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Combination treatment with immunochemotherapy (R-DHAP) and lenalidomide

Dosage:

Rituximab 375 mg/m² day 1, i.v. Cisplatin 100 mg/m² or Carboplatin AUC5 day 2, i.v. Cytarabine 2000 mg/m², administered twice, on day 3, i.v. Dexamethasone 40 mg, days 2-5, p.o. Lenalidomide 5-20 mg, day 1-7 / day-6-+7, p.o. PEG-Filgrastim 6 mg, day 6, s.c.

peripheral stem cell collection after cycle 1 or 2

Cytarabine 2000 mg/m², administered twice

5-20 mg administered either d1-d7, or d-6-d7

PegFilgrastim

collection of peripheral stem cells for autologous stem cell transplantation

peripheral stem cell collection

Bertram Glaß, MD

The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.

This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine, Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell non-hodgkin-lymphoma (NHL).

The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy will lead to an overall response rate of at least 60%. In this study, 3 rounds of immunochemotherapy in combination with lenalidomide will be administered. After the first or second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation treatment with autologous or allogenic peripheral blood stem cell transplantation is recommended in all patients suitable, but is not part of the study.

In phase 1, up to six cohorts of at least 6 patients each will be treated with the study therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose (MTD).

In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.

Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP

Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) With Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum (R²-DHAP)

The percentage of patients which showed either a partial remission (PR), a complete remission with remaining uncertainty (CRu) or a complete remission (CR) after study treatment.

The maximum dose of lenalidomide tolerated with acceptable toxicity during phase 1 of this study. The MTD established in phase 1 of this study will be administered to 50 patients in phase 2 of this study.

The rate of patients which show progressive disease (PD) during or directly after study therapy

The collection of peripheral stem cells is needed to be able to offer the patient high dose chemotherapy followed by autologous stem cell transplantation after the study treatment has ended.

Stem cell collection of \<2.0 \*10e6 CD34+cells/kg will be considered insufficient.

laboratory WBC \< 1.0 /nl or Plt \< 25 /nl

Celgene

Amgen

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

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Pts with biological age up to 55 y with advanced stage will receive 6 cycles of intensive treatment: blocks (A1-B1-C1-A2-B2-C2). If after A1 and B1 cycles CR is observed, the rest of the cycles will be administered with reduced doses.

In pts with biological age \>55 y with advanced stage block will receive A and B with attenuated doses (A1\*-B1\*-A2\*-B2\*-A3\*-B3\*).

Pts with biological age up to 55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 blocks. If CR is not reached, patients will complete the 6 treatment cycles.

Pts with a biological age \>55 y with localized stage (non-bulky I or II) with CR after 2 cycles will finish treatment after 4 attenuated blocks (A1\*-B1\*-A2\*-B2\*). If CR is not reached, patients will complete the 6 cycles of treatment.

Rituximab 375 mg/m² IV. Day 1. Cycles: A1/A1\*, B1/B1\*, C1/A2\*, A2/B2\*, B2/A3\*, C2/B3\*. Two additional doses after 6 cycles in case of localized stage patients without CR after four cycles or advanced stage patients.

Methotrexate 1500 mg/m² IV 24h-infusion. Day 2. Cycles: A1, B1, C1 (1000 mg/m² if patient in CR) , A2 (1000 mg/m² if patient in CR), B2 (1000 mg/m² if patient in CR) , C2 (1000 mg/m² if patient in CR) Methotrexate 500 mg/m² IV 24h-infusion. Day 2. Cycles: A1\*, B1\*, A2\*, B2\*, A3\*, B3\*

Dexamethasone 10 mg/m² PO or IV bolus. Days: 2 to 6. Cycles: A1/A1\*, B1/B1\*, C1/A2\*, A2/B2\*, B2/A3\*, C2/B3\*.

Iphosphamid 800 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1, A2 (500 mg/m² if patient in CR).

Iphosphamid 400 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1\*.

Iphosphamid

Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*

Etoposide (VP16) 100 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1, A2. Etoposide (VP16) 250 mg/m² IV in 1 hour. Days: 5, 6. Cycle: C1, C2. Etoposide (VP16) 60 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1\*, A2\*, A3\*.

Cytarabine 150 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1, A2 Cytarabine 2 g/m² IV in 3 hours every 12 hours. Day: 6. Cycle: C1 (1.5 g/m² if patient in CR), C2 (1.5 g/m² if patient in CR) Cytarabine 60 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1\*, A2\*, A3\*

Cyclophosphamide 200 mg/m² IV in 1 hour. Days 1 to 5. Pre-phase. Cyclophosphamide 200 mg/m² IV in 1 hour. Days 2 to 6. Cycles: B1, B2, B1\*, B2\*, B3\*

Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*

Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2

Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2

Methotrexate 12 mg IT. Day 1. Pre-phase Methotrexate 12 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2 Methotrexate 15 mg IT. Day 2. Cycles: A1\*, B1\*, A2\*, B2\*, A3\*, B3\*

Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2

Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

Carmen López-Carrero

Olga García Calduch

JOSEP MARIA RIBERA SANTASUSANA

JUAN MANUEL SANCHO CIA

Rodrigo Martino

Irene García Cadenas

Eva Gimeno

Pere Barba

Pau Abrisqueta

Santiago Mercadal

Clara Maluquer

Cristina Barrenetxea

Juan Miguel Bergua

Josefina Serrano

Izaskun Ceberio

Nerea Caminos

Maialen Sirvent

Maria Teresa Artola

Carlos Rodríguez

Antoni Garcia Guiñon

Buenaventura Buendía

Ana Jiménez

Mariana Bastos

Daniel García Belmonte

Laura Llorente

PIlar Herrera

Pilar Herrera

Reyes Arranz

Maria Paz Queipo de Llano

Teresa Bernal

Antònia Cladera

Jesús María Hernández-Rivas

Jesús Maria Hernández-Rivas

Maria José Penalva

Natalia Alonso

Marta Cervera

Ana Vicent

Ferran Vall-Llovera

Ana Sebrango

Maria José Terol

Pau Montesinos

Maria Paz Martínez Badas

JOSEP MARIA RIBERA SANTASUSANA, M.D.; Ph.D.

JUAN MANUEL SANCHO CIA, M.D.; Ph.D.

Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.

Patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. Patients older than 55 years will receive the six blocks with attenuated chemotherapy.

Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Defined as the time from diagnosis to death by any cause or last follow-up.

Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.

Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

PETHEMA Foundation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP	NCT02983097	Diffuse Large B... Follicular Lymp... Mantle Cell Lym... Burkitt Lymphom... Aggressive Marg...	Rituximab Cisplatin Carboplatin Dexamethasone Cytarabine Lenalidomide PegFilgrastim peripheral stem...	18 Years - 70 Years	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.	NCT05049473	Mature B-Cell L... Burkitt Lymphom... Unclassifiable ...	Rituximab Methotrexate Dexamethasone Iphosphamid Vincristine Etoposide Cytarabine Cyclophosphamid... Doxorubicin Vindesine Cytarabine Methotrexate Hydrocortisone Prednisone	18 Years -	PETHEMA Foundation

Spots Global Cancer Trial Database for burkitt lymphoma (bl)