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Chronic Myeloid Leukemia - Chronic PhasePhase 3DANINNCT03079505

Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia

A Phase 3 study testing Dasatinib 100 MG [Sprycel] and Nilotinib 150mg oral capsule [Tasigna] in people with Chronic Myeloid Leukemia - Chronic Phase, run by Hamad Medical Corporation at 1 site in Qatar.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia - Chronic Phase
What is being tested?
Dasatinib 100 MG [Sprycel] and Nilotinib 150mg oral capsule [Tasigna]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteQatar
Study dates
3 Aug 2017to 23 Sep 2018
Phase
Phase 3
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

  • Male or female patients 18 years or over.
  • Patients must have all of the following:
  • be enrolled within 3 months of initial diagnosis of CML-CP (Chronic Phase) (date of initial diagnosis is the date of first cytogenetic analysis)
  • cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations
  • patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome.
  • < 15% blasts in peripheral blood and bone marrow;
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  • < 30% blasts plus promyelocytes in peripheral blood and bone marrow;
  • < 20% basophils in peripheral blood,
  • 100 x 109/L platelets or greater
  • no evidence of extramedullary leukaemic involvement, with the exception of the hepatosplenomegaly.
  • Written voluntary informed consent.

Who cannot join

  • 1 - Patients with Ph-negative, BCR-ABL-positive, disease are NOT eligible for the study.
  • 2. Any prior treatment for CML with: any tyrosine kinase inhibitor (eg imatinib, dasatinib); busulphan; interferon-alpha; homoharringtonine; cytosine arabinoside; any other investigational agents (hydroxycarbamide and anagrelide are the only drugs permitted). Patients will be ineligible for the study if they have received any prior therapy with interferon-alpha or imatinib. No exceptions.
  • 3. Patients who received prior chemotherapy, including regimens used in peripheral blood progenitor cells (PBPCs) mobilisation for haematopoietic progenitor-cell transplantation. (It is allowable to collect unmobilised PBPCs at diagnosis.) 4. Patient who have had any form of prior haemopoietic stem cell transplant, either autograft or allograft.
  • 5. Patients with an ECOG (Eastern Cooperative Oncology Group) Performance Status Score of 2 or less.
  • 6. Patients with serum bilirubin, AST (aspartate aminotransferase), ALT (alanine aminotransferase), or creatinine concentrations > 2.0 x the institutional upper limit of the normal range (IULN).
  • 7. Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulants.
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  • 8. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, infection, angina, or Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
  • 9. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
  • 10. Patients who have undergone major surgery within 4 weeks of Study Day 1, or who have not recovered from prior major surgery.
  • 11. Patients who are:
  • pregnant,
  • breast feeding,
  • of childbearing potential without a negative pregnancy test prior to Study Day 1, and
  • male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • 12. Patients with a history of another malignancy either currently or within the past five years, with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
  • 13. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable

Trial locations and contacts

1 site in 1 country.

Qatar1 site

  • National Center for Cancer Care & Research (NCCCR)

    Doha, 3050

Other trials in Qatar

About this study

Official title: Dasatinib Versus Nilotinib as Upfront Therapy for Treatment Naïve Chronic Myeloid Leukemia Chronic Phase

DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net recommendations the study will be conducted in NCCCR (National Center for Cancer Care \& Research) sample size calculations detailed in the statistic part the clinical hematologist will recruit the patients this will include consenting process inclusion and exclusion criteria the molecular pathologist will do the molecular testing the clinical research coordinator and fellows will do the CRF (Case Report Form) as well as quality of life questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid Leukemia).

Being tested
Dasatinib 100 MG [Sprycel], Nilotinib 150mg oral capsule [Tasigna]
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • Dasatinib 100 MG [Sprycel]Drug

    Also called Sprycel

    Dasatinib (Sprycel) 100 milligram, once-daily (QD) will be given to 25 patients orally

  • Nilotinib 150mg oral capsule [Tasigna]Drug

    Also called Tasigna

    Nilotinib (Tasigna) 300 milligram, twice-daily (BID) will be given to 25 patients orally

Study groups in NCT03079505
Study groupRoleWhat they receive
DasatinibActive comparatorDasatinib 100mg, once daily (QD), will be given to 25 patients, orally
Receives: Drug: Nilotinib 150mg oral capsule [Tasigna]
NilotinibExperimentalNilotinib 300mg, twice daily (BID), will be given to 25 patients, orally
Receives: Drug: Dasatinib 100 MG [Sprycel]

What is being measured

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

  1. Number of patients with a Molecular Response Rate (MMR) at 12 Months from the baseline

    Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)

    Measured: 12 Months

Secondary outcomes (3)

  1. Number of patients with a Durable Molecular Response Rate (MMR) from the baseline

    Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene) Number of patients with a maintained MMR for 5 years

    Measured: 12 months to 5 years

  2. Number of patients with a Reduction in BCR-ABL Transcript Levels in both arms from the baseline

    BCR-ABL ≤ 10% at 3 months BCR-ABL < 1% at 6 months BCR-ABL ≤ 0.1% at 12 months

    then MMR or better

    BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)

    Measured: 5 years

  3. Number of patients with a Complete Cytogenetic Response (CCyR) in both arms from the baseline

    Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR (Complete Cytogenetic Response).

    Measured: 5 years

Timeline

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

  1. First posted14 Mar 2017
  2. Study start3 Aug 2017
  3. Primary completion23 Sep 2018
  4. Study completion23 Sep 2018

Why it stopped: Protocol Deviation

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079505
Sponsor's protocol ID
17095/17
Acronym
DANIN
Status last verified
Nov 2018
First submitted
8 Mar 2017
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Goldman JM, Melo JV. Targeting the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med. 2001 Apr 5;344(14):1084-6. doi: 10.1056/NEJM200104053441409. No abstract available.

    PubMed 11287980

  • Hehlmann R, Saussele S. Treatment of chronic myeloid leukemia in blast crisis. Haematologica. 2008 Dec;93(12):1765-9. doi: 10.3324/haematol.2008.001214. No abstract available.

    PubMed 19050065

  • Druker BJ, Guilhot F, O'Brien SG, Gathmann I, Kantarjian H, Gattermann N, Deininger MW, Silver RT, Goldman JM, Stone RM, Cervantes F, Hochhaus A, Powell BL, Gabrilove JL, Rousselot P, Reiffers J, Cornelissen JJ, Hughes T, Agis H, Fischer T, Verhoef G, Shepherd J, Saglio G, Gratwohl A, Nielsen JL, Radich JP, Simonsson B, Taylor K, Baccarani M, So C, Letvak L, Larson RA; IRIS Investigators. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006 Dec 7;355(23):2408-17. doi: 10.1056/NEJMoa062867.

    PubMed 17151364

  • Deininger M, O'Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with imatinib [abstract]. Blood (ASH Annual Meeting Abstracts) 2009;114(22). Abstract 1126.

  • de Lavallade H, Apperley JF, Khorashad JS, Milojkovic D, Reid AG, Bua M, Szydlo R, Olavarria E, Kaeda J, Goldman JM, Marin D. Imatinib for newly diagnosed patients with chronic myeloid leukemia: incidence of sustained responses in an intention-to-treat analysis. J Clin Oncol. 2008 Jul 10;26(20):3358-63. doi: 10.1200/JCO.2007.15.8154. Epub 2008 Jun 2.

    PubMed 18519952

  • O'Hare T, Walters DK, Stoffregen EP, Jia T, Manley PW, Mestan J, Cowan-Jacob SW, Lee FY, Heinrich MC, Deininger MW, Druker BJ. In vitro activity of Bcr-Abl inhibitors AMN107 and BMS-354825 against clinically relevant imatinib-resistant Abl kinase domain mutants. Cancer Res. 2005 Jun 1;65(11):4500-5. doi: 10.1158/0008-5472.CAN-05-0259.

    PubMed 15930265

  • Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1.

    PubMed 24180494

  • Cortes JE, Jones D, O'Brien S, Jabbour E, Ravandi F, Koller C, Borthakur G, Walker B, Zhao W, Shan J, Kantarjian H. Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia. J Clin Oncol. 2010 Jan 20;28(3):398-404. doi: 10.1200/JCO.2009.25.4920. Epub 2009 Dec 14.

    PubMed 20008620

  • Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

    PubMed 20525995

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasatinib 100 MG [Sprycel] and Nilotinib 150mg oral capsule [Tasigna] in people with Chronic Myeloid Leukemia - Chronic Phase, run by Hamad Medical Corporation at 1 site in Qatar.

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 11 inclusion and 16 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 23 Jan 2019. 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 Qatar. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Protocol Deviation). Results are not available in the source record.

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 with a Molecular Response Rate (MMR) at 12 Months from the baseline (time frame: 12 Months). 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 NCT03079505, which also lists 9 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 23 Jan 2019.

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