medical Center, Cincinnati. Withdrawn at 1 site in United States. Open to participants aged 1 Year to 40 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 1, Interventional, and Treatment
This study combines the immune checkpoint inhibitor pembrolizumab with the BITE antibody blinatumomab for the treatment of relapsed/refractory pre-B cell ALL. Pembrolizumab at the proposed dosing schedule has been very well tolerated in adult studies, including elderly and unfit patients, as well as in pediatric patients. Both blinatumomab and pembrolizumab are FDA-approved for use in children as well as adults. Phase I/II trials in adult patients have demonstrated safety and activity of pembrolizumab in combination with multiple agents. In this trial, the combination of pembrolizumab and blinatumomab will be investigated for toxicity as well as possible synergy in the treatment of relapsed/refractory pre-B cell ALL.
This is a single institution investigator-initiated pilot study designed to test the safety and feasibility of combining pembrolizumab and blinatumomab immunotherapies in children, adolescents, and young adults with CD19 positive hematologic malignancies. The investigator will define the toxicity profile of the combination in two safety strata based on whether or not a patient has had a prior allogeneic hematopoietic stem cell transplant (HSCT), as they hypothesize that the immune toxicities may differ between strata. In addition, the overall response rate (CR/CRh) to this therapy will be estimated. Additional biologic correlates will be conducted to delineate the effect of the combination therapy on the patient's leukemia/lymphoma and T-cell populations and how this may influence response to therapy.
Participants who meet study eligibility will receive or continue to receive blinatumomab by continuous IV infusion for 28 days and also receive pembrolizumab (by IV infusion over 30 minutes) on day 12 of cycle 1 and day 5 of cycle 2.
One cycle lasts 35 days and patients will receive 2 cycles of therapy.
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Exclusion Criteria:
Blinatumomab and Pembrolizumab will be given for 2 cycles (each cycle lasts 35 days). Blinatumomab administered as a continuous IV infusion. Patient Weight Greater Than or Equal to 45 kg (Fixed dose) Patient Weight Less Than 45 kg (BSA-based dose) Cycle 1 (Days 1-7): Patient Weight Greater Than or Equal to 45 kg: 9 mcg/day Patient Weight Less Than 45 kg: 5 mcg/m2/day Cycle 1(Days 8-28): Patient Weight Greater Than or Equal to 45 kg: 28 mcg/day Patient Weight Less Than 45 kg: 15 mcg/m2/day Cycle 2 (Days 1-28): Patient Weight Greater Than or Equal to 45 kg: 28 mcg/day Patient Weight Less Than 45 kg: 15 mcg/m2/day Pembrolizumab: 2 mg/kg (max dose 200 mg) administered as a 30 minute IV infusion on day 12 of cycle 1 and day 5 of cycle 2.
Drug: Blinatumomab · Drug: Pembrolizumab
Continuous IV infusion
Also known as: Blincyto
IV infusion
Also known as: Keytruda
Feasibility of combining pembrolizumab and blinatumomab (dose limiting toxicities)
Number of DLTs
Time frame: 2 cycles of therapy (70 days)
Treatment related toxicities
Number of related adverse events
Time frame: 2 cycles of therapy (70 days)
Disease response
Estimate of overall response rate (CR/CRh)
Time frame: 2 cycles (70 days)
Plan to share: No
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati