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Lymphoblastic Leukemia, Acute, ChildhoodPhase 1NCT01614197

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

A Phase 1 study testing Temsirolimus, Etoposide and Cyclophosphamide in people with Lymphoblastic Leukemia, Acute, Childhood and Lymphoblastic Lymphoma, run by Therapeutic Advances in Childhood Leukemia Consortium at 32 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL). Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
Temsirolimus, Etoposide and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
32 sitesin 3 countries
Study dates
3 Jul 2015to 4 Sep 2020
Phase
Phase 1
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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • -Patients must be greater than or equal to 12 months and ≤ 21 years of age at the time of study enrollment.
  • Patients must have one of the following:
  • Leukemia
  • Bone marrow involvement defined as ALL ≥ 25% blasts (M2 or M3) with or without extramedullary involvement.
  • Refractory bone marrow involvement defined as MRD ≥ 0.1% blasts done at a COG-approved MRD testing lab after most recent treatment regimen. in the bone marrow (M23) and any CNS status. OR
  • Newly diagnosed patients (T or B-cell ALL) with refractory bone marrow involvement after Consolidation therapy are eligible.
Show all 48Show fewer
  • First relapse B-cell ALL patients are eligible with refractory disease.
  • Second or greater relapse B-cell patients are eligible at time of relapse or with refractory disease.
  • First or greater relapse T-cell ALL patients are eligible at time of relapse or with refractory disease.
  • Isolated CNS 2 or 3 patients with < 0.1% MRD bone marrow involvement are not eligible.
  • Lymphoma
  • Patient must have relapsed or refractory lymphoblastic lymphoma or peripheral T-cell lymphoma.
  • Patient must have histologic verification of disease at original diagnosis.
  • Patient must have evaluable or measurable disease documented by clinical or radiographic criteria or bone marrow disease present at study entry.
  • Patients may have CNS 2 or 3 disease
  • Karnofsky greater than or equal to 50% for patients > 16 years of age and Lansky greater than or equal to 50 for patients ≤ 16 years of age.
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy.
  • Patients with leukemia or lymphoma who relapse while receiving maintenance chemotherapy will not be required to have a waiting period before enrollment onto this study.
  • At least 14 days must have elapsed after the completion of cytotoxic therapy, with the exception of hydroxyurea.
  • Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor.
  • Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair
  • Immunotherapy: At least 30 days after the completion of any type of immunotherapy, e.g. tumor vaccines. or chimeric antigen receptor T cell (CART) therapy or tumor vaccines.
  • Monoclonal antibodies: At least 3 half-lives of the antibody must have elapsed after the last dose of a monoclonal antibody. (ie: Rituximab = 66 days, Epratuzumab = 69 days). Patients must have been off blinatumomab infusion for at least 4 days and all drug-related toxicity must have resolved to grade 2 or lower as outlined in the inclusion and exclusion criteria
  • XRT: At least 14 days after local palliative XRT (small port); At least 84 days must have elapsed if prior TBI, craniospinal XRT or if greater than or equal to 50% radiation of pelvis; At least 42 days must have elapsed if other substantial marrow radiation.
  • Stem Cell Infusion: No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion.
  • Adequate Bone Marrow Function Defined as: Blood counts are not required to be normal prior to enrollment on trial. However, platelet count must be greater than or equal to 20,000/mm3 to initiate therapy (may receive platelet transfusions). Patients should not be known to be refractory to red blood cell or platelet transfusions.
  • Adequate Renal Function Defined as:
  • Creatinine clearance or radioisotope GFR greater than or equal to 70ml/min/1.73 m2 or
  • Normal serum creatinine based on age and gender.
  • Adequate Liver Function Defined as:
  • Total bilirubin (sum of conjugated + unconjugated) must be less than or equal to 1.5 x normal per institutional normal values for age.
  • SGPT (ALT) and SGOT (AST) must be less than 3 x institutional upper limit of normal (Grade 1 or less per CTCAE 4).
  • --GGT must be less than 2.5 x institutional upper limit of normal (Grade 1 or less per CTCAE 4).
  • Serum albumin greater than or equal to 2 g/dL.
  • The hepatic requirements may be waived for patients with elevations clearly due to leukemic infiltration after consultation with the Study Chair or Vice Chair.
  • Fasting or non-fasting serum triglyceride level ≤ 300 mg/dL and serum cholesterol level ≤ 300 mg/dL.
  • Adequate Cardiac Function Defined As:
  • Shortening fraction of ≥ 27% by echocardiogram, or
  • Ejection fraction of ≥ 50% by gated radionuclide study.
  • Adequate Pulmonary Function Defined as:
  • Pulse oximetry > 94% on room air (> 90% if at high altitude)
  • No evidence of dyspnea at rest and no exercise intolerance.
  • Baseline chest x-ray with no evidence of active infectious disease or pneumonitis.
  • Reproductive Function
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed prior to enrollment.
  • Female patients with infants must agree not to breastfeed their infants while on this study.
  • Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study.
  • Random or fasting glucose within the upper limits of normal for age. If the initial blood glucose is non-fasting and above normal limits a fasting glucose can be obtained and must be within the upper limits of normal for age.

Who cannot join

  • Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.
  • Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible. The definition of "investigational" for use in this protocol means any drug that is not licensed by the FDA, Health Canada or the Therapeutic Goods Administration to be sold in the countries they govern. (United States, Canada and Australia)
  • Anti-cancer Agents: Patients who are currently receiving or may receive while on therapy, other anti-cancer agents, radiation therapy or immunotherapy are not eligible [except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy]. Intrathecal chemotherapy (at the discretion of the primary oncologist) may be given up to one week prior to the initiation of study therapy.
  • Anti-GVHD or agents to prevent organ rejection post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post transplant are not eligible for this trial. At least 3 half-lives must have elapsed after the last dose of GVHD meds.
  • Anticoagulants: Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible. At least 3 half-lives must have elapsed after the last dose of anticoagulants.
  • Angiotensin-converting enzyme (ACE) inhibitors: Patients who are currently receiving ACE inhibitors are not eligible due to the development of angioneurotic edema-type reactions in some subjects who received concurrent treatment with temsirolimus + ACE inhibitors. At least 3 half-lives must have elapsed after the last dose of ACE inhibitors.
Show all 19Show fewer
  • Calcium Channel Blockers: Patients who are currently receiving Calcium Channel Blockers are not eligible due to the development of angioneurotic edema-type reactions in some subjects who received concurrent treatment with temsirolimus + Calcium Channel Blockers. At least 3 half-lives must have elapsed after the last dose of Calcium Channel Blockers.
  • Enzyme inducing Anti-convulsants: Patients who are currently receiving enzyme inducing anticonvulsants (ie phenytoin, phenobarbitol, or carbamazepine) are not eligible. Stabilizing on a non-hepatic inducing metabolizing anti-convulsant (ie: gabapentin or levetiracetam) prior to study entry is acceptable. At least 3 half-lives must have elapsed after the last dose of enzyme inducing anti-coagulants.
  • Patients receiving treatment with azoles such as fluconazole or voriconazole which are potent inhibitors of temsirolimus metabolism. At least 3 half-lives must have elapsed after the last dose of azoles.
  • Patient with Burkiett's leukemia and /or lymphoma are not eligible.
  • Infection Criteria
  • Patients are excluded if they have:
  • Positive blood culture within 48 hours of study enrollment;
  • Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.
  • A positive fungal culture within 30 days.
  • Active fungal, viral, bacterial, or protozoal infection requiring IV treatment. Chronic prophylaxis therapy to prevent infections is allowed.
  • Patients with Down syndrome and Fanconi Anemia are excluded.
  • Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol treatment or required observations, interfere with consent, study participation, follow up, or interpretation of study results.
  • Patients with known optic nerve and/or retinal involvement (because it may not be possible to safely delay irradiation) are not eligible. Patients presenting with visual disturbances by history or physical exam should have an ophthalmological exam and, if indicated, an MRI to determine optic nerve or retinal involvement.

Trial locations and contacts

32 sites in 3 countries.

32 sites in 3 countries

United States25 sites

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109-0914

  • Children's Healthcare of Atlanta, Emory University

    Atlanta, Georgia, 30322

  • The Children's Hospital, University of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • Dana Farber

    Boston, Massachusetts, 02215

  • Levine Children's Hospital at Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Lurie Children's Hospital

    Chicago, Illinois

  • Rainbow Babies

    Cleveland, Ohio, 44106

  • Nationwide Childrens Hospital

    Columbus, Ohio

  • University of Texas at Southwestern

    Dallas, Texas, 75235

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • St. Jude

    Memphis, Tennessee, 38105-3678

  • University of Miami Cancer Center

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin

  • Childrens Hospital & Clinics of Minnesota

    Minneapolis, Minnesota, 55404-4597

  • Children's Hospital New York-Presbyterian

    New York, New York, 10032

  • Children's Hospital Orange County

    Orange, California

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University

    Portland, Oregon

  • Primary Children's

    Salt Lake City, Utah

  • UCSF School of Medicine

    San Francisco, California, 94143-0106

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia

Other trials in United States

Australia4 sites

  • Royal Children's Hospital

    Brisbane, Queensland

  • Royal Children's Hospital, Melbourne

    Melbourne, Victoria

  • Sydney Children's Hospital

    Sydney

  • Children's Hospital at Westmead

    Westmead, New South Wales

Other trials in Australia

Canada3 sites

  • Sainte Justine University Hospital

    Montreal, Quebec

  • Hospital for Sick Kids

    Toronto, Ontario

  • British Columbia Children's Hospital

    Vancouver

Other trials in Canada

About this study

Official title: A Phase I Trial of Temsirolimus (CCI-779, Pfizer, Inc.) in Combination With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).

Read the detailed description

Studies have shown that mTOR inhibitors (MTI) inhibit growth of pre-B and T-cell ALL cell lines in vitro and in ALL xenograft models. The MTI temsirolimus was chosen for use in this study due to its weekly intravenous dosing, its more predictable blood levels, and availability of a single-agent pediatric MTD and its sustained biologic effect due to conversion to sirolimus. This study will determine the maximum tolerated dose of temsirolimus that can given in combination with dexamethasone, cyclophosphamide and etoposide in relapsed ALL, LL or PTL. A standard 3-patient cohort dose-escalation design will be used. Response to treatment will be evaluated. Biology tests will be done to evaluate minimal residual disease (MRD), temsirolimus' effect on glucocorticoid resistance, and mTOR inhibition.

Being tested
Temsirolimus, Etoposide, Cyclophosphamide, Methotrexate, Hydrocortisone
Keywords
Relapse, Lymphoblastic, Leukemia, Refractory, Temsirolimus, Acute, Childhood, Pediatric, ALL, NHL, LL, PTL
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Peripheral, Recurrence, Leukemia

What participants receive

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

  • TemsirolimusDrug

    Also called Torisel, CCI-779

    Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.

  • EtoposideDrug

    Also called Toposar, VePesid, VP-16

    100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

    440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.

  • MethotrexateDrug

    Also called MTX, Amethopterin, Trexall

    PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.

    • Age 1 - 1.99 give 8 mg of methotrexate
    • Age 2 - 2.99 give10 mg of methotrexate
    • Age 3 - 8.99 give 12 mg of methotrexate
    • Age ≥ 9 give 15 mg of methotrexate

    PATIENTS WITH CNS 2 or 3 DISEASE

    -COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.

    COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.

    • 8 mg for patients age 1-1.99
    • 10 mg for patients age 2-2.99
    • 12 mg for patients 3-8.99 years of age
    • 15 mg for patients >9 years of age

  • HydrocortisoneDrug

    Also called Hydrocortisone sodium succinate, Solu-cortef

    Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.

    COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.

    COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.

    • 8 mg for patients age 1-1.99
    • 10 mg for patients age 2-2.99
    • 12 mg for patients 3-8.99 years of age
    • 15 mg for patients >9 years of age

  • CytarabineDrug

    Also called Cytosine arabinoside, Ara-C, Cytosar

    For Patients who are CNS1 COURSE 1: Give intrathecally to patients with CNS1 disease at the dose defined by age below on day 1 of course 1 if no other IT was given within 1 week of day 1 of course 1

    • Age 1 - 1.99 give 30 mg of Cytarabine
    • Age 2 - 2.99 give 50mg of Cytarabine
    • Age ≥ 3 give 70 mg of Cytabine

    For Patients with CNS 2 or 3 Disease COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 1 if no other IT chemotherapy given within 1 week of day 1 of course 1. Then give weekly until the patient is CNS 1 or 2 (investigator discretion). No more than 5 weekly doses to be given in cycle 1.

    COURSES 2-8: Give intrathecally to patients who were CNS 2or 3 at study entry on day 1 of each course.

    • 16 mg for patients age 1-1.99
    • 20 mg for patients age 2-2.99
    • 24 mg for patients 3-8.99 years of age
    • 30 mg for patients >9 years of age
Study groups in NCT01614197
Study groupRoleWhat they receive
Dose Level 1ExperimentalThis is the starting dose of temsirolimus at 7.5 mg/m^2 given IV. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m^2) and cyclophosphamide (440 mg/m^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.
Receives: Drug: Temsirolimus; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Hydrocortisone; Drug: Cytarabine
Dose Level 2ExperimentalIf Dose Level 1 is tolerated, the study will escalate to Dose Level 2 following the dose escalation schedule. Dose Level 2 will be administered via IV at 10 mg/m^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m^2) and cyclophosphamide (440 mg/m^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.
Receives: Drug: Temsirolimus; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Hydrocortisone; Drug: Cytarabine
Dose Level 3ExperimentalIf Dose Level 2 is tolerated, the study will escalate to Dose Level 3 following the dose escalation schedule. Dose Level 3 will be administered via IV at 15 mg/m^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m^2) and cyclophosphamide (440 mg/m^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8.
Receives: Drug: Temsirolimus; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Hydrocortisone; Drug: Cytarabine
Dose Level 4ExperimentalIf Dose Level 3 is tolerated, the study will escalate to Dose Level 4 following the dose escalation schedule. Dose Level 4 will be administered via IV at 25 mg/m^2. First dose of temsirolimus will be administered on Day 1, followed immediately by the first dose of IV etoposide and IV cyclophosphamide. Etoposide (100mg/m^2) and cyclophosphamide (440 mg/m^2) are continued for the next four days (Day 1-5). A second dose of temsirolimus is given on Day 8. Temsirolimus will not be escalated beyond Dose Level 4.
Receives: Drug: Temsirolimus; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Hydrocortisone; Drug: Cytarabine

What is being measured

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

  1. Number of Patients That Experienced DLT During Cycle 1 of Therapy

    The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. All these analyses will be descriptive and exploratory and hypotheses generating in nature.

    Measured: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)

Secondary outcomes (2)

  1. Response Rate at the Completion of 1 Cycle of Study Treatment

    CR = Complete remission defined as attainment of bone marrow with <5% blasts with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (absolute neutrophil counts (ANC) > or = to 500/uL and platelet count > or = to 50,000 microliters) CRi = Complete remission with incomplete blood count recovery defined as attainment of bone marrow with >5% blasts with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC < 500/uL or platelets < 50,000 microliters PR = partial remission defined as complete disappearance of circulating blasts and achievement of 5-25% blasts if greater than 25% blasts originally without new sites of extramedullary disease and with recovery of ANC.

    SD = stable disease defined as not satisfying criteria for PD, or has recovery of ANC > or = to 500/uL and fails to qualify for CR, CRi, or PR PD = progressive disease defined as an increase of at least 25% in bone marrow leukemic cells

    Measured: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)

  2. Minimum Residual Disease (MRD) Levels Present at End of Cycle 1 Therapy in Patients

    MRD positive is defined as > or = to 0.1% MRD MRD negative is define as < 0.1% MRD

    All these analyses will be descriptive and exploratory and hypotheses generating in nature.

    Measured: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)

Timeline

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

  1. First posted7 Jun 2012 (estimated)
  2. Study start3 Jul 2015
  3. Primary completion15 Dec 2019
  4. Study completion4 Sep 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This study follows a standard 3+3 patient cohort escalation design, as described below: 1. Three patients are entered at the first dose level 2. If 0/3 experiences DLT at a given dose level, then the dose is escalated to the next higher level, if a higher dose level exists, and three patients are enrolled. If a higher dose level does not exists, up to three more patients are accrued at the same dose level. 3. If 1/3 experiences DLT at current dose, then up to three more patients are accrued at the same dose level. 4. If 2 or more DLTs are observed in a three-patient or six-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to three additional patients will be enrolled at the next lower dose level, if a lower dose level exists (unless six patients have already been treated at that prior dose).
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614197
Sponsor's protocol ID
T2014-001
Status last verified
Jul 2023
First submitted
18 May 2012
Last updated
27 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Temsirolimus, Etoposide and Cyclophosphamide in people with Lymphoblastic Leukemia, Acute, Childhood and Lymphoblastic Lymphoma, run by Therapeutic Advances in Childhood Leukemia Consortium at 32 sites in 3 countries.

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 48 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Australia, Canada. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2023). 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?

Number of Patients That Experienced DLT During Cycle 1 of Therapy (time frame: Cycle 1 (a minimum of 4 weeks and a max of 8 weeks)). 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 NCT01614197.

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 27 Jul 2023.

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