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CD20 Positive Diffuse Large B-cell LymphomaPhase 2FIL_GAELNCT02495454

GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma

A Phase 2 study testing Ga101 in people with CD20 Positive Diffuse Large B-cell Lymphoma and Elderly Unfit Patients, run by Fondazione Italiana Linfomi - ETS at 16 sites in Italy.

Terminated

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

Official record
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Trial summary

GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Ga101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
16 sitesItaly
Study dates
25 Aug 2015to 22 Mar 2017
Phase
Phase 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade III B lymphoma, according to WHO (World Health Organization) classification (local pathologist)
  • Age ≥ 65 years
  • No previous treatment
  • CGA assessment (Comprehensive Geriatric Assessment) performed before starting treatment
  • Unfit patients defined as follows:
  • Age > 80 years with Fit profile, i.e. ADL (Activity of Daily Living) =6 residual functions IADL (Instrumental Activity of Daily Living) =8 residual functions CIRS (Cumulative Illness Rating Scale): no comorbidity of grade 3-4 and <5 of grade 2 or Age < 80 with Unfit profile, i.e ADL(Activity of Daily Living) > 5 residual functions IADL (Instrumental Activity of Daily Living) > 6 residual functions CIRS (Cumulative Illness Rating Scale): no comorbidity of grade 3-4 and 5-8 co-morbidities of grade 2
Show all 16Show fewer
  • Ann Arbor Stage I with bulky, II-IV
  • At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
  • Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:
  • Hemoglobin ≥ 10 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L
  • LVEF (Left Ventricular Ejection Fraction) >50%
  • Ability and willingness to comply with the study protocol procedure
  • Life expectancy > 6 months
  • Accessibility of patient for treatment and follow up
  • Written informed consent

Who cannot join

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Contraindication to any of the individual components of CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), including prior receipt of anthracyclines
  • History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • Stage I without bulky
  • Patients with transformed lymphoma
  • Prior therapy for DLBCL (Diffuse Large B Cell Lymphoma), with the exception of nodal biopsy or local irradiation
Show all 12Show fewer
  • Previous exposure to cytotoxic agents
  • Suspect or clinical evidence of CNS (Central Nervous System) involvement by lymphoma
  • HBsAg (Hepatitis B surface antigen), HCV (Hepatitis C Virus) or HIV (Human Immunodeficiency Virus) positivity; isolated HBcAb (Hepatitis B surface antibody) positivity is accepted only with concomitant treatment with Lamivudine
  • AST /ALT (Aspartate Aminotransferase/Alanine Aminotransferase)> twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl (unless these abnormalities were related to the lymphoma)
  • Evidence of any severe active acute or chronic infection
  • Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • A.O. SS. Antonio e Biagio e C. Arrigo

    Alessandria, 15121

  • A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

    Ancona, 60126

  • A.O. Ospedale Degli Infermi

    Biella, 13900

  • A.O. Spedali Civili

    Brescia, BS, 25100

  • Area Vasta Romagna e IRST

    Meldola (FC)

  • IRCCS, Istituto Nazionale dei Tumori

    Milan

  • A.O. Universitaria Policlinico Di Modena

    Modena, 41124

  • SCDU Ematologia - Università del Piemonte Orientale

    Novara, 28100

  • Irccs Istituto Oncologico Veneto (Iov)

    Padova, 35128

  • Oncoematologia e TMO Dopartimento Oncologia La Maddalena

    Palermo

  • AUSL di Ravenna

    Ravenna, RA, 48100

  • Asmn-Irccs

    Reggio Emilia, RE, 43123

  • Ausl Di Rimini

    Rimini, 47924

  • A.O. S. Maria di Terni

    Terni, TR, 05100

  • Ematologia 1U - AO Città della Salute e della Scienza

    Torino, TO, 10126

  • Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

    Varese, 21100

Other trials in Italy

About this study

Official title: GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma A Phase II Study of the Fondazione Italiana Linfomi (FIL)

GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.

Read the detailed description

Considering that the treatment of elderly unfit patients with DLBCL cannot be based on a full course of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), and that using a less intense R-miniCHOP (an attenuated version of the standard R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) combination an acceptable cure rate can be achieved this study is designed to try to improve the cure rate in unfit patients with DLBCL (Diffuse Large B Cell Lymphoma) by adopting the R-miniCHOP scheme substituting Rituximab with the more active GA101 monoclonal antibody. The study hypothesis is that a higher activity of the treatment can be achieved without modifying the cytotoxic part of the treatment but using a more active immunotherapy. Differently from the previous experience with R-miniCHOP eligible patient are not only identified using anagraphic criteria but adopting CGA (Comprehensive Geriatric Assessment) as part of initial assessment and considering as eligible unfit patients.

Being tested
Ga101

What participants receive

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

  • Ga101Drug

    Also called Obinutuzumab

Study groups in NCT02495454
Study groupRoleWhat they receive
Ga101-miniCHOPExperimental6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101). GA101-miniCHOP regimen: * Cycle 1 GA101: 1000 mg day 1, day 8 and day 15, iv Cyclophosphamide: 400 mg/mq, day 1, iv Doxorubicin: 25 mg/mq, day 1, iv Vincristine: 1 mg, day 1, iv Prednisone: 40 mg/mq, days 1-5, os * Cycles 2-6 GA101: 1000 mg day 1, iv Cyclophosphamide: 400 mg/mq, day 1, iv Doxorubicin: 25 mg/mq, day 1, iv Vincristine: 1 mg, day 1, iv Prednisone: 40 mg/mq, days 1-5, os * Two additional infusions of GA101: 1000 mg day 1, iv, every 21 days.
Receives: Drug: Ga101

What is being measured

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

  1. Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images.

    Complete Response Rate after 10 infusions of GA101 and 6 cycles of miniCHOP. Complete Remission (CR): Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, normalization of biochemistry abnormalities. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site. Partial disease (PR): >= 50% decrease in node diameter of the six largest dominant nodes or nodal masses and no new sites of disease; Stable disease (SD): is defined as less than a PR but is not progressive disease. Progession disease (PD): >50% increase diameter of node from nadir of any previously identified abnormal node nonresponders, and/or appearance of any new lesion.

    Measured: Up to 36 months.

Secondary outcomes (9)

  1. Adverse Events (AEs)

    Rate of Adverse Events. Although was not defined a formal threshold, in this section we reported the summary of frequencies of maximum CTCAE observed in patients. Each patient was counted only once within the AE terms during the therapy. If, during the therapy the patient experiences more than one AE, only the AE with the greatest intensity was included in the summary.

    Measured: Up to 36 months

  2. Partial Response Rate (PRR)

    Partial Response Rate (PRR): patients in Partial Response after induction therapy.

    Frequency of PRR already reported in the table of principal end-point.

    Measured: Up to 36 months

  3. ORR (Overall Response Rate)

    ORR (Overall Response Rate): sum of patiens with Complete or Partial response after the induction therapy.

    Measured: Up to 36 months

  4. OS (Overall Survival)

    OS (Overall Survival): defined as the time from the date of treatment start into the study until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study, and patients who are lost to follow up, will be censored at the date of the last contact.

    Measured: Up to 36 months

  5. PFS (Progression Free Survival)

    PFS (Progression Free Survival): defined as the time from entry into the study until lymphoma relapse/ progression or death as a result of any cause. Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date.

    Measured: Up to 36 months

  6. Activities of Daily Living (ADL)

    Change in Activities of daily living score. The score ranging from 0 (bad performance) to 6 (good performance)

    Measured: Up to 36 months

  7. Instrumental Activities of Daily Living (IADL)

    Change in Instrumental Activities of Daily Living score. The score ranging from 0 (bad performance) to 8 (good performance).

    Measured: Up to 36 months

  8. Cumulative Illness Rating Scale (CIRS)

    Change in Cumulative Illness Rating Scale. The grading of comorbidity ranging from 0 (absent) to 4 (severe).

    Measured: Up to 36 months

  9. Questionnaire for Quality of Life (EORTC QLQ C30)

    Change in quality of life (QoL)

    Measured: Up to 36 months

Timeline

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

  1. First posted13 Jul 2015 (estimated)
  2. Study start25 Aug 2015
  3. Primary completion22 Mar 2017
  4. Study completion22 Mar 2017

Why it stopped: Primary objective not obtained after interim analysis

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495454
Sponsor's protocol ID
FIL_GAEL
Other IDs
2014-005697-10, 2014
Acronym
FIL_GAEL
Status last verified
Aug 2020
First submitted
8 Jun 2015
Last updated
5 Nov 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ga101 in people with CD20 Positive Diffuse Large B-cell Lymphoma and Elderly Unfit Patients, run by Fondazione Italiana Linfomi - ETS at 16 sites in Italy.

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 16 inclusion and 12 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 5 Nov 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?

Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. (time frame: Up to 36 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 NCT02495454.

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 5 Nov 2020.

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