Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)

Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927797

Acronym

PERLL

Enrollment

185

Registered

2009-06-25

Start date

2005-02-28

Completion date

2012-01-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Chronic Lymphocytic Leukemia, B-Cell Non-Hodgkin's Lymphoma, Immunocytoma/Morbus Waldenström

Keywords

immunochemotherapy, Pentostatin, Cyclophosphamide, Rituximab, Maintenance, indolent B-NHL, B-CLL, B-NHL

Brief summary

The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized, multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered every three weeks. Patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over a period of 2 years.

Interventions

DRUGCyclophosphamide, Pentostatin, Rituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL * therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass * therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003) * age \> 18 years * anticipated life expectancy \> 6 months * ECOG 0-3 * no significant comorbidities * signed informed consent * efficient method of contraception during time of therapy (men and women)

Exclusion criteria

* age \< 18 years * CD20 negativity * significant comorbidities interfering with therapy as required by the protocol * history of HIV infection or active hepatitis

Design outcomes

Primary

Measure	Time frame
Efficacy: overall response rate	after 6 months and after 36 months

Secondary

Measure	Time frame
Toxicity according to WHO-Grading	throughout the treatment and until 36 months after
Efficacy: complete remission rate	after 6 months and 36 months
Efficacy: partial remission rate	after 6 months and 36 months
Efficacy: progression-free survival	after 6 months and 36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026