CompletedPhase 1

A Multiple Ascending Dose Study of MEDI7247 in Patients With Selected Relapsed/Refractory Hematological Malignancies

United States67 participantsStarted 2017-03-29

Plain-language summary

To assess safety and tolerability, describe the dose-limiting toxicities, determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and a recommended dose for further evaluation of MEDI7247 in patients with selected hematological malignancies who have relapsed after, or are refractory to prior standard therapy, and for whom there is no standard salvage regimen available.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
✓. Age ≥ 18 years at the time of screening.
✓. Written informed consent and any locally required authorization
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert's syndrome for which TBL ≤ 2.5 × ULN is allowed.

Exclusion criteria

✕. Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
✕. Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of MEDI7247.
✕. Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
✕. Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
✕. History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).

What they're measuring

Occurrence of adverse events (AEs)

Timeframe: From time of informed consent through 90 days post end of treatment

Occurrence of serious adverse events (SAEs)

Timeframe: From time of informed consent through 90 days post end of treatment

Occurrence of dose-limiting toxicities (DLTs)

Timeframe: During the evaluation period of 21 or 42 days post-first dose

Number of patients with changes in laboratory parameters from baseline

Timeframe: From time of informed consent and up to 21 days post end of treatment

Number of patients with changes in vital signs from baseline

Timeframe: From time of informed consent and up to 21 days post end of treatment

Number of patients with changes in electrocardiogram (ECG) results from baseline

Timeframe: From time of informed consent and up to 21 days post end of treatment

Percentage of patients with changes in laboratory parameters from baseline

Timeframe: From time of informed consent and up to 21 days post end of treatment

Trial details

NCT IDNCT03106428

SponsorMedImmune LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-03

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Confirmed relapsed/refractory diagnosis of select hematologic malignancies for which no standard/salvage therapies are available.
✓. Age ≥ 18 years at the time of screening.
✓. Written informed consent and any locally required authorization
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Liver Function Tests: AST and ALT ≤ 3 × ULN, and serum TBL ≤ 1.5 × ULN, unless consistent with Gilbert's syndrome for which TBL ≤ 2.5 × ULN is allowed.

Exclusion criteria

✕. Received cytotoxic chemotherapy within 21 days (or 42 days for nitrosureas or mitomycin C) prior to the first scheduled dose of MEDI7247.
✕. Received major surgery (as defined by the Investigator), radiotherapy, or immunotherapy (including immune checkpoint inhibitors and adoptive cellular therapy such as autologous or donor NK cell or T lymphocyte infusions (e.g. CAR -T cells)) within 28 days of the first scheduled dose of MEDI7247.
✕. Received an investigational drug within 14 days of the first scheduled dose of MEDI7247 or not recovered from associated toxicities.
✕. Patients who have previously received an autologous SCT, are excluded if less than 120 days have elapsed from the time of transplant or the patient has not recovered from transplant-associated toxicities prior to the first scheduled dose of MEDI7247.
✕. History of liver cirrhosis, liver fibrosis or prior liver irradiation regardless of the time interval (not including total body irradiation administered during allogeneic SCT).