Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
NCT ID: NCT04442412
Last Updated: 2022-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
430 participants
INTERVENTIONAL
2021-03-23
2030-09-01
Brief Summary
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All patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.
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Detailed Description
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Patients randomized to Arm A will receive a prephase with oral prednisone (50 mg for 7 days \[day -6 to day 0\]) followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.
If patients randomized to arm A are already on VitD, they are allowed to continue receiving VitD supplementation at a dose that can be considered part of the standard of care and does not exceed the maximum standard VitD dose recommended for general adult and elderly population , up to 10,000 U/week VitD .
If clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase ; in this case vincristine administration in cycle 1 of immunochemotherapy should be skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.
Patients randomized to Arm B will receive a prephase with oral prednisone and a prephase therapy with VitD according to the below reported schedule followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.
Schedule for VitD (Cholecalciferol) supplementation: 25,000 U/day starting on day -6:
daily loading dose for 7 days if 25 VitD baseline level 20-40 ng/ml daily loading dose for 14 days if 25 VitD baseline level \< 20 ng/ml followed by weekly maintenance supplementation of 25,000 U for the entire duration of immunochemotherapy (6 courses every 21 days - 18 weeks), regardless of the baseline level of 25 VitD.
If clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase (DAY -6); in this case vincristine administration in cycle 1 of immunochemotherapy should be: skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.
Patients with 25(OH)VitD levels \<30 ng/ml on d1 cycle 2 will receive and additional loading phase of Cholecalciferol 25,000 U/day for 7 days and then 25,000 U once weekly for the duration of immunochemotherapy.
Patients may continue with VitD supplementation after the end of the immunochemotherapy at a (reduced) standard dose of 25,000 U once a month for up to 2 years from end of immunochemotherapy.
Patients experimenting toxicity leading to a delay in treatment administration \> 4 weeks will discontinue study treatment and will be addressed to a salvage treatment: these patients will be followed-up for survival until the end of the study.
Consolidation radiotherapy:
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm B (Experimental):
Patients randomized to Arm B will receive a prephase with oral prednisone and a prephase therapy with VitD according to the below reported schedule followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.
Schedule for VitD supplementation: 25,000 U/day starting on day -6:
daily loading dose for 7 days if 25 VitD baseline level 20-40 ng/ml daily loading dose for 14 days if 25 VitD baseline level \< 20 ng/ml followed by weekly maintenance supplementation of 25,000 U for the entire duration of immunochemotherapy (6 courses every 21 days - 18 weeks), regardless of the baseline level of 25 VitD.
Vitamin D3 (Cholecalciferol)
patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.
RCHOP o R-miniCHOP at standard doses
Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP
o R-miniCHOP at standard doses
Arm A (Standard arm)
Patients randomized to Arm A will receive a prephase with oral prednisone followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.
If patients randomized to arm A are already on VitD, they are allowed to continue receiving VitD supplementation at a dose that can be considered part of the standard of care and does not exceed the maximum standard VitD dose recommended for general adult and elderly population , up to 10,000 U/week VitD
RCHOP o R-miniCHOP at standard doses
Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP
o R-miniCHOP at standard doses
Interventions
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Vitamin D3 (Cholecalciferol)
patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.
RCHOP o R-miniCHOP at standard doses
Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP
o R-miniCHOP at standard doses
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 65 years
3. Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.
4. Eastern Cooperative Oncology Group performance status (PS) ≤3
5. Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)
6. No previous treatment for DLBCL or Follicular grade IIIb lymphoma
7. Ann Arbor stage I-IV
8. At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan
9. Serum basic levels of Vitamin D \[25 (OH) VitD\] ≤ 40 ng / ml;
10. Adequate hematological counts defined as follows:
* Absolute Neutrophil count \> 1.5 x 109/L unless due to bone marrow involvement by lymphoma
* Platelet count ≥ 80.000/mm3 unless due to bone marrow involvement by lymphoma
11. Adequate renal function defined as follows:
\- Creatinine ≤ 2 mg/dL, unless secondary to lymphoma
12. Adequate hepatic function defined as follows:
\- Bilirubin ≤ 2 mg/dL unless secondary to lymphoma
13. LVEF \> 50% at bidimensionally echocardiogram
14. Life expectancy ≥ 6 months
15. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures
16. Subject must be able to adhere to the study visit schedule and other protocol requirements
17. Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on study.
Exclusion Criteria
2. Use of VitD supplementation as standard of care at dose higher than 10,000 U/week
3. Suspect or clinical evidence of CNS involvement by lymphoma
4. Contraindication to the use of rituximab
5. Contraindication to the use of VitD supplementation (Hypercalcemia/Hyperphosphatemia)
6. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug
7. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
8. Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin or limited stage surgically removed breast cancer or adequately treated with radiation therapy or limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy or previous malignancy confined and surgically resected with curative intent
9. Evidence of other clinically significant uncontrolled condition including, but not limited to:
* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* Chronic hepatitis B virus or hepatitis C requiring treatment.
65 Years
ALL
No
Sponsors
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GRADE Onlus
OTHER
Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Francesco Merli, Dott.
Role: PRINCIPAL_INVESTIGATOR
Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS
Locations
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SC Ematologia Spedali Civili
Brescia, BS, Italy
UO Ematologia e CTMO di Piacenza
Piacenza, PC, Italy
Ospedale Oncologico regionale CROB
Rionero in Vulture, Piacenza, Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, , Italy
Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia
Ascoli Piceno, , Italy
Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano, , Italy
Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, , Italy
Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni
Bergamo, , Italy
Biella - Ospedale Degli Infermi - S.C. Oncologia
Biella, , Italy
Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia
Campobasso, , Italy
Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, , Italy
Unità Funzionale di Ematologia AOU Careggi
Florence, , Italy
Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia
Frosinone, , Italy
Matera - Ospedale Madonna delle Grazie - Ematologia
Matera, , Italy
Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
Meldola, , Italy
Mestre - Ospedale Dell Angelo - U.O. Ematologia
Mestre, , Italy
SC Ematologia AO Niguarda Cà Granda
Milan, , Italy
Monza - ASST MONZA Ospedale S. Gerardo - Ematologia
Monza, , Italy
Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
Napoli, , Italy
Università del Piemonte Orientale - Novara
Novara, , Italy
Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padua, , Italy
Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, , Italy
Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, , Italy
Palermo - AOU Policlinico Giaccone - Ematologia
Palermo, , Italy
UO Ematologia Università - Policlinico San Matteo
Pavia, , Italy
Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, , Italy
Potenza - AOR San Carlo
Potenza, , Italy
UO Ematologia Ospedale Santa Maria delle Croci
Ravenna, , Italy
Reggio Emilia - AO Santa Maria Nuova
Reggio Emilia, , Italy
UO Ematologia - Ospedale degli Infermi
Rimini, , Italy
Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive
Roma, , Italy
Roma - Ospedale S. Camillo - Ematologia
Roma, , Italy
Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, , Italy
Università Cattolica S. Cuore, Ematologia
Roma, , Italy
Università La Sapienza Ematologia
Roma, , Italy
UOC Ematologia - A.O. Sant'Andrea
Roma, , Italy
Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia
Salerno, , Italy
San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia
San Giovanni Rotondo, , Italy
Sassari - AOU di Sassari - Ematologia
Sassari, , Italy
UOC Medicina Interna MO DH Oncologico
Sassuolo, , Italy
UOC Ematologia, AOU Senese
Siena, , Italy
Univ. Perugia Sede Terni - Oncoematologia
Terni, , Italy
AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, , Italy
SC. Ematologia A.O. Città della Salute e della Scienza
Torino, , Italy
Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche
Torino, , Italy
Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, , Italy
Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, , Italy
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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Luca Palumbo
Role: backup
Giorgio Priolo
Role: backup
Other Identifiers
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FIL_PREVID
Identifier Type: -
Identifier Source: org_study_id
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