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Leukaemia,LymphoblasticPhase 2NCT02660762

Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

A Phase 2 study testing Vincristine, Daunorubicin and Pegaspargase in people with Leukaemia,Lymphoblastic, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Leukaemia,Lymphoblastic
What is being tested?
Vincristine, Daunorubicin and Pegaspargase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Jan 2016to Jan 2019
Phase
Phase 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 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • newly diagnosed ALL
  • age:18-35years
  • WBC count below 30×109/L(B lineage)；WBC count below 100×109/L(T lineage)
  • absence of t(9;22), t(1;19), t(4;11) or any other 11q23 rearrangements
  • receive no chemotherapy or radiotherapy before
  • Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Who cannot join

  • mismatch the inclusion criteria
  • systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

hua wang, MD. contact

0086-02087342438

wanghua@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    yue lu, MD., 0086-02087342438, dr_luyue@sina.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults

This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia.

Read the detailed description

All patients received a modified BFM regimen which was derived from the MRCUKALLⅫ/ECOGE2993 Regimen.The differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) Pegaspargase was used instead of L- asparaginase for patient.(3)Two additional Pegaspargase treatments were added into consolidation therapy.

Being tested
Vincristine, Daunorubicin, Pegaspargase, Prednisone, Intrathecal Methotrexate
Medical subject headings
Leukemia

What participants receive

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

  • VincristineDrug

    Also called Vincasar

    induction therapy I：1.4 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 1)：1.4 mg/m2 IV d1, 8, 15, 22； Maintenance therapy: 1.4 mg/m2 intravenously every 3 months for a total of 2.5 years

  • DaunorubicinDrug

    Also called Cerubidine

    induction therapy I：60 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 3)：25 mg/m2 IV d1, 8, 15, 22；

  • PegaspargaseDrug

    Also called Oncaspar

    induction therapy I: 2500U/m2,im,d8,22 Intensification therapy:2500U/m2 im, d2,23 consolidation therapy(Cycle 2，4)：2500U/m2 im, d1

  • PrednisoneDrug

    Also called Prednisone acetate

    induction therapy I：60 mg/m2 PO d1-28; Maintenance therapy:prednisone 60 mg/m2 orally for 5 days every 3 months for a total of 2.5 years

  • Intrathecal MethotrexateDrug

    Also called Rheumatrex

    induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22

  • CyclophosphamideDrug

    Also called Cytoxan

    induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29

  • CytarabineDrug

    Also called Cytosar-U

    induction therapy II:75 mg/m2 IV d1-4, 8-11, 15-18, 22-25 consolidation therapy(Cycle 1，2，4)：75 mg/m2 intravenously on days 1 to 5 consolidation therapy(Cycle 3):75 mg/m2 intravenously on days 31 to 34 and 38 to 41

  • 6-MercaptopurineDrug

    Also called Purinethol

    induction therapy II:60 mg/m2 PO d1-28 Maintenance therapy:75 mg/m2 orally each day for a total of 2.5 years

  • MethotrexateDrug

    Also called Rheumatrex

    Intensification therapy:3 g/m2 intravenously given on days 1, 8, and 22 Maintenance therapy:20 mg/m2 orally or intravenously once a week for a total of 2.5 years.

  • EtoposideDrug

    Also called VePesid

    consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5

  • dexamethasoneDrug

    Also called Dexamethasone Sodium

    consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28

  • thioguanineDrug

    Also called 6-TG

    consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42

  • intrathecal cytarabineDrug

    Also called Cytosar-U

    50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.

Study groups in NCT02660762
Study groupRoleWhat they receive
Modified MRCUKALLⅫ/ECOGE2993 RegimenExperimentalAll patients received phase 1 of induction therapy, which consisted of daunorubicin,vincristine,Pegaspargase,prednisone and methotrexate (intrathecally).Patients went on to phase 2 at the end of phase 1.Phase 2 therapy consisted of cyclophosphamide,cytarabine,6-Mercaptopurine and methotrexate intrathecally. After Induction therapy, all patients received intensification therapy with high-dose methotrexate followed by Pegaspargase. After intensification therapy,patients received consolidation(cytarabine, etoposide,Pegaspargase,dexamethasone,vincristine,cyclophosphamide,daunorubicin,thioguanine)and maintenance therapy(vincristine,6-mercaptopurine,methotrexate ,prednisone). Intrathecal methotrexate and intrathecal cytarabine were given as CNS prophylaxis.
Receives: Drug: Vincristine; Drug: Daunorubicin; Drug: Pegaspargase; Drug: Prednisone; Drug: Intrathecal Methotrexate; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: Etoposide; Drug: dexamethasone; Drug: thioguanine; Drug: intrathecal cytarabine

What is being measured

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

  1. progression free survival

    Measured: up to end of follow-up-phase (approximately 3 years)

Secondary outcomes (4)

  1. overall survival

    Measured: up to end of follow-up-phase (approximately 3 years)

  2. complete remission rate

    Measured: every 4 weeks,up to completion of induction treatment(approximately 2months)

  3. Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

    including hematological safety and non-hematological safety.

    Measured: up to end of follow-up-phase (approximately 3 years)

  4. Minimal Residual Disease (MRD) monitoring

    Minimal residual disease is measured in bone marrow using an multiparameter flow cytometry.For the patients who achieved complete remission after induction therapy, if two consecutive tests for MRD were positive,we will define it as MRD positive

    Measured: During treatment at time point 4, 8, 12, 16,20,24, 28 weeks（every 4 weeks,up to completion of consolidation therapy）and 40，52，64，76，88，100，112，124 weeks( every 12 weeks during maintenance therapy,up to the end of treatment )

Timeline

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

  1. First posted21 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660762
Sponsor's protocol ID
SYSUCC-ALL-5010
Status last verified
Jun 2017
First submitted
13 Jan 2016
Last updated
19 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Rowe JM, Buck G, Burnett AK, Chopra R, Wiernik PH, Richards SM, Lazarus HM, Franklin IM, Litzow MR, Ciobanu N, Prentice HG, Durrant J, Tallman MS, Goldstone AH; ECOG; MRC/NCRI Adult Leukemia Working Party. Induction therapy for adults with acute lymphoblastic leukemia: results of more than 1500 patients from the international ALL trial: MRC UKALL XII/ECOG E2993. Blood. 2005 Dec 1;106(12):3760-7. doi: 10.1182/blood-2005-04-1623. Epub 2005 Aug 16.

    PubMed 16105981

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vincristine, Daunorubicin and Pegaspargase in people with Leukaemia,Lymphoblastic, run by Sun Yat-sen University at 1 site in China.

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 6 inclusion and 2 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 Jun 2017. 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 China. 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 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 hua wang, MD. (0086-02087342438, wanghua@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: up to end of follow-up-phase (approximately 3 years)). 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 NCT02660762, which also lists 1 linked publication.

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 Jun 2017.

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