Leukemia, Myelomonocytic, ChronicPhase 1/2NCT03040401
A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML)
A Phase 1/2 study testing Cohort 1, Ceplene® and Proleukin®, Cohort 2, Ceplene® and Proleukin® and Cohort 3, Ceplene® and Proleukin® in people with Leukemia, Myelomonocytic, Chronic, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods. All subjects will be assigned to one of three consecutive cohorts, each comprising five patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelomonocytic, Chronic
- What is being tested?
- Cohort 1, Ceplene® and Proleukin®, Cohort 2, Ceplene® and Proleukin® and Cohort 3, Ceplene® and Proleukin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Feb 2017to 15 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- ≥18 years of age at the time of signing the informed consent form.
- CMML-1 with indication for treatment according to NMDSG guidelines*.
- Life expectancy of more than three months and ability to undergo routine outpatient evaluations for efficacy, safety, and compliance.
- The patient must be informed of the investigational nature of the study and written informed consent obtained and signed.
- including, but not limited to increasing WBC, transfusion dependence, B-symptoms, splenomegaly.
Who cannot join
- Acute myeloid leukemia.
- CMML-2 according to WHO criteria.
- Systemic mastocytosis.
- Previous or intended allogeneic stem cell transplantation.
- Concomitant or intended cytostatic or cytoreductive therapy other than hydroxyurea (HU) *.
- ECOG performance status ≥3.
Show all 21Show fewer
- Platelet count (TPK) <30x109/L
- NYHA class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, angina pectoris or symptomatic arteriosclerotic blood vessel disease.
- Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin.
- Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study.
- History of seizures, central nervous system disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol.
- Serum creatinine > 1.5 times the upper normal limit.
- Serum aminotransferase (AST), alanine transaminase (ALT) and bilirubin >2.0 times the upper normal limit
- Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis).
- Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history or bleeding.
- Patients requiring active treatment for hypotension.
- Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
- Patients with a history of histamine hypersensitivity, severe allergies to food or contrast media requiring treatment within the last five years.
- Pregnancy. Women of childbearing potential (WCBP) and males having intercourse with WCBP must agree to comply with using an effective contraceptive method for the duration of the treatment (WCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months).
- Nursing
- Note that treatment with HU is allowed if treatment has been ongoing for at least 3 months prior to enrollment. The use of HU is also allowed to control myeloproliferation after starting study treatment, preferably during resting periods.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Lars Möllgård, PhD, MD, +46 (0)31 3427344, lars.mollgard@vgregion.se
Olle Werlenius, PhD, MD, olle.werlenius@vgregion.se
- Recruiting
Karolinska University Hospital, Huddinge
Stockholm
Per Broliden, MD, PhD
About this study
Official title: A Phase I/II, Open-Label, Multicenter Study of the Safety, Efficacy and Immune Response of Histamine Dihydrochloride and Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)
Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods.
All subjects will be assigned to one of three consecutive cohorts, each comprising five patients.
Read more
Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the assessment of short-term impact of HDC alone on clonal and immunological markers. For all remaining cycles the combination of HDC and IL-2 will be given.
Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical response and toxicity will be evaluated. On the basis of the results for the first 4 cycles of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the combination of HDC/IL-2 or HDC alone.
In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10 cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a family member/significant other will be instructed to administer injections of both study drugs to allow safe treatment at home.
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Being tested
- Cohort 1, Ceplene® and Proleukin®, Cohort 2, Ceplene® and Proleukin®, Cohort 3, Ceplene® and Proleukin®
- Keywords
- CMML, Ceplene, Interleukin-2
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1, Ceplene® and Proleukin®Drug
Patients in Cohort 1 will be administered only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
Cohort 2, Ceplene® and Proleukin®Drug
Patients in Cohort 2 will be administered Ceplene® in combination with Proleukin® during all treatment cycles 1-4.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
Cohort 3, Ceplene® and Proleukin®Drug
Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Ceplene® and Proleukin® | Experimental | Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 1 will receive only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4. Receives: Drug: Cohort 1, Ceplene® and Proleukin® |
| Cohort 2: Ceplene® and Proleukin® | Experimental | Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 2 will receive Ceplene® in combination with Proleukin® during all treatment cycles (1-4). Receives: Drug: Cohort 2, Ceplene® and Proleukin® |
| Cohort 3: Ceplene® and Proleukin® | Experimental | Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections.
Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2. Receives: Drug: Cohort 3, Ceplene® and Proleukin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events as defined by CTCAE v4.03.
Measured: 3 weeks after last treatment cycle
Secondary outcomes (8)
Disease progression according to IWG criteria for MDS/MPN
Measured: 3 weeks after last treatment cycle
Percentage of blasts in peripheral blood
Percentage of blasts (CD34+ cells and promonocytes) will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
Measured: 3 weeks after last treatment cycle
Percentage of monocytes in peripheral blood
Percentage of CD14+ monocytes will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
Measured: 3 weeks after last treatment cycle
Number of treated patients that transform to AML
Measured: 2 years after last treatment cycle
Percentage of circulating NK cells i peripheral blood
Percentage of NK cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
Measured: 3 weeks after last treatment cycle
Percentage of circulating CD4+ T cells i peripheral blood
Percentage of CD4+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
Measured: 3 weeks after last treatment cycle
Percentage of circulating CD8+ T cells i peripheral blood
Percentage of CD8+ T cells in peripheral blood will be assessed by flow cytometry. End-of-treatment percentage will be compared to values pre-study.
Measured: 3 weeks after last treatment cycle
Proportion of participants with overall survival at 2 years.
Measured: 2 years after last treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelomonocytic, ChronicStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital, Karolinska University Hospital, Nordic MDS Group
- Responsible party
- Sponsor
- Investigators
- Lars Möllgård, PhD, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040401
- Sponsor's protocol ID
- NMDSG14A
- Status last verified
- Dec 2017
- First submitted
- 24 Jan 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multicenter Study of the Safety, Efficacy and Immune Response of Histamine Dihydrochloride and Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)
- ClinicalTrials.gov ID
- NCT03040401
- Acronym / sponsor ID
- NMDSG14A
- Conditions
- Leukemia, Myelomonocytic, Chronic
- Keywords
- CMML, Ceplene, Interleukin-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Sahlgrenska University Hospital, Karolinska University Hospital, Nordic MDS Group
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods.
All subjects will be assigned to one of three consecutive cohorts, each comprising five patients.
Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the assessment of short-term impact of HDC alone on clonal and immunological markers. For all remaining cycles the combination of HDC and IL-2 will be given.
Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical response and toxicity will be evaluated. On the basis of the results for the first 4 cycles of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the combination of HDC/IL-2 or HDC alone.
In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10 cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.
IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a family member/significant other will be instructed to administer injections of both study drugs to allow safe treatment at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Ceplene® and Proleukin® | Experimental | Drug: Cohort 1, Ceplene® and Proleukin®Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections. Cohort 1 will receive only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4. |
| Cohort 2: Ceplene® and Proleukin® | Experimental | Drug: Cohort 2, Ceplene® and Proleukin®Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections. Cohort 2 will receive Ceplene® in combination with Proleukin® during all treatment cycles (1-4). |
| Cohort 3: Ceplene® and Proleukin® | Experimental | Drug: Cohort 3, Ceplene® and Proleukin®Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3 week rest periods for a total of 4 treatment cycles. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2 injections. Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age at the time of signing the informed consent form.
- CMML-1 with indication for treatment according to NMDSG guidelines*.
- Life expectancy of more than three months and ability to undergo routine outpatient evaluations for efficacy, safety, and compliance.
- The patient must be informed of the investigational nature of the study and written informed consent obtained and signed.
Key exclusion criteria (21 listed)
- Acute myeloid leukemia.
- CMML-2 according to WHO criteria.
- Systemic mastocytosis.
- Previous or intended allogeneic stem cell transplantation.
- Concomitant or intended cytostatic or cytoreductive therapy other than hydroxyurea (HU) *.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1, Ceplene® and Proleukin®Patients in Cohort 1 will be administered only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. | Drug | Cohort 1: Ceplene® and Proleukin® |
| Cohort 2, Ceplene® and Proleukin®Patients in Cohort 2 will be administered Ceplene® in combination with Proleukin® during all treatment cycles 1-4. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. | Drug | Cohort 2: Ceplene® and Proleukin® |
| Cohort 3, Ceplene® and Proleukin®Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2. IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. | Drug | Cohort 3: Ceplene® and Proleukin® |
Primary outcome
Adverse events as defined by CTCAE v4.03.
Time frame: 3 weeks after last treatment cycle
8 secondary outcomes
Disease progression according to IWG criteria for MDS/MPN
Time frame: 3 weeks after last treatment cycle
Percentage of blasts in peripheral blood
Time frame: 3 weeks after last treatment cycle
Percentage of monocytes in peripheral blood
Time frame: 3 weeks after last treatment cycle
Number of treated patients that transform to AML
Time frame: 2 years after last treatment cycle
Percentage of circulating NK cells i peripheral blood
Time frame: 3 weeks after last treatment cycle
Percentage of circulating CD4+ T cells i peripheral blood
Time frame: 3 weeks after last treatment cycle
Percentage of circulating CD8+ T cells i peripheral blood
Time frame: 3 weeks after last treatment cycle
Proportion of participants with overall survival at 2 years.
Time frame: 2 years after last treatment cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Möllgård, PhD, MD principal investigator
Sahlgrenska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cohort 1, Ceplene® and Proleukin®, Cohort 2, Ceplene® and Proleukin® and Cohort 3, Ceplene® and Proleukin® in people with Leukemia, Myelomonocytic, Chronic, run by Vastra Gotaland Region at 2 sites in Sweden.
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 5 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Möllgård, PhD, MD (+46 (0)31 3427344, lars.mollgard@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events as defined by CTCAE v4.03. (time frame: 3 weeks after last treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.