Phase II study of cytarabine and etoposide in children with refractory or relapsed non-Hodgkin's lymphoma: a study of the French Society of Pediatric Oncology.

1990 ◽  
Vol 8 (4) ◽  
pp. 661-665 ◽  
Author(s):  
J C Gentet ◽  
C Patte ◽  
E Quintana ◽  
C Bergeron ◽  
H Rubie ◽  
...  
Keyword(s):  
Bone Marrow ◽  
B Cell ◽  
Continuous Infusion ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hodgkin's Lymphoma ◽  
High Dose ◽  
Refractory Disease ◽  
Cns Disease ◽  
Non Hodgkin's Lymphoma

Twenty-five children or adolescents with relapsed or refractory non-Hodgkin's lymphoma (NHL) were included in this phase II study of the combination of cytarabine (ARA-C) 50 mg/m2/d by 12 hours continuous infusion day 1 to day 5, ARA-C 3 g/m2/d in 3 hours day 1 to day 4, and etoposide (VP 16) 200 mg/m2 daily from day 1 to day 4. Twelve patients had B-cell, 12 T-cell, and one non-T, non-B-cell lymphoma; according to Murphy's staging system, 15 had stage III and nine stage IV disease with bone marrow involvement at diagnosis. All had previously received ARA-C by push or continuous infusion. Two patients had received epipodophyllotoxins. At the time of the study, three children had initial refractory disease, 18 were in first relapse (14 on therapy), two in first refractory relapse, and two in second relapse (on therapy). The overall response rate (RR) was 60%: eight complete responses (CRs), seven partial responses (PRs) (two became CRs after a second course). The RR was 66% (four CRs plus four PRs) in B-cell and 54% (four CRs, three PRs) in non-B-cell NHL. It was 20% (one PR per five patients) in initial or relapsed refractory disease. In four patients with measurable CNS disease, there were three CRs. Duration of response was nonassessable since all the responding patients received high-dose polychemotherapy followed by autologous bone marrow transplantation (ABMT) (five are alive with long follow-up [FU]). Toxicity was marked mostly by pancytopenia for 2 weeks, and half the patients encountered a grade-3 infection. One severe diarrhea was observed. In conclusion, high-dose ARA-C (HD-ARA-C) and VP 16 are an effective regimen in relapsed NHL, especially with CNS disease, and its toxicity is acceptable with regards to the prognosis of the disease.

High‐dose cyclophosphamide for hard‐to‐treat patients with relapsed or refractory B‐cell non‐Hodgkin's lymphoma, a phase II result

2020 ◽  
Vol 104 (4) ◽  
pp. 281-290
Author(s):  
Jean‐Marie Michot ◽  
Maxime Annereau ◽  
Alina Danu ◽  
Clémence Legoupil ◽  
Louis Bertin ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Hodgkin’S Lymphoma ◽  
Hodgkin's Lymphoma ◽  
High Dose ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Phase II study of oblimersen sodium and rituximab in patients with recurrent B-cell non-Hodgkin’s lymphoma

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 6611-6611 ◽  
Author(s):  
B. Pro ◽  
M. R. Smith ◽  
B. Leber ◽  
A. Younes ◽  
L. Fayad ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Hodgkin’S Lymphoma ◽  
Phase Ii Study ◽  
Hodgkin's Lymphoma ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma

Results of a Phase II Study of Pixantrone in Combination with Cyclophosphamide, Vincristine, and Prednisone in Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 529-529 ◽  
Author(s):  
Peter Borchmann ◽  
Raoul Herbrecht ◽  
Martin Wilhelm ◽  
Franck Morschhauser ◽  
Georg Hess ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Hodgkin’S Lymphoma ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Median Number ◽  
Hodgkin's Lymphoma ◽  
Efficacy And Safety ◽  
Non Hodgkin's Lymphoma ◽  
Large B Cell

Abstract Background: Pixantrone is a novel aza-anthracenedione with less cardiotoxicity and superior activity compared to doxorubicin and mitoxantrone in murine leukemia and lymphoma tumor models. Pixantrone as single agent therapy led to major responses in patients (pts) with multiply relapsed aggressive non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLCL). In a phase I dose-ranging study of pixantrone (80 to 180 mg/m2) replacing doxorubicin (CPOP) in a CHOP-like regimen, the optimal dose (RD) from that study was found to be 150 mg/m2. Methods: In this international, multi-center, phase II study the primary objective was to assess the efficacy and safety of the CPOP regimen (cyclophosphamide 750 mg/m2d1, pixantrone 150 mg/m2d1, vincristine 1.4 mg/m2 d1, limited to 2 mg, and prednisone 100mg d1 to 5) in pts with relapsed DLCL, transformed follicular lymphoma (tFL) and mantle cell lymphoma (MCL) for a total of 6 cycles, given every 3 weeks. Response was assessed according to the standardized response criteria for NHL. Hematopoietic growth factors were not permitted for the first cycle and were used thereafter according to the ASCO guidelines. Main eligibility criteria included at least one but not more than two previous chemotherapy lines containing an anthracycline/anthracenedione with a cumulative dose of less than 450 mg/m2doxorubicin equivalent, a left ventricular ejection fraction (LVEF) > 50%, absence of CNS lymphoma, and negative HIV serology. Results: Thirty pts were included in this phase II study and are available for efficacy and safety assessment. Main baseline characteristics were: median age, 66 y (range 26–76); median baseline International Prognostic Index (IPI), 2 (11/30 pts had IPI 3 or 4); median number of previous therapy lines, 2 (1–7); median time since last chemotherapy, 14 months (1–202). Median number of cycles of study drug received was 6 (1–6). The overall response rate (ORR) was 73%, with 14 (47%) pts achieving complete response (CR/CRu) and 8 (26%) pts with partial responses (PR). For responses lasting at least 8 weeks (63%), the median duration of response was 10.3 months (range 2.5 to 27). The most common severe toxicities were gr 3/4 neutropenia, 29 (97%) pts; gr 3 febrile neutropenia, 6 (20%); gr 3 anemia, 9 (30%); gr 3/4 thrombocytopenia, 6 (20%); gr 3/4 infections, 5 (17%). Four pts had a decrease in LVEF >10% and ≤20% as determined by MUGA-scan. One of these patients developed symptomatic right heart failure classified by the investigator as related to progressive NHL. Two pts experienced transient LVEF decline > 20% during long-term follow up. Conclusions: The CPOP combination therapy with 150 mg/m2 pixantrone results in a high ORR (73%) with 47% CRs. Furthermore, it exhibits an acceptable toxicity profile and can be administered safely in an outpatient setting even in this cohort of elderly, anthracycline-pretreated patients. Based on these results, a randomized Phase II study comparing CPOP-rituximab with CHOP-rituximab in patients with untreated diffuse large-B-cell NHL has been initiated.

CAMPATH-1H monoclonal antibody in therapy for previously treated low-grade non-Hodgkin's lymphomas: a phase II multicenter study. European Study Group of CAMPATH-1H Treatment in Low-Grade Non-Hodgkin's Lymphoma.

1998 ◽  
Vol 16 (10) ◽  
pp. 3257-3263 ◽  
Author(s):  
J Lundin ◽  
A Osterborg ◽  
G Brittinger ◽  
D Crowther ◽  
H Dombret ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Bone Marrow ◽  
B Cell ◽  
Mycosis Fungoides ◽  
Phase Ii ◽  
Infectious Complications ◽  
Hodgkin's Lymphoma ◽  
Low Grade ◽  
Non Hodgkin's Lymphoma ◽  
Previously Treated

PURPOSE CAMPATH-1H is a human immunoglobulin G1 (IgG1) anti-CD52 monoclonal antibody (MAb) that binds to nearly all B-cell and T-cell lymphomas. We report here the results of a multicenter phase II trial of CAMPATH-1H in patients with advanced, low-grade non-Hodgkin's lymphoma (NHL) who were previously treated with chemotherapy. PATIENTS AND METHODS Fifty patients who had relapsed (n=25) after or were resistant (n = 25) to chemotherapy were treated with CAMPATH-1H 30 mg administered as a 2-hour intravenous (i.v.) infusion three times weekly for a maximum period of 12 weeks. RESULTS Six patients (14%) with B-cell lymphomas achieved a partial remission (PR). Patients with mycosis fungoides appeared to respond more frequently (50%; four of eight patients, which included two complete remissions [CRs]). Lymphoma cells were rapidly eliminated from blood in 16 of 17 patients (94%). CR in the bone marrow was obtained in 32% of the patients. Lymphoma skin lesions disappeared completely in four of 10 patients and partial regression was obtained in three patients. Lymphadenopathy and splenomegaly were normalized in only 5% and 15% of patients, respectively. Lymphopenia (< 0.5 x 10(9)/L) occurred in all patients. World Health Organization (WHO) grade IV neutropenia occurred in 14 patients (28%). Opportunistic infections were diagnosed in seven patients and nine patients had bacterial septicemia. Death related to infectious complications occurred in three patients. CONCLUSION CAMPATH-1H had a significant but limited activity in patients with advanced, heavily pretreated NHL. The most pronounced effects were noted in the blood and bone marrow and in patients with mycosis fungoides. The risk for serious infectious complications needs to be considered for severely ill patients who are evaluated for CAMPATH-1H treatment.

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