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Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 2NCT03041636

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

A Phase 2 study testing Ruxolitinib and Ruxolitinib Phosphate in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Untreated Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ruxolitinib and Ruxolitinib Phosphate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
8 Mar 2017to 29 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are able to understand and sign an informed consent document.
  • Subjects 18 years of age or older.
  • Subjects must be diagnosed with CLL/SLL and do not meet the IWCLL criteria for treatment
  • Patients should be previously untreated or have only been treated with single agent ibrutinib therapy for a period of < 3 months and were deemed ibrutinib intolerant.
  • Patients whose expected time to CLL/SLL treatment, according to our nomogram posted on the leukemia protocol priority list, is four years of less.
  • Subjects with hemoglobin values at the screening visit equal to or greater than 12.0 g/dL.
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  • Subjects with a platelet count of at least 100 x10^9 at the screening visit.
  • Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0.5 x10^9 at the screening visit.
  • Subject who are willing to undergo a bone marrow aspiration and biopsy and CT scan for disease burden assessment.
  • Patient who are capable to return to MD Anderson Cancer Center (MDACC) for follow-up
  • Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Patient must be capable of swallowing the Ruxolotinib capsules (tablets).

Who cannot join

  • Females who are pregnant or are currently breastfeeding.
  • Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening including 30 days after discontinuation of the study drug) to avoid becoming pregnant or fathering a child. A) Females of non-childbearing potential are defined as women who (a) are equal to or greater than 55 years of age with history of amenorrhea for 1 year, OR (b) are surgically sterile for at least 3 months. B) For females of childbearing potential, or for males, appropriate precautions are those that are at least 99% effective in preventing the occurrence of pregnancy. These methods should be communicated to the subjects and their understanding confirmed: a) Double barrier methods; b) Condom with spermicide in conjunction with use of an intrauterine device (IUD); c) Condom with spermicide in conjunction with use of a diaphragm; d) Oral, injectable, or implanted contraceptives; e) Tubal ligation or vasectomy (surgical sterilization)
  • Subjects with recent history of inadequate bone marrow reserve as demonstrated by previous transfusions except for acute blood loss (e.g. surgery) in the month prior to screening.
  • Subjects with inadequate liver or renal function at screening and baseline visits: A) Alanine aminotransferase (ALT) > 2.5x Upper limit of normal (ULN). B) Modification of Diet in Renal Disease (MDRD) calculated GFR < 30 mL/min
  • Subjects with active uncontrolled infection or who are HIV positive (Subjects with acute infections requiring treatment should delay screening/enrollment until the course of therapy has been completed and the event is considered controlled).
  • Subjects with a history of or a current malignancy except for treated basal or squamous carcinomas of the skin completely resected.
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  • Subjects with clinically significant uncontrolled cardiac disease.
  • Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John's wort, and potent CYP3A4 inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient. Refer to protocol section 2.2.12 for more details.
  • Subjects who have previously received JAK inhibitor therapy
  • Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements.
  • Subjects with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
  • Subjects who have unknown transfusion history.
  • Patients who cannot comply with the study requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Administration of Jakafi (Ruxolitinib) to Patients With Previously Untreated High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): A Phase II Clinical Trial

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Ruxolitinib, Ruxolitinib Phosphate
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RuxolitinibDrug

    Also called INCB-18424, INCB18424, Oral JAK Inhibitor INCB18424

    Given PO

  • Ruxolitinib PhosphateDrug

    Also called INCB-18424 Phosphate, Jakafi

    Given PO

Study groups in NCT03041636
Study groupRoleWhat they receive
Treatment (ruxolitinib phosphate)ExperimentalPatients 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.
Receives: Drug: Ruxolitinib; Drug: Ruxolitinib Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 6 months after initiation of therapy

  2. 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.

    Measured: 6 months after initiation of therapy

  3. 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.

    Measured: Up to 30 days

  4. Time to Next Treatment

    Number of months to subsequent therapy per patient.

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2017 (estimated)
  2. Study start8 Mar 2017
  3. Primary completion29 Apr 2020
  4. Study completion29 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041636
Sponsor's protocol ID
2015-0570
Other IDs
NCI-2017-00478, 2015-0570
Status last verified
Mar 2021
First submitted
1 Feb 2017
Last updated
21 Apr 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib and Ruxolitinib Phosphate in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Untreated Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With a Clinical Response (time frame: Up to 6 months after initiation of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.

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