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Chronic Lymphocytic LeukemiaPhase 2NCT04059081

A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment

A Phase 2 study testing Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by Deok-Hwan Yang at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteSouth Korea
Study dates
9 Jul 2019to 8 Jul 2022
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
  • Newly diagnosed chronic lymphocytic leukemia
  • Age≥ 70 years
  • Satisfy the one of indications for starting treatment guideline
  • <!-- -->
  • Evidence of progressive marrow failure (anemia, thrombocytopenia)
Show all 12Show fewer
  • AIHA, thrombocytopenia refractory to steroids
  • Massive (>6cm, LCM) or symptomatic splenomegaly
  • Massive nodes (>10 cm) or symptomatic
  • Progressive lymphocytosis
  • 50% increase over 2 months or LDT < 6 months
  • Constitutional Symptoms : weight loss > 10% in 6 months, significant fatigue, fever >38 over 2 weeks, night sweat > 1month 4. ECOG performance status 0-2 5. Total bilirubin ≤ 1.5 x ULN (upper limit of normal) 6. Aspartate aminotransferase (AST) ≤ 5 x ULN, (ALT) ≤ 5 x ULN 7. Creatinine ≤ 3.0 x ULN 8. Provide informed consent Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Who cannot join

  • Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
  • Hairy cell leukemia or prolymphocytic leukemia
  • Uncontrolled infection
  • Therapy history with combined chemotherapy or biologic therapy prior to registration
  • History of thromboembolic episodes ≤ 3 months prior to registration
  • Active hepatitis B or C with uncontrolled disease
Show all 9Show fewer
  • Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
  • Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
  • Concurrent participation in another therapeutic clinical trial.

Trial locations and contacts

1 site in 1 country.

Deok-Hwan Yang, M.D., Ph.D. contact

drydh1685@hotmail.com

Young-il Koh, M.D., Ph.D. contact

snuhgo01@gmail.net

South Korea1 site, 1 recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 519-809

    So-Young Lee, Nurse, 82-61-379-7628, kaosin@naver.com

    Deok-Hwan Yang, M.D.,Ph.D.

    Recruiting

Other trials in South Korea

About this study

This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.

Being tested
Obinutuzumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • ObinutuzumabDrug

    Obinutuzumab is provided as single-use vials for intravenous administration only. Obinutuzumab 1000mg fixed dose will be administered Chlorambucil would be provided as oral tablet with dose of 0.5mg/kg

    Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, until 6 cycles.

Study groups in NCT04059081
Study groupRoleWhat they receive
GC chemotherapyExperimentalBefore administration of GC chemotherapy, all patients must undergo pretreatment bone marrow biopsy. The pretreatment BM biopsy must include at least 1 long core biopsy samples and 10 cc of aspirate. Obinutuzumab 1000mg fixed dose will be administered intravenously (Day 1,8,15 for cycle 1 and D1 for subsequent cycles). Chlorambucil 0.5mg/kg will be administered orally (D1,15 for all cycles). 28 days are considered as one cycle, and cycles will be repeated every 4-weeks for a total of 6 cycles.
Receives: Drug: Obinutuzumab

What is being measured

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

  1. Overall response rate

    iwCLL criteria

    Measured: 3 years

Secondary outcomes (3)

  1. Complete remission rate

    No evidence of disease at the time of tumor assessment by NGS method

    Measured: 3 years

  2. Progression free survival

    the time from first dose to documented disease progression

    Measured: 3 years

  3. Overall survival

    the time from first dose to death from any cause

    Measured: 3 years

Timeline

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

  1. First posted16 Aug 2019
  2. Study start9 Jul 2019
  3. Primary completion8 Jul 2022 (estimated)
  4. Study completion8 Jul 2022 (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
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04059081
Sponsor's protocol ID
ML40990
Status last verified
Aug 2019
First submitted
15 Aug 2019
Last updated
16 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating M, Montserrat E, Chiorazzi N, Stilgenbauer S, Rai KR, Byrd JC, Eichhorst B, O'Brien S, Robak T, Seymour JF, Kipps TJ. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018 Jun 21;131(25):2745-2760. doi: 10.1182/blood-2017-09-806398. Epub 2018 Mar 14.

    PubMed 29540348

  • Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.

    PubMed 24401022

  • Fabbri G, Dalla-Favera R. The molecular pathogenesis of chronic lymphocytic leukaemia. Nat Rev Cancer. 2016 Mar;16(3):145-62. doi: 10.1038/nrc.2016.8.

    PubMed 26911189

  • Herling CD, Klaumunzer M, Rocha CK, Altmuller J, Thiele H, Bahlo J, Kluth S, Crispatzu G, Herling M, Schiller J, Engelke A, Tausch E, Dohner H, Fischer K, Goede V, Nurnberg P, Reinhardt HC, Stilgenbauer S, Hallek M, Kreuzer KA. Complex karyotypes and KRAS and POT1 mutations impact outcome in CLL after chlorambucil-based chemotherapy or chemoimmunotherapy. Blood. 2016 Jul 21;128(3):395-404. doi: 10.1182/blood-2016-01-691550. Epub 2016 May 25.

    PubMed 27226433

  • Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, Bartlett NL, Brander DM, Barr PM, Rogers KA, Parikh SA, Coutre S, Hurria A, Brown JR, Lozanski G, Blachly JS, Ozer HG, Major-Elechi B, Fruth B, Nattam S, Larson RA, Erba H, Litzow M, Owen C, Kuzma C, Abramson JS, Little RF, Smith SE, Stone RM, Mandrekar SJ, Byrd JC. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018 Dec 27;379(26):2517-2528. doi: 10.1056/NEJMoa1812836. Epub 2018 Dec 1.

    PubMed 30501481

  • Kim JA, Hwang B, Park SN, Huh S, Im K, Choi S, Chung HY, Huh J, Seo EJ, Lee JH, Bang D, Lee DS. Genomic Profile of Chronic Lymphocytic Leukemia in Korea Identified by Targeted Sequencing. PLoS One. 2016 Dec 13;11(12):e0167641. doi: 10.1371/journal.pone.0167641. eCollection 2016.

    PubMed 27959900

  • Maury S, Chevret S, Thomas X, Heim D, Leguay T, Huguet F, Chevallier P, Hunault M, Boissel N, Escoffre-Barbe M, Hess U, Vey N, Pignon JM, Braun T, Marolleau JP, Cahn JY, Chalandon Y, Lheritier V, Beldjord K, Bene MC, Ifrah N, Dombret H; for GRAALL. Rituximab in B-Lineage Adult Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Sep 15;375(11):1044-53. doi: 10.1056/NEJMoa1605085.

    PubMed 27626518

  • Thomas DA, O'Brien S, Faderl S, Garcia-Manero G, Ferrajoli A, Wierda W, Ravandi F, Verstovsek S, Jorgensen JL, Bueso-Ramos C, Andreeff M, Pierce S, Garris R, Keating MJ, Cortes J, Kantarjian HM. Chemoimmunotherapy with a modified hyper-CVAD and rituximab regimen improves outcome in de novo Philadelphia chromosome-negative precursor B-lineage acute lymphoblastic leukemia. J Clin Oncol. 2010 Aug 20;28(24):3880-9. doi: 10.1200/JCO.2009.26.9456. Epub 2010 Jul 26.

    PubMed 20660823

  • Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhofer N, Rohrberg R, Soling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Dohner H, Emmerich B, Hallek M; German CLL Study Group (GCLLSG). First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009 Oct 15;114(16):3382-91. doi: 10.1182/blood-2009-02-206185. Epub 2009 Jul 15.

    PubMed 19605849

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab in people with Chronic Lymphocytic Leukemia, run by Deok-Hwan Yang at 1 site in South Korea.

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 12 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 South Korea. 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 Deok-Hwan Yang, M.D., Ph.D. (drydh1685@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 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 NCT04059081, 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 16 Aug 2019.

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