Trial Outcomes & Findings for Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies (NCT NCT00072514)

Last Updated: 2017-06-29

Results Overview

Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

At 3-4 weeks after completion of study treatment

Results posted on

2017-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Overall Study STARTED	55
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=51 Participants Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 3-4 weeks after completion of study treatment

Outcome measures

Outcome measures
Measure	Treatment n=51 Participants Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules	51 Participants

SECONDARY outcome

Timeframe: 3-4 weeks after completion of study treatment

Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)

Outcome measures

Outcome measures
Measure	Treatment n=51 Participants Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Overall and Complete Response Rates Overall	67 percentage of participants Interval 54.0 to 80.0
Overall and Complete Response Rates Complete	31 percentage of participants Interval 19.0 to 44.0

SECONDARY outcome

Timeframe: 3-4 weeks after completion of study treatment

Count of participants with grade 3/4 hematologic and non-hematologic adverse events.

Outcome measures

Outcome measures
Measure	Treatment n=51 Participants Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Hematologic and Non-hematologic Adverse Events. Hematologic Grade 3	10 Participants
Hematologic and Non-hematologic Adverse Events. Hematologic Grade 4	39 Participants
Hematologic and Non-hematologic Adverse Events. Non-Hematologic Grade 3	23 Participants
Hematologic and Non-hematologic Adverse Events. Non-Hematologic Grade 4	2 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Successful PBSC collection is only considered in those patients that attempted PBSC collection.

Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.

Outcome measures

Outcome measures
Measure	Treatment n=51 Participants Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Peripheral Blood Stem Cell Collection Attempted PBSC Collection	17 Participants
Peripheral Blood Stem Cell Collection Successful PBSC Collection	17 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=51 participants at risk Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Blood and lymphatic system disorders Neutrophils	74.5% 38/51
Blood and lymphatic system disorders Hemoglobin	35.3% 18/51
Blood and lymphatic system disorders Hemorrhage	9.8% 5/51
Infections and infestations Infection	23.5% 12/51
Blood and lymphatic system disorders Platelets	88.2% 45/51
Blood and lymphatic system disorders Thromboses	5.9% 3/51
Vascular disorders Hypotension	5.9% 3/51
General disorders Constitutional	9.8% 5/51
Gastrointestinal disorders GI	7.8% 4/51
Metabolism and nutrition disorders Matabolic/Laboratory	21.6% 11/51
Nervous system disorders Neurology	5.9% 3/51
General disorders Pain	11.8% 6/51
Respiratory, thoracic and mediastinal disorders Pulmonary	5.9% 3/51

Additional Information

Ajay Gopal

Fred Hutchinson Cancer Research Center

Phone: 206-288-2037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place