Trial Outcomes & Findings for Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT NCT03067571)

Last Updated: 2023-09-21

Results Overview

Response rate as determined by the International Working Group recommendations. Complete remission (CR): The patient must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1.0 x 109/L, platelet count \>/- 100 x 109/L, and normal bone marrow differential (\</= 5% blasts). Complete remission without platelet recovery (CRp): As per CR but platelet count \< 100 x 109/L. Partial remission (PR): CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Marrow CR: Bone marrow: \</= 5% myeloblasts and decrease by \>/= 50% over pre-treatment (MDS only). Morphologic leukemia-free state: Normal marrow differential (\<5% blasts); absolute neutrophil count and platelet counts are not considered. (AML only). Hematologic Improvement (HI): HI should be described by the number of individual, positively affected cell lines

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2023-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Daratumumab) Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days. Daratumumab: Given IV
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Daratumumab) n=7 Participants Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days. Daratumumab: Given IV
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age, Continuous	68 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Treatment (Daratumumab) n=7 Participants Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Participants With a Response	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Time from date of start of study medication until date of off study.

Outcome measures

Outcome measures
Measure	Treatment (Daratumumab) n=7 Participants Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Time on Treatment	1.1 Months Interval 0.2 to 3.0

SECONDARY outcome

Timeframe: Up to 5 years

Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Daratumumab) n=7 Participants Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Overall Survival	4.2 Months Interval 0.2 to 9.2

SECONDARY outcome

Timeframe: Up to 5 years

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Outcome measures

Outcome measures
Measure	Treatment (Daratumumab) n=7 Participants Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Progression Free Survival	1.1 Months Interval 0.2 to 3.0

Adverse Events

Treatment (Daratumumab)

Serious events: 6 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Daratumumab) n=7 participants at risk Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
Immune system disorders Angioedema	14.3% 1/7 • Number of events 1 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Number of events 1 • Up to 5 years
Investigations Febrile Neutropenia	28.6% 2/7 • Number of events 2 • Up to 5 years
Infections and infestations Infection	14.3% 1/7 • Number of events 1 • Up to 5 years
Infections and infestations Lung Infection	14.3% 1/7 • Number of events 2 • Up to 5 years
Gastrointestinal disorders Oral Mucositis	14.3% 1/7 • Number of events 1 • Up to 5 years
Investigations Neutrophil count decreased	28.6% 2/7 • Number of events 2 • Up to 5 years
Infections and infestations Pharyngitis	14.3% 1/7 • Number of events 1 • Up to 5 years
Infections and infestations Sepsis	42.9% 3/7 • Number of events 3 • Up to 5 years
Infections and infestations Septic Shock	14.3% 1/7 • Number of events 1 • Up to 5 years

Other adverse events

Other adverse events
Measure	Treatment (Daratumumab) n=7 participants at risk Patients receive daratumumab IV over 3.25-6.5 hours on days 1, 8, 15 and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Daratumumab: Given IV
General disorders Chills	14.3% 1/7 • Number of events 1 • Up to 5 years
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	42.9% 3/7 • Number of events 3 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	42.9% 3/7 • Number of events 3 • Up to 5 years
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Up to 5 years
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • Up to 5 years
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 1 • Up to 5 years
Skin and subcutaneous tissue disorders Pruritis	14.3% 1/7 • Number of events 1 • Up to 5 years
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • Up to 5 years

Additional Information

Gautam Borthakur MD/Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-563-1586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place