AMLPhase 1NCT00684008
Safety Study of IL-7 in Recipients of a Hemopoietic Stem Cell Transplant Peripheral Blood Stem Cell Transplant
A Phase 1 study testing CYT107 - Recombinant glycosylated human interleukin 7. and rhIL-7 (CYT107) in people with AML and CML, run by Cytheris, Inc. at 1 site in United States.
Trial summary
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral blood stem transplants. Read more about this study
- Who is it for?
- Ages 15 years and older
- What is being tested?
- CYT107 - Recombinant glycosylated human interleukin 7. and rhIL-7 (CYT107)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Apr 2011
- Phase
- Phase 1
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to read consent form and give informed consent.
- At least 15 years old.
- Histologically confirmed non-lymphoid hematological malignancy.
- Recipient of T cell depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant from a 6/6 HLA (A, B, DR by intermediate resolution) identical related or unrelated donor after myeloablative conditioning.
- Received TCD HCT containing < 1x105 CD3+ T cells/kg of recipient.
- Patient included in at least one of the following categories:
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- AML in 2nd or greater complete remission.
- High-risk AML (high-risk cytogenetics, undifferentiated leukemia, secondary AML, antecedent MDS) in 1st remission.
- CML in 2nd or greater chronic phase, 2nd or greater accelerated phase.
- MDS intermediate or high risk by IPSS criteria.
- History of opportunistic infection (CMV viremia requiring anti-viral therapy, PCP pneumonia, mycobacterial infection, herpes zoster, viral respiratory infection (influenza, RSV, para-influenza), etc.
- CD4+ T cell count < 100 at 6 months post-transplant.
- At high risk for opportunistic infection (e.g., history of treated invasive fungal infection prior to the transplantation, positive CMV serology in patient, or positive toxoplasmosis serology in donor and patient, etc.).
- 60 - 210 days post transplant.
- In remission at the time of initiation of CYT107.
- Documented engraftment with sustained neutrophil counts of at least 1000/mcl and untransfused platelet counts > 20 000/mcl for 3 consecutive lab values (the last one tested <10 days before initiation of treatment) on 3 different days prior to treatment. Patients who have engrafted but require G-CSF for myelosuppressive antibiotics or antiviral medications are eligible if they require G-CSF no more than twice weekly and their ANC remains >1000/mcl.
- KPS > 60%.
- Adequate organ function:
- Cardiac: No evidence of change in cardiac function by history, exam and/or EKG post-HCT.
- Pulmonary: Absence of dyspnea or hypoxia (< 90% of saturation by pulse oxymetry on room air).
- Hepatic: Bilirubin <= 1.5 X ULN, AST (SGOT) and /or ALT (SGPT) <= 2.5 X ULN. PT/PTT < 1.5 X ULN.
- Renal: Calculated Creatinine clearance > 60 mL/min/1.73 m2. [Note: all transplant patients had an ejection fraction of > 40% on their pre-transplant echocardiogram and a DLCO > 50% of predicted (corrected for hemoglobin)]
Who cannot join
- No evidence or history of acute GVHD or of chronic GVHD.
- No recurrent leukemia post HCT.
- No active uncontrolled viral, bacterial or fungal infection.
- No documented HIV-1 or -2, HBV or HCV infection at any time before or after transplant (a positive hepatitis B serology indicative of a previous immunization is not an exclusion criteria).
- Not be receiving systemic corticosteroid, anti-mitotic agent or other immunosuppressive treatment.
- Not receiving Growth Hormone or gonadotropin agonists/ antagonists.
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- Not receiving any cytokine support other than G-CSF post-HCT.
- Not receiving concurrent treatment with another investigational drug and/or biological agent.
- Not receiving anticoagulant therapy.
- No uncontrolled hypertension.
- No history of lymphoid malignancy (e.g. Hodgkin disease, non Hodgkin lymphoma, Acute Lymphoblastic Leukemia and Chronic Lymphocytic Leukemia) or acute biphenotypic leukemia.
- No peripheral lymphadenopathy (any lymph node > 1 cm).
- No history of EBV associated lymphoproliferation.
- No EBV viremia equal to or greater than 500 copies EBV DNA/mL of blood by quantitative PCR.
- No history of autoimmune disease nor a HCT donor with a history of an autoimmune disease.
- Fertile patients must use effective birth control. Not pregnant or nursing. Negative pregnancy test within 2 weeks of study treatment.
- QTc prolongation (QTc > 470 ms) or prior history of significant arrhythmia or ECG abnormalities.
- No active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Institute
New York, New York, 10065
About this study
Official title: A Phase I Study of CYT107 (Recombinant Glycosylated Human IL-7) in Recipients of HLA Matched Ex Vivo T Cell Depleted Bone Marrow or Peripheral Blood Stem Cell Transplant
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral blood stem transplants.
The dose escalation design is aimed at establishing the absence of significant toxicity and to define a biologically active dose in this patient population.
Read more
At each dose level, eligible patients will receive 3 doses of CYT107 injected subcutaneously (under the skin of the arm, legs, or stomach) once a week for 3 weeks.
Groups of three patients will be entered at each dose level of CYT107. Three dose levels are planned: 10 mcg/kg/week, 20 mcg/kg/week and 30 mcg/kg/week. Three patients must complete day 42 of the study at a dose level without a dose limiting toxicity (DLT) before there is escalation to the next dose level.
Read the detailed description
Rationale: Delayed and deficient reconstitution of T cells and their functions are a major obstacle to the success of a hematopoietic stem cell transplant (HSCT). CYT-107 may have potential clinical use after allogeneic HSCT to enhance lymphoid reconstitution which could have a number of beneficial effects including decreased morbidity and mortality from post-transplant infections. Our preliminary data with a previous generation IL-7, CYT 99 007, raise the possibility that IL-7 could have, in some cases, an anti-GVHD effect while keeping the anti-tumor effect of the allograft intact.
Primary Objective:
- To determine the safety and a recommended dose of CYT107 (r-hIL-7) in recipients of an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant after initial engraftment and hematopoietic reconstitution.
- If toxicities are encountered, to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).
Secondary Objectives:
- To define the pharmacokinetics of escalating doses of CYT107 in recipients of allogeneic transplants.
To achieve preliminary characterization:
- Of the effects of CYT107 treatment on engraftment and GVHD.
- Of the effects of CYT107 on the recovery of T, NK and B cell populations and their functions in vitro.
- Of a tolerable biologically active range of doses for CYT107 in recipients of allogeneic transplants.
- Whether and to what degree administration of CYT107 might influence the risk of developing an EBV-lymphoproliferative disorder.
- Of the effects of CYT107 treatment on leukemia relapse.
- Being tested
- CYT107 - Recombinant glycosylated human interleukin 7., rhIL-7 (CYT107)
- Keywords
- interleukin-7, immune based therapies, graft vs host disease, immune reconstitution, infection, lymphopenia, hematopoetic stem cell transplantation, bone marrow transplantation, peripheral blood stem cell transplant, immunosuppression
- Medical subject headings
- Graft vs Host Disease, Infections, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107 - Recombinant glycosylated human interleukin 7.Drug
Also called rhIL-7
Patients will be treated with CYT107 60 to 210 days post transplantation, in 3 successive cohorts of 3 patients. Escalating doses of CYT107 will be given to successive cohorts. Patients will receive 1 dose of CYT107 by the subcutaneous route, once a week for 3 weeks. Dose level 1: 10 mcg/kg/dose for 3 doses; Dose level II: 20 mcg/kg/dose for 3 doses; Dose level III: 30 mcg/kg/dose for 3 doses. Only 1 treatment course for this initial study.
rhIL-7 (CYT107)Drug
Also called interleukin-7
10, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Single arm dose escalation study. Three successive cohorts of 3 patients each. Doses to be evaluated: 10, 20, and 30 mcg/kg/dose for 3 consecutive doses.
CYT107 is a recombinant protein belonging to the class of growth factors known as cytokines.
CYT107 is a heavily glycosylated and sialylated form of recombinant human Interleukin-7.
CYT107 is supplied as a sterile colorless liquid at a concentration of 4 mg/ml. Receives: Drug: CYT107 - Recombinant glycosylated human interleukin 7.; Drug: rhIL-7 (CYT107) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of CYT107 in post-transplant patients with AML, CML and MDS using the NCI Common Toxicity Criteria version 3.0 with the BMT specific adverse event grading system.
Measured: Visits: 2 week screening period; treatment visits on days 0, 7, and 14; non-treatment visits on Days 1, 21, 28, 42, 56, and 77.
Secondary outcomes (1)
Pharmacokinetics and Pharmacodynamics
Measured: Study days 0, 1, 7, 14, 21, 28, 42, and 77.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMar 2008
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytheris, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcel van den Brink, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684008
- Sponsor's protocol ID
- CLI-107-08
- Other IDs
- MSKCC IRB #07-127
- Status last verified
- Jul 2012
- First submitted
- 21 May 2008
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alpdogan O, Muriglan SJ, Eng JM, Willis LM, Greenberg AS, Kappel BJ, van den Brink MR. IL-7 enhances peripheral T cell reconstitution after allogeneic hematopoietic stem cell transplantation. J Clin Invest. 2003 Oct;112(7):1095-107. doi: 10.1172/JCI17865.
PubMed 14523046Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.
PubMed 16699374Perales MA, Goldberg JD, Yuan J, Koehne G, Lechner L, Papadopoulos EB, Young JW, Jakubowski AA, Zaidi B, Gallardo H, Liu C, Rasalan T, Wolchok JD, Croughs T, Morre M, Devlin SM, van den Brink MR. Recombinant human interleukin-7 (CYT107) promotes T-cell recovery after allogeneic stem cell transplantation. Blood. 2012 Dec 6;120(24):4882-91. doi: 10.1182/blood-2012-06-437236. Epub 2012 Sep 25.
PubMed 23012326
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of CYT107 (Recombinant Glycosylated Human IL-7) in Recipients of HLA Matched Ex Vivo T Cell Depleted Bone Marrow or Peripheral Blood Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00684008
- Acronym / sponsor ID
- CLI-107-08
- Keywords
- interleukin-7, immune based therapies, graft vs host disease, immune reconstitution, infection, lymphopenia, hematopoetic stem cell transplantation, bone marrow transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cytheris, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Study completion
- Apr 2011 (actual)
- First posted
- 26 May 2008 (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.
This is a phase I inter-patient dose escalation open labeled study assessing multiple doses of CYT107 in patients of at least 15 years of age, who are recipients of HLA matched ex vivo T cell depleted bone marrow or peripheral blood stem transplants.
The dose escalation design is aimed at establishing the absence of significant toxicity and to define a biologically active dose in this patient population.
At each dose level, eligible patients will receive 3 doses of CYT107 injected subcutaneously (under the skin of the arm, legs, or stomach) once a week for 3 weeks.
Groups of three patients will be entered at each dose level of CYT107. Three dose levels are planned: 10 mcg/kg/week, 20 mcg/kg/week and 30 mcg/kg/week. Three patients must complete day 42 of the study at a dose level without a dose limiting toxicity (DLT) before there is escalation to the next dose level.
Detailed description
Rationale: Delayed and deficient reconstitution of T cells and their functions are a major obstacle to the success of a hematopoietic stem cell transplant (HSCT). CYT-107 may have potential clinical use after allogeneic HSCT to enhance lymphoid reconstitution which could have a number of beneficial effects including decreased morbidity and mortality from post-transplant infections. Our preliminary data with a previous generation IL-7, CYT 99 007, raise the possibility that IL-7 could have, in some cases, an anti-GVHD effect while keeping the anti-tumor effect of the allograft intact.
Primary Objective:
- To determine the safety and a recommended dose of CYT107 (r-hIL-7) in recipients of an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant after initial engraftment and hematopoietic reconstitution.
- If toxicities are encountered, to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).
Secondary Objectives:
- To define the pharmacokinetics of escalating doses of CYT107 in recipients of allogeneic transplants.
To achieve preliminary characterization:
- Of the effects of CYT107 treatment on engraftment and GVHD.
- Of the effects of CYT107 on the recovery of T, NK and B cell populations and their functions in vitro.
- Of a tolerable biologically active range of doses for CYT107 in recipients of allogeneic transplants.
- Whether and to what degree administration of CYT107 might influence the risk of developing an EBV-lymphoproliferative disorder.
- Of the effects of CYT107 treatment on leukemia relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: CYT107 - Recombinant glycosylated human interleukin 7., Drug: rhIL-7 (CYT107)Single arm dose escalation study. Three successive cohorts of 3 patients each. Doses to be evaluated: 10, 20, and 30 mcg/kg/dose for 3 consecutive doses. CYT107 is a recombinant protein belonging to the class of growth factors known as cytokines. CYT107 is a heavily glycosylated and sialylated form of recombinant human Interleukin-7. CYT107 is supplied as a sterile colorless liquid at a concentration of 4 mg/ml. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Able to read consent form and give informed consent.
- At least 15 years old.
- Histologically confirmed non-lymphoid hematological malignancy.
- Recipient of T cell depleted bone marrow (BM) or peripheral blood stem cell (PBSC) transplant from a 6/6 HLA (A, B, DR by intermediate resolution) identical related or unrelated donor after myeloablative conditioning.
- Received TCD HCT containing < 1x105 CD3+ T cells/kg of recipient.
Key exclusion criteria (19 listed)
- No evidence or history of acute GVHD or of chronic GVHD.
- No recurrent leukemia post HCT.
- No active uncontrolled viral, bacterial or fungal infection.
- No documented HIV-1 or -2, HBV or HCV infection at any time before or after transplant (a positive hepatitis B serology indicative of a previous immunization is not an exclusion criteria).
- Not be receiving systemic corticosteroid, anti-mitotic agent or other immunosuppressive treatment.
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 |
|---|---|---|
| CYT107 - Recombinant glycosylated human interleukin 7.Also: rhIL-7Patients will be treated with CYT107 60 to 210 days post transplantation, in 3 successive cohorts of 3 patients. Escalating doses of CYT107 will be given to successive cohorts. Patients will receive 1 dose of CYT107 by the subcutaneous route, once a week for 3 weeks. Dose level 1: 10 mcg/kg/dose for 3 doses; Dose level II: 20 mcg/kg/dose for 3 doses; Dose level III: 30 mcg/kg/dose for 3 doses. Only 1 treatment course for this initial study. | Drug | I |
| rhIL-7 (CYT107)Also: interleukin-710, 20, or 30 mcg/kg once a week for 3 consecutive weeks via the subcutaneous route. | Drug | I |
Primary outcome
Toxicity of CYT107 in post-transplant patients with AML, CML and MDS using the NCI Common Toxicity Criteria version 3.0 with the BMT specific adverse event grading system.
Time frame: Visits: 2 week screening period; treatment visits on days 0, 7, and 14; non-treatment visits on Days 1, 21, 28, 42, 56, and 77.
1 secondary outcome
Pharmacokinetics and Pharmacodynamics
Time frame: Study days 0, 1, 7, 14, 21, 28, 42, and 77.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
- Background: PubMed 14523046Alpdogan O, Muriglan SJ, Eng JM, Willis LM, Greenberg AS, Kappel BJ, van den Brink MR. IL-7 enhances peripheral T cell reconstitution after allogeneic hematopoietic stem cell transplantation. J Clin Invest. 2003 Oct;112(7):1095-107. doi: 10.1172/JCI17865.
- Background: PubMed 16699374Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.
- Derived from this study: PubMed 23012326Perales MA, Goldberg JD, Yuan J, Koehne G, Lechner L, Papadopoulos EB, Young JW, Jakubowski AA, Zaidi B, Gallardo H, Liu C, Rasalan T, Wolchok JD, Croughs T, Morre M, Devlin SM, van den Brink MR. Recombinant human interleukin-7 (CYT107) promotes T-cell recovery after allogeneic stem cell transplantation. Blood. 2012 Dec 6;120(24):4882-91. doi: 10.1182/blood-2012-06-437236. Epub 2012 Sep 25.
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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.
Marcel van den Brink, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYT107 - Recombinant glycosylated human interleukin 7. and rhIL-7 (CYT107) in people with AML and CML, run by Cytheris, Inc. 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 22 inclusion and 19 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 26 Jul 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Toxicity of CYT107 in post-transplant patients with AML, CML and MDS using the NCI Common Toxicity Criteria version 3.0 with the BMT specific adverse event grading system. (time frame: Visits: 2 week screening period; treatment visits on days 0, 7, and 14; non-treatment visits on Days 1, 21, 28, 42, 56, and 77.). 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 NCT00684008, which also lists 3 linked publications.
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 26 Jul 2012.