Trial Outcomes & Findings for Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies (NCT NCT00837200)

Last Updated: 2017-07-24

Results Overview

* Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU * Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles * MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion * Stable disease \> 2mo was a response

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

16 weeks

Results posted on

2017-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	ODD Regimen Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=13 Participants Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	64.9 years n=5 Participants
Age, Customized Participants over 70 years old	6 participants n=5 Participants
Age, Customized Partipants under 70 years old	7 participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Participants Diagnosis Multiple Myeloma	7 participants n=5 Participants
Participants Diagnosis Diffuse Large B-cell Lymphoma	6 participants n=5 Participants
Prior Regimens Pre-Treated with 3 Median prior Regimens	3 participants n=5 Participants
Prior Regimens Not treated with Prior Regimens	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	ODD Regimen n=12 Participants Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Tumor Response	2 participants

PRIMARY outcome

Timeframe: 16 Weeks

Outcome measures

Outcome measures
Measure	ODD Regimen n=12 Participants Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Study Specific Measure (Response) Not Evaluable for Response	1 participants
Study Specific Measure (Response) Stable Disease > 2 months	2 participants
Study Specific Measure (Response) Progressive Disease	10 participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	ODD Regimen n=13 Participants Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Study Specific Measure (Number of Participants Taken Off Study) Due to Oncaspar-Related Toxicities	1 participants
Study Specific Measure (Number of Participants Taken Off Study) Not De to Oncaspar-Related Toxicities	12 participants

Adverse Events

ODD Regimen

Serious events: 9 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ODD Regimen n=13 participants at risk Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Respiratory, thoracic and mediastinal disorders Pneumonia	7.7% 1/13 • Number of events 1
Renal and urinary disorders Acute Renal Failure	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Mucositis	7.7% 1/13
Metabolism and nutrition disorders Elevated Alk Phos	7.7% 1/13
Metabolism and nutrition disorders Elevated AST	7.7% 1/13
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13
Vascular disorders Pulmonary Emboli	7.7% 1/13
Infections and infestations Sepsis	7.7% 1/13
Gastrointestinal disorders Emesis	7.7% 1/13
Gastrointestinal disorders Nausea	7.7% 1/13
Gastrointestinal disorders Dehydration	15.4% 2/13 • Number of events 2
Infections and infestations Infection - unk ANC	7.7% 1/13
Infections and infestations Fever	7.7% 1/13
Gastrointestinal disorders Anorexia	7.7% 1/13

Other adverse events

Other adverse events
Measure	ODD Regimen n=13 participants at risk Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects. Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.
Blood and lymphatic system disorders Decreased WBC	53.8% 7/13
Blood and lymphatic system disorders Decreased ANC	30.8% 4/13
Metabolism and nutrition disorders Elevated AST	23.1% 3/13
Metabolism and nutrition disorders Elevated ALT	23.1% 3/13
Blood and lymphatic system disorders Decreased Platelets	46.2% 6/13
Blood and lymphatic system disorders Decreased Hemoglobin	61.5% 8/13

Additional Information

Joseph J Drabick, MD

Milton S Hershey Medical Center

Phone: 717-531-5911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place