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Protocol Details

A Phase I Study of Subcutaneous Recombinant Human IL-15 (S.C. Rhil-15) and Alemtuzumab for Patients with Refractory or Relapsed Chronic and Acute Adult T-Cell Leukemia (ATL)

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


T-cell Lymphoproliferative Disorder;
CD4/CD25 Expressing T-cells in Blood and Lymphoid Tissues;
Anti-CD52 Monoclonal Antibody;
Antibody Dependent Cellular Cytotoxicity (ADCC)

Recruitment Keyword(s)



T-Cell Lymphoma Relapsed;
Adult T-Cell Leukemia (ATL);
Peripheral T-Cell Lymphoma (PTCL);
Cutaneous T-Cell Lymphoma (CTCL);
T-Cell Prolymphocytic Leukemia (T-PLL)

Investigational Drug(s)

Recombinant human interleukin-15 (rhIL-15)

Investigational Device(s)



Biological/Vaccine: IL-15 plus alemtuzumab

Supporting Site

National Cancer Institute


Adult T-cell leukemia (ATL) is a rare blood cancer. Researchers want to see if a combination of two drugs - recombinant human interleukin 15 (rhIL-15) and alemtuzumab - is a better treatment for ATL.


To test if giving rhIL-15 combined with alemtuzumab improves the outcome of therapy for ATL. Also, to determine the safe dose of this combination and identify side effects and effects on the immune system.


Adults 18 years and older with chronic or acute ATL who have not been helped by other treatments.


Participants will be screened with tests that are mostly part of their usual cancer care. They will sign a separate consent form for this.

Weeks 1 and 2: Participants will have a total of 10 visits. They will:

-Get rhIL-15 under the skin by needle.

-Have a physical exam and vital signs measured.

-Give blood samples.

-Answer questions about their health and their medicines.

Week 3: Participants will stay in the clinic. They will:

-Get alemtuzumab infusions in a vein through a small catheter on days 1, 2, 3, and 5..

-Take medicines to decrease side effects.

-Have a computed tomography (CT) scan to evaluate the treatment.

-Have a physical exam and vital signs measured.

-Give blood samples.

Answer questions about their health and medicines.

Weeks 4, 5, and 6 will repeat week 3, without the CT scan. Some patients will just have outpatient visits these weeks.

After treatment, participants will have follow-up visits every few months for up to 2 years. At these visits, participants will give blood samples and have CT scans.

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Inclusion Criteria

-Age greater than or equal to 18 years; no upper age limit.

-Patients diagnosed with a leukemia or lymphoma as follows:

--Chronic or acute leukemia forms of HTLV-1 associated adult T-cell leukemia;

--Peripheral T-cell lymphoma (angioimmunoblastic, hepatosplenic, or not otherwise specified); or,

--Cutaneous T-cell lymphoma stage III or IV with circulating monoclonal cells (B1 or B2) and/or erythrodermia (T4)

--T-cell prolymphocytic leukemia (T-PLL)

NOTE: Diagnosis must be validated by the Pathology Department, NCI.

-Patients must have measurable or evaluable disease.

NOTE: All patients with greater than 10% abnormal CD4+ homogeneous CD3low strongly CD25+ expressing cells, or greater than 5% S(SqrRoot)(Copyright)zary cells/T-PLL, among the PBMCs in the peripheral blood will be deemed to have evaluable disease.

-Abnormal T cells must be CD52+ as assessed by flow cytometry or immunohistochemistry.

-Patients must have a life expectancy of greater than or equal to 2 months.

- Patients must have been refractory or relapsed following front line therapy for ATL; those with CTCL or PTCL who have CD30+ disease must have progressed during or after treatment with brentuximab vedotin, or are unable to receive treatment due to allergy or intolerance.

-Patients must have recovered to less than grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation or biologic therapy within 2 weeks prior to beginning treatment. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).

-DLCO/VA and FEV 1.0 > 50% of predicted on pulmonary function tests.

-Adequate laboratory parameters, as follows:

--Serum creatinine of less than or equal to 1.5 x the upper limit of normal

--AST and ALT < 3 x the upper limit of normal

-Absolute neutrophil count greater than or equal to 1,500/mm^3 and platelets greater than or equal to 100,000/mm^3.

-ECOG less than or equal to 1.

-Patients must be able to understand and sign an Informed Consent Form.

-All patients must use adequate contraception during participation in this trial and for 4 months following completing therapy.


-Patients who have received any systemic corticosteroid therapy within 4 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), with the exception of physiological replacement doses of cortisone acetate or equivalent.

-Patients who have undergone allogeneic stem cell transplantation and have required systemic treatment for GVHD (including but not limited to oral or parenteral corticosteroids, ibrutinib, and extracorporeal phototherapy) within the last 12 weeks

-Clinical evidence of (parenchymal or meningeal) CNS involvement or metastasis. In subjects suspected of having CNS disease, a magnetic resonance imaging (MRI) scan of the brain and lumbar puncture should be done to confirm.

-Documented HIV, active bacterial infections, active or chronic hepatitis B, hepatitis C.

--Positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and HBcAb negative) or a fully resolved acute hepatitis B infection is not an exclusion criterion.

--If hepatitis C antibody test is positive, then the patient must be tested for the presence of HCV by RT-PCR and be HCV RNA negative

NOTE: HIV-positive patients are excluded from the study. Alemtuzumab may produce a different pattern of toxicities in patients with HIV infection; in addition, the depletion of T cells produced by alemtuzumab may have adverse effects on HIV-positive individuals.

- Concurrent anticancer therapy (including other investigational agents).

- History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible).

- Patients with smoldering and lymphomatous ATL.

- Pregnant or nursing patients.

- Patients who have previously received alemtuzumab are ineligible. NOTE: Patients with relapsed T-PLL who have achieved at least a partial response to prior alemtuzumab are eligible.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, moderate/severe graft versus host disease, cognitive impairment, active substance abuse, or psychiatric illness/social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Kevin C. Conlon, M.D.
National Cancer Institute (NCI)
(240) 760-6087

NCI Medical Oncology Referral Office
National Cancer Institute (NCI)

(240) 760-6050

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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