Trial Outcomes & Findings for Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (NCT NCT03041636)

Last Updated: 2021-04-21

Results Overview

Clinical response will be assessed based on physical examination, complete blood count (CBC), a bone marrow aspiration, a whole body CT scan to be done at screening and 6 + 2 months in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines (Hallek et al., 2008)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 6 months after initiation of therapy

Results posted on

2021-04-21

Participant Flow

Recruitment Period: March 2017 to June 2019

Participant milestones

Participant milestones
Measure	Treatment (Ruxolitinib Phosphate) Patients receive ruxolitinib phosphate PO twice a daily (BID). Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ruxolitinib Phosphate) n=1 Participants Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 6 months after initiation of therapy

Outcome measures

Outcome measures
Measure	Treatment (Ruxolitinib Phosphate) n=1 Participants Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Participants With a Clinical Response	0 Participants

PRIMARY outcome

Timeframe: 6 months after initiation of therapy

Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.

Outcome measures

Outcome measures
Measure	Treatment (Ruxolitinib Phosphate) n=1 Participants Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Number of Participants With Change of Tumor Burden	0 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Response Rate is Complete Response (CR) or Partial Response (PR). CR is absence of Lymphadenopathy, Hepatomegaly or Splenomegaly, lymphocytes \< 4000/ul, normocellular, \<30% lymphocytes, no B-lymphoid nodules, Platelets \> 100,000/ul, hemoglobin \>11.0 g/dl and Neutrophils \>1500/ul. PR is \>/= 50% decrease in lymphadenopathy, hepatomegaly, splenomegaly and Blood Lymphocytes from baseline, 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count \> 100,000/ul, Hemoglobin \> 11 g/dl and Neutrophils \>1500/ul or increase \>/= 50% of all over base.

Outcome measures

Outcome measures
Measure	Treatment (Ruxolitinib Phosphate) n=1 Participants Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Participants With a Response	0 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Number of months to subsequent therapy per patient.

Outcome measures

Outcome measures
Measure	Treatment (Ruxolitinib Phosphate) n=1 Participants Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Time to Next Treatment	0 Months

Adverse Events

Treatment (Ruxolitinib Phosphate)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Ruxolitinib Phosphate) n=1 participants at risk Patients receive ruxolitinib phosphate PO BID. Treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Treatment beyond 3 years may be permitted after discussion with the principal investigator. Ruxolitinib: Given PO Ruxolitinib Phosphate: Given PO
Infections and infestations Skin Infection	100.0% 1/1 • Number of events 1 • Up to 3 years
Infections and infestations Upper Respiratory Infection	100.0% 1/1 • Number of events 1 • Up to 3 years

Additional Information

Zeev Extrov MD./Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-794-1675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place