Relapsed T-Cell Acute Lymphoblastic LeukemiaPhase 1/2NCT00981799
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
A Phase 1/2 study testing Nelarabine, Etoposide and Cyclophosphamide in people with Relapsed T-Cell Acute Lymphoblastic Leukemia and Relapsed T-Cell Lymphoblastic Lymphoma, run by Therapeutic Advances in Childhood Leukemia Consortium at 37 sites in 7 countries.
Trial summary
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Relapsed T-Cell Acute Lymphoblastic Leukemia, Relapsed T-Cell Lymphoblastic Lymphoma
- What is being tested?
- Nelarabine, Etoposide and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 37 sitesin 7 countries
- Study dates
- Jun 2010to 18 Jul 2016
- Phase
- Phase 1/2
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients to be enrolled in the dose-escalation portion of this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL or T-LL). Patients to be enrolled in the cohort expansion portion of this study (ie, those treated at the recommended phase 2 dose) must have T-cell ALL in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL). T-LL patients are not eligible for the cohort expansion phase.
- Patients with T-cell ALL must have greater than 25% blasts in the bone marrow with or without extramedullary disease.
- Patients with T-cell LL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis. Patients with T-cell LL enrolled in the phase I dose-escalation study are not required to have measurable disease; however, patients enrolled in the phase II cohort expansion at the MTD must have measurable disease.
- Patients may have CNS 1 or CNS 2 disease but not CNS 3.
- ECOG 0-2 or Karnofsky ≥ 50% for patients > 16 years of age; Lansky ≥ 50% for patients ≤16 years of age.
- Patients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they MAY NOT BEGIN TREATMENT ON THIS PROTOCOL UNTIL A MINIMUM OF 7 DAYS HAS ELAPSED SINCE PRIOR INTRATHECAL THERAPY.
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- At least 6 weeks must have elapsed since administration of nitrosureas.
- At least 12 weeks must have elapsed since administration of craniospinal or hemipelvic radiation.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks 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 and for a minimum of 6 months after study treatment.
- Adequate renal function defined as serum creatinine ≤ 1.5x upper limit of normal (ULN) for age. If the serum creatinine is above these values, the calculated creatinine clearance or radioisotope GFR must be ≥ 70 mL/min/1.73m2.
- Total bilirubin ≤ 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ≤ ULN for age.
- ALT ≤ 5x ULN of normal for age.
- Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or ejection fraction ≥ 45% by gated radionuclide study.
- No evidence of dyspnea at rest
- No exercise intolerance
- A pulse oximetry ≥ 94% at sea level (≥ 90% at altitude ≥ 5000 feet) if there is clinical indication for determination.
- Patients and/or their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients and/or their parents or legal guardians must sign a written informed consent.
Who cannot join
- Patients with Down syndrome are excluded.
- Patients with pre-existing Grade 2 (or greater) peripheral motor or sensory neurotoxicity per the CTCAE 3.0 as determined by the treating physician or a neurologist.
- Patients with a history of prior veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin >1.4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.
- Previous hematopoetic stem cell transplantation.
- Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine. For the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years.
- Positive blood culture within 48 hours of study enrollment.
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- Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection.
- Plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
- Any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States26 sites
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109-0914
Children's Healthcare of Atlanta, Emory University
Atlanta, Georgia
The Children's Hospital, University of Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland
Dana Farber
Boston, Massachusetts
Levine Children's Hospital at Carolinas Medical Center
Charlotte, North Carolina, 28203
Lurie Children's Hospital
Chicago, Illinois
Rainbow Babies
Cleveland, Ohio
Nationwide Childrens Hospital
Columbus, Ohio
University of Texas at Southwestern
Dallas, Texas
Cook Children's Hospital
Fort Worth, Texas
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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
Vanderbilt Children's Hospital
Nashville, Tennessee
New York University Medical Center
New York, New York, 10016
Children's Hospital New York-Presbyterian
New York, New York, 10032
Children's Hospital Orange County
Orange, California
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
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
Canada3 sites
Sainte Justine University Hospital
Montreal, Quebec
Hospital for Sick Kids
Toronto, Ontario
British Columbia Children's Hospital
Vancouver
About this study
Official title: A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
- Being tested
- Nelarabine, Etoposide, Cyclophosphamide, Methotrexate, Filgrastim
- Keywords
- Relapse, T cell, Lymphoblastic, Leukemia, Lymphoma, Nelarabine, TACL, NECTAR
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelarabineDrug
Also called Arranon, Compound 506U78
Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5.
EtoposideDrug
Also called VePesid, Etopophos, VP-16
100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5
CyclophosphamideDrug
Also called Cytoxan
Dose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5.
MethotrexateDrug
Also called MTX, Amethopterin, Trexall
Give between day 29 and 36 or when ANC>750 and PLTS>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation.
Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but <2 years of age 10 mg for patients age greater than or equal to 2, but <3 years of age 12 mg for patients greater than or equal to 3, but < 9 years of age 15 mg for patients greater than or equal to >9 years of age
FilgrastimDrug
Also called Neupogen, GCSF, granulocyte colony stimulating factor
5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000/mm3 for two consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Nelarabine Dose Level 1 | Experimental | The study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded. The first 3 patients will be enrolled into Dose Level 1. If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed. Receives: Drug: Nelarabine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Filgrastim |
| Nelarabine Dose Level 2 | Experimental | Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide. Receives: Drug: Nelarabine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Filgrastim |
| Nelarabine Dose Level 3 | Experimental | Patients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide Receives: Drug: Nelarabine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Filgrastim |
| Nelarabine Dose Level 0 | Experimental | Patients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed. Receives: Drug: Nelarabine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Methotrexate; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL.
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed.
Measured: 6 months
Secondary outcomes (1)
To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL.
Patients will be evaluated at each dose level and for assessment of response to treatment. Not all patients enrolled at each dose level has been assessed to be evaluable for response. Only those that have met criteria for being evaluable for response will be counted in the Overall Number of Participants Analyzed.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJun 2010
- Primary completionNov 2015
- Study completion18 Jul 2016
Why it stopped: Slow accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed T-Cell Acute Lymphoblastic LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Novartis
- Responsible party
- Sponsor
- Investigators
- Jim Whitlock, MD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981799
- Sponsor's protocol ID
- T2008-002
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2009
- Last updated
- 1 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL and POETIC
- ClinicalTrials.gov ID
- NCT00981799
- Acronym / sponsor ID
- T2008-002
- Keywords
- Relapse, T cell, Lymphoblastic, Leukemia, Lymphoma, Nelarabine, TACL, NECTAR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual rate
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia ConsortiumUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Novartis
- Study start
- Jun 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- 18 Jul 2016 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 1 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nelarabine Dose Level 1 | Experimental | Drug: Nelarabine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Methotrexate, Drug: FilgrastimThe study will begin at Dose Level 1 at 480 mg/m2 Nelarabine (75% of single agent maximum tolerated dose) and 330 mg/m2 Cyclophospamide and will escalate to the next Dose Level if the maximum tolerated dose (MTD) is not exceeded. The first 3 patients will be enrolled into Dose Level 1. If 0/3 experiences dose limiting toxicity (DLT) at a given dose level, then the dose is escalated to the next higher level and 3 more patients are enrolled. If 1/3 experiences DLT at current dose, the up to 3 more patients are accrued at the same dose level. If 2 or more DLTs are observed in a 3-patient or 6-patient cohort at a given dose level, then the MTD has been exceeded, dose escalation will be stopped, and up to 3 additional patients will be enrolled at the next lower dose level (unless 6 patients have already been treated at that prior dose). If the MTD is exceeded at Dose Level 0, the study will be closed. |
| Nelarabine Dose Level 2 | Experimental | Drug: Nelarabine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Methotrexate, Drug: FilgrastimPatients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 330 mg/m2 Cyclophosphamide. |
| Nelarabine Dose Level 3 | Experimental | Drug: Nelarabine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Methotrexate, Drug: FilgrastimPatients in this arm will be administered Nelarabine at 650 mg/m2 (100% of single agent MTD) and 400 mg/m2 Cyclophosphamide |
| Nelarabine Dose Level 0 | Experimental | Drug: Nelarabine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Methotrexate, Drug: FilgrastimPatients in this arm will be administered Nelarabine 325 mg/m2 (50% of single agent MTD) and 330 mg/2 Cyclophosphamide. Patients will only enter this arm if the MTD at Dose Level 1 has been exceeded. If the MTD is exceeded at Dose Level 0, the study will be closed. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Patients to be enrolled in the dose-escalation portion of this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL or T-LL). Patients to be enrolled in the cohort expansion portion of this study (ie, those treated at the recommended phase 2 dose) must have T-cell ALL in first relapse or must have failed primary induction chemotherapy (ie, never attained a complete remission following an initial course of standard therapy for T-ALL). T-LL patients are not eligible for the cohort expansion phase.
- Patients with T-cell ALL must have greater than 25% blasts in the bone marrow with or without extramedullary disease.
- Patients with T-cell LL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis. Patients with T-cell LL enrolled in the phase I dose-escalation study are not required to have measurable disease; however, patients enrolled in the phase II cohort expansion at the MTD must have measurable disease.
- Patients may have CNS 1 or CNS 2 disease but not CNS 3.
- ECOG 0-2 or Karnofsky ≥ 50% for patients > 16 years of age; Lansky ≥ 50% for patients ≤16 years of age.
Key exclusion criteria (9 listed)
- Patients with Down syndrome are excluded.
- Patients with pre-existing Grade 2 (or greater) peripheral motor or sensory neurotoxicity per the CTCAE 3.0 as determined by the treating physician or a neurologist.
- Patients with a history of prior veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin >1.4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.
- Previous hematopoetic stem cell transplantation.
- Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine. For the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years.
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 |
|---|---|---|
| NelarabineAlso: Arranon, Compound 506U78Dose will be assigned at study entry. Nelarabine will be given IV over 60 minutes (given at hours 0 to 1) on days 1 through 5. | Drug | Nelarabine Dose Level 0, Nelarabine Dose Level 1, Nelarabine Dose Level 2, Nelarabine Dose Level 3 |
| EtoposideAlso: VePesid, Etopophos, VP-16100 mg/m2/day IV over 2 hours (given at hours 1 to 3) on days 1 through 5 | Drug | Nelarabine Dose Level 0, Nelarabine Dose Level 1, Nelarabine Dose Level 2, Nelarabine Dose Level 3 |
| CyclophosphamideAlso: CytoxanDose will be assigned at study entry, IV as a 30-60 minute infusion (given at hours 3 to 4) on days 1 through 5. | Drug | Nelarabine Dose Level 0, Nelarabine Dose Level 1, Nelarabine Dose Level 2, Nelarabine Dose Level 3 |
| MethotrexateAlso: MTX, Amethopterin, TrexallGive between day 29 and 36 or when ANC>750 and PLTS>75,000 - whichever comes first (but not prior to day 22) at the dose defined by age below, ideally in conjunction with BM evaluation. Given intrathecally at the dose defined by age below. 8 mg for patients age greater than or equal to 1, but <2 years of age 10 mg for patients age greater than or equal to 2, but <3 years of age 12 mg for patients greater than or equal to 3, but < 9 years of age 15 mg for patients greater than or equal to >9 years of age | Drug | Nelarabine Dose Level 0, Nelarabine Dose Level 1, Nelarabine Dose Level 2, Nelarabine Dose Level 3 |
| FilgrastimAlso: Neupogen, GCSF, granulocyte colony stimulating factor5 micrograms/kg/day IV or SC will begin on Day 6 and end when the ANC is > 1000/mm3 for two consecutive days. | Drug | Nelarabine Dose Level 0, Nelarabine Dose Level 1, Nelarabine Dose Level 2, Nelarabine Dose Level 3 |
Primary outcome
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL.
Time frame: 6 months
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed.
1 secondary outcome
To Determine the Complete Remission Rate After 1 and 2 Courses of This Therapy in Children With T-ALL and Bone Marrow Relapse or T-LL.
Time frame: 1-3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For more information about this and other clinical trials, please visit the TACL websiteLink provided by the sponsor.
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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.
Jim Whitlock, MD study chair
The Hospital for Sick Children
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nelarabine, Etoposide and Cyclophosphamide in people with Relapsed T-Cell Acute Lymphoblastic Leukemia and Relapsed T-Cell Lymphoblastic Lymphoma, run by Therapeutic Advances in Childhood Leukemia Consortium at 37 sites in 7 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 19 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Australia, Canada, Austria, France and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2020). 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?
To Determine the Presence of Dose-limiting Toxicities (DLTs) of Nelarabine, Etoposide and Cyclophosphamide When Given in Combination to Children With T-ALL and Bone Marrow Relapse or T-LL. (time frame: 6 months). 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 1 Oct 2020.