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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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Plerixafor

Anti-HIV Agents

Anti-Retroviral Agents

All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen.

All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen.

240 mcg/kg/day based on ideal body weight will be given for the following conditions:

1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5.
2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis.
3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.

All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient:

* Standard risk: 5 μg/kg SQ BID.
* High risk: 10 μg/kg SQ BID.

Filgrastim

Jack W Hsu, MD

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.

The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period.

The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters:

* Peripheral CD34 cell counts on each day of apheresis.
* Total CD34 cells collected on each day of apheresis
* Multiple myeloma vs. NHL.

Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.

University of Florida

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
Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation	NCT01339572	Non-Hodgkin's L... Multiple Myelom...	Plerixafor Filgrastim	18 Years -	University of Florida

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