A Phase 2 interventional study of Ruxolitinib and Ruxolitinib Phosphate in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Untreated Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well ruxolitinib phosphate works in treating patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the effect of ruxolitinib phosphate (ruxolitinib) in patients with high-risk chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who do not require anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations and were either previously untreated or treated with Ibrutinib for less than 3 months and were deemed Ibrutinib intolerant:
Ia. On disease burden. Ib. The rate of complete response (CR) and partial response (PR) as assessed by the IWCLL 2008 response criteria.
SECONDARY OBJECTIVES:
I. To evaluate the time to next treatment of high-risk CLL/SLL who do not require anti-neoplastic therapy according to the IWCLL 2008 recommendations.
OUTLINE:
Patients receive ruxolitinib phosphate orally (PO) twice 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.
After completion of study treatment, patients are followed up at 30 days.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
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.
Drug: Ruxolitinib · Drug: Ruxolitinib Phosphate
Given PO
Also known as: INCB-18424, INCB18424, Oral JAK Inhibitor INCB18424
Given PO
Also known as: INCB-18424 Phosphate, Jakafi
Participants With a Clinical Response
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)
Time frame: Up to 6 months after initiation of therapy
Number of Participants With Change of Tumor Burden
Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.
Time frame: 6 months after initiation of therapy
Participants With a Response
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.
Time frame: Up to 30 days
Time to Next Treatment
Number of months to subsequent therapy per patient.
Time frame: Up to 30 days
Recruitment Period: March 2017 to June 2019
| Milestone | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
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)
| Participants | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Participants With a Clinical Response | 0 |
Tumor burden will be assessed by bone marrow aspiration, whole body CT scan at screening and 6 months.
| Participants | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Number of Participants With Change of Tumor Burden | 0 |
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.
| Participants | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Participants With a Response | 0 |
Number of months to subsequent therapy per patient.
| Months | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Time to Next Treatment | 0 |
Collected over Up to 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Ruxolitinib Phosphate) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Skin InfectionInfections and infestations | 1/1 |
| Upper Respiratory InfectionInfections and infestations | 1/1 |
| Age, Categorical(Participants) | Treatment (Ruxolitinib Phosphate) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Female | 0 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Ruxolitinib Phosphate) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Ruxolitinib Phosphate) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Treatment (Ruxolitinib Phosphate) |
|---|---|
| United States | 1 |
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M.D. Anderson Cancer Center