Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan (NCT NCT00496873)

Last Updated: 2023-03-29

Results Overview

Number of participants with response out of total treated participants using IWG defined 6 categories based on IWG 1999 Response Criteria for NHL of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD). CR: is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. PR: is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions. SD: participants who have achieved less than a PR but who have not developed findings consistent with progressive disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months

Results posted on

2023-03-29

Participant Flow

Recruitment Period: June 29, 2005 to July 26, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 100 participants recruited, fifteen were excluded as screen failures prior to study assignment leaving an enrollment of 85 for the study.

Participant milestones

Participant milestones
Measure	Cytoxan + Rituxan + Nipent Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Overall Study STARTED	85
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cytoxan + Rituxan + Nipent Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Overall Study Ineligible	2
Overall Study Death	2
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Evaluation of the Safety and Efficacy of Nipent, Cytoxan, and Rituxan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytoxan + Rituxan + Nipent n=85 Participants Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated after treatment in Cycles 3, 6 and 9 (1 Cycle = 21 Days), up to 7 months

Population: Two participants of the 85 enrolled were found to be ineligible following the enrollment and not treated therefore are excluded from outcome analysis. For the 83 eligible participants, five were considered inevaluable for response, but are included as non-responders in an intent-to-treat analysis.

Outcome measures

Outcome measures
Measure	Cytoxan + Rituxan + Nipent n=83 Participants Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 CR/CRu	86.8 Percentage of Participants
Participant Response Rate According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999 Overall response	91.6 Percentage of Participants

PRIMARY outcome

Timeframe: 9 cycles of 21 days, up to 7 months

Number of participants with response according to the International Working Group (IWG) anatomic criteria for assessing six categories of efficacy response or nonresponse to treatment in non-Hodgkins lymphoma (NHL): complete remission (CR), complete remission/unconfirmed (CRu), partial remission (PR), stable disease (SD), relapsed disease (RD), and progressive disease (PD). Response was assessed after 3, 6, and 9 cycles of therapy.

Outcome measures

Outcome measures
Measure	Cytoxan + Rituxan + Nipent n=83 Participants Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Number of Participants With Complete Response (CR)/Complete Response Unconfirmed (CRu) With Low-grade Lymphoma (N=83) After 6-9 Cycles of PCR Therapy	72 participants

SECONDARY outcome

Timeframe: PFS assessed 7 days prior to every cycle and then every 3 months after off-treatment for one year, every 6 months for second year, then once on third year

Progression-free survival (PFS) was defined as time from initiation of therapy to progression of disease or death, whichever occurred first. The Kaplan-Meier method was used to estimate PFS.

Outcome measures

Outcome measures
Measure	Cytoxan + Rituxan + Nipent n=83 Participants Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
3-Year Progression-Free Survival	73 percentage of participants Interval 64.0 to 83.0

Adverse Events

Cytoxan + Rituxan + Nipent

Serious events: 6 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cytoxan + Rituxan + Nipent n=83 participants at risk Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
General disorders FATIGUE	4.8% 4/83 • Number of events 4 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Musculoskeletal and connective tissue disorders MYALGIA	2.4% 2/83 • Number of events 2 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.

Other adverse events

Other adverse events
Measure	Cytoxan + Rituxan + Nipent n=83 participants at risk Cytoxan 600 mg/m\^2, Rituxan 375 mg/m\^2 and Nipent 4 mg/m\^2 on Day 1 of 21 Day Cycle.
Immune system disorders ALLERGIC REACTION	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Skin and subcutaneous tissue disorders ALOPECIA	6.0% 5/83 • Number of events 5 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Ear and labyrinth disorders AUDITORY/ EAR (OTHER)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Eye disorders BLURRED VISION	15.7% 13/83 • Number of events 13 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders CONSTIPATION	34.9% 29/83 • Number of events 29 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Respiratory, thoracic and mediastinal disorders COUGH	3.6% 3/83 • Number of events 3 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders DIARRHEA	45.8% 38/83 • Number of events 38 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Psychiatric disorders DIZZINESS	21.7% 18/83 • Number of events 18 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Eye disorders DRY EYE	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Respiratory, thoracic and mediastinal disorders DYSPNEA	25.3% 21/83 • Number of events 21 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders EDEMA, FACIAL	13.3% 11/83 • Number of events 11 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders EDEMA, LIMB	14.5% 12/83 • Number of events 12 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders FATIGUE	78.3% 65/83 • Number of events 65 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Infections and infestations FEVER NEUTROPENIC	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Infections and infestations FEVER WITHOUT NEUTROPENIA	36.1% 30/83 • Number of events 30 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Respiratory, thoracic and mediastinal disorders NOSE BLEED	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders INDIGESTION	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Infections and infestations INFECTION WITH NORMA ANC	13.3% 11/83 • Number of events 11 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders INSOMNIA	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Psychiatric disorders MEMORY IMPAIRMENT	10.8% 9/83 • Number of events 9 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Psychiatric disorders MOOD ALTERATION	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Musculoskeletal and connective tissue disorders MYALGIA	59.0% 49/83 • Number of events 49 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders NAUSEA	80.7% 67/83 • Number of events 67 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Nervous system disorders NEUROPATHY, SENSORY	20.5% 17/83 • Number of events 17 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Musculoskeletal and connective tissue disorders PAIN (BACK)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Musculoskeletal and connective tissue disorders PAIN (BONE)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Respiratory, thoracic and mediastinal disorders PAIN (CHEST/THORAX)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders PAIN (DENTAL/ TEETH)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Nervous system disorders PAIN (HEADACHE)	12.0% 10/83 • Number of events 10 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Ear and labyrinth disorders PAIN (MIDDLE EAR)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders PAIN (ORAL CAVITY)	24.1% 20/83 • Number of events 20 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders PAIN (OTHER)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders PAIN (STOMACH)	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Skin and subcutaneous tissue disorders PRURITUS/ ITCHING	4.8% 4/83 • Number of events 4 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Skin and subcutaneous tissue disorders RASH/DESQUAMATION	6.0% 5/83 • Number of events 5 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Eye disorders REDNESS OF EYES	31.3% 26/83 • Number of events 26 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
General disorders RIGORS/ CHILLS	2.4% 2/83 • Number of events 2 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Nervous system disorders SENSORY	6.0% 5/83 • Number of events 5 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Skin and subcutaneous tissue disorders SWEATING	1.2% 1/83 • Number of events 1 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.
Gastrointestinal disorders VOMITING	54.2% 45/83 • Number of events 45 • Adverse event reporting period begins upon first administration of study drug and continues until 30 calendar days after the last exposure to study drug. Treatment includes from one to nine 21-day cycles.

Additional Information

Felipe Samaniego, MD/Associate Professor, Lymphoma/Myeloma

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place