NCT00927797

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

3.9 years

First QC Date

June 23, 2009

Last Update Submit

June 24, 2009

Conditions

Immunocytoma/Morbus WaldenströmB-Cell Non-Hodgkin's LymphomaB-Cell Chronic Lymphocytic Leukemia

Keywords

immunochemotherapyPentostatinCyclophosphamideRituximabMaintenanceindolent B-NHLB-CLLB-NHL

Outcome Measures

Primary Outcomes (1)

  • Efficacy: overall response rate

    after 6 months and after 36 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

Immunochemotherapy, Maintencance

EXPERIMENTAL
Drug: Cyclophosphamide, Pentostatin, Rituximab

Interventions

Cyclophosphamide, Pentostatin, RituximabDRUG
Immunochemotherapy, Maintencance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal ZoneLymphoma, B-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CyclophosphamidePentostatinRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anthony D Ho, Ph.D., Prof.

    Director of Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

February 1, 2005

Primary Completion

January 1, 2009

Study Completion

January 1, 2012

Last Updated

June 25, 2009

Record last verified: 2009-06