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

NCT ID: NCT02495454

Last Updated: 2020-11-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-25

Study Completion Date

2017-03-22

Brief Summary

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

Detailed Description

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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.

Conditions

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CD20 Positive Diffuse Large B-cell Lymphoma Elderly Unfit Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ga101-miniCHOP

6 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.

Group Type EXPERIMENTAL

Ga101

Intervention Type DRUG

Interventions

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Ga101

Intervention Type DRUG

Other Intervention Names

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Obinutuzumab

Eligibility Criteria

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Inclusion Criteria

1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade III B lymphoma, according to WHO (World Health Organization) classification (local pathologist)
2. Age ≥ 65 years
3. No previous treatment
4. CGA assessment (Comprehensive Geriatric Assessment) performed before starting treatment
5. 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
6. Ann Arbor Stage I with bulky, II-IV
7. At least one bi-dimensionally measurable lesion defined as \> 1.5 cm in its largest dimension on CT scan
8. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
9. 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
10. LVEF (Left Ventricular Ejection Fraction) \>50%
11. Ability and willingness to comply with the study protocol procedure
12. Life expectancy \> 6 months
13. Accessibility of patient for treatment and follow up
14. Written informed consent

Exclusion Criteria

1. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
2. Contraindication to any of the individual components of CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), including prior receipt of anthracyclines
3. 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
4. Stage I without bulky
5. Patients with transformed lymphoma
6. Prior therapy for DLBCL (Diffuse Large B Cell Lymphoma), with the exception of nodal biopsy or local irradiation
7. Previous exposure to cytotoxic agents
8. Suspect or clinical evidence of CNS (Central Nervous System) involvement by lymphoma
9. 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
10. 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)
11. Evidence of any severe active acute or chronic infection
12. Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Merli, MD

Role: PRINCIPAL_INVESTIGATOR

Ematologia - IRCCS Arcispedale Santa Maria Nuova

Locations

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A.O. Spedali Civili

Brescia, BS, Italy

Site Status

AUSL di Ravenna

Ravenna, RA, Italy

Site Status

Asmn-Irccs

Reggio Emilia, RE, Italy

Site Status

Ematologia 1U - AO Città della Salute e della Scienza

Torino, TO, Italy

Site Status

A.O. S. Maria di Terni

Terni, TR, Italy

Site Status

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

Alessandria, , Italy

Site Status

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

Ancona, , Italy

Site Status

A.O. Ospedale Degli Infermi

Biella, , Italy

Site Status

Area Vasta Romagna e IRST

Meldola (FC), , Italy

Site Status

IRCCS, Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

A.O. Universitaria Policlinico Di Modena

Modena, , Italy

Site Status

SCDU Ematologia - Università del Piemonte Orientale

Novara, , Italy

Site Status

Irccs Istituto Oncologico Veneto (Iov)

Padua, , Italy

Site Status

Oncoematologia e TMO Dopartimento Oncologia La Maddalena

Palermo, , Italy

Site Status

Ausl Di Rimini

Rimini, , Italy

Site Status

Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

Varese, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-005697-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FIL_GAEL

Identifier Type: -

Identifier Source: org_study_id