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

NCT02495454 | Terminated Phase 2 Results

• 2 other identifiers: FIL_GAEL2014-005697-10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

CD20 Positive Diffuse Large B-cell Lymphoma; Elderly Unfit Patients

Outcome Measures

Primary Outcomes (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.

  Up to 36 months.

Secondary Outcomes (9)

• Adverse Events (AEs)

  Up to 36 months

• Partial Response Rate (PRR)

  Up to 36 months

• ORR (Overall Response Rate)

  Up to 36 months

• OS (Overall Survival)

  Up to 36 months

• PFS (Progression Free Survival)

  Up to 36 months

Study Arms (1)

Ga101-miniCHOP

EXPERIMENTAL

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.

Drug: Ga101

Interventions

Ga101 DRUG

Also known as: Obinutuzumab

Ga101-miniCHOP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (16)

A.O. Spedali Civili

Brescia, BS, 25100, Italy

Location

AUSL di Ravenna

Ravenna, RA, 48100, Italy

Location

Asmn-Irccs

Reggio Emilia, RE, 43123, Italy

Location

Ematologia 1U - AO Città della Salute e della Scienza

Torino, TO, 10126, Italy

Location

A.O. S. Maria di Terni

Terni, TR, 05100, Italy

Location

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

Alessandria, 15121, Italy

Location

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

Ancona, 60126, Italy

Location

A.O. Ospedale Degli Infermi

Biella, 13900, Italy

Location

Area Vasta Romagna e IRST

Meldola (FC), Italy

Location

IRCCS, Istituto Nazionale dei Tumori

Milan, Italy

Location

A.O. Universitaria Policlinico Di Modena

Modena, 41124, Italy

Location

SCDU Ematologia - Università del Piemonte Orientale

Novara, 28100, Italy

Location

Irccs Istituto Oncologico Veneto (Iov)

Padua, 35128, Italy

Location

Oncoematologia e TMO Dopartimento Oncologia La Maddalena

Palermo, Italy

Location

Ausl Di Rimini

Rimini, 47924, Italy

Location

Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI

Varese, 21100, Italy

Location

MeSH Terms

Interventions

obinutuzumab

Results Point of Contact

• Title: Dr. Luigi Marcheselli - FIL statistician
• Organization: Fondazione Italiana Linfomi ONLUS

lmarcheselli@filinf.it

059 4223873

Study Officials

• Francesco Merli, MD

  Ematologia - IRCCS Arcispedale Santa Maria Nuova

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: July 13, 2015
• Study Start: August 25, 2015
• Primary Completion: March 22, 2017
• Study Completion: March 22, 2017
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-08

Locations

IT (16)